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Sample records for antifibrinolytic trial tranexamic

  1. Antifibrinolytics in liver surgery

    Directory of Open Access Journals (Sweden)

    Jalpa Makwana

    2010-01-01

    Full Text Available Hyperfibrinolysis, a known complication of liver surgery and orthotopic liver transplantation (OLT, plays a significant role in blood loss. This fact justifies the use of antifibrinolytic drugs during these procedures. Two groups of drug namely lysine analogues [epsilon aminocaproic acid (EACA and tranexamic acid (TA] and serine-protease-inhibitors (aprotinin are frequently used for this purpose. But uniform data or guidelines on the type of antifibrinolytic drugs to be used, their indications and correct dose, is still insufficient. Antifibrinolytics behave like a double-edged sword. On one hand, there are benefits of less transfusion requirements but on the other hand there is potential complication like thromboembolism, which has been reported in several studies. We performed a systematic search in PubMed and Cochrane Library, and we included studies wherein antifibrinolytic drugs (EACA, TA, or aprotinin were compared with each other or with controls/placebo. We analysed factors like intraoperative red blood cell and fresh frozen plasma requirements, the perioperative incidence of hepatic artery thrombosis, venous thromboembolic events and mortality. Among the three drugs, EACA is least studied. Use of extensively studied drug like aprotinin has been restricted because of its side effects. Haemostatic effect of aprotinin and tranexamic acid has been comparable. However, proper patient selection and individualized treatment for each of them is required. Purpose of this review is to study various clinical trials on antifibrinolytic drugs and address the related issues like benefits claimed and associated potential complications.

  2. Tranexamic acid for upper gastrointestinal bleeding

    DEFF Research Database (Denmark)

    Gluud, Lise Lotte; Klingenberg, Sarah Louise; Langholz, Ebbe

    2012-01-01

    Tranexamic acid reduces haemorrhage through its antifibrinolytic effects. In a previous version of the present review, we found that tranexamic acid may reduce mortality. The present review includes updated searches of randomised trials on tranexamic acid versus placebo, cimetidine or lansoprazole....

  3. Antifibrinolytics in liver surgery

    OpenAIRE

    Jalpa Makwana; Saloni Paranjape; Jyotsna Goswami

    2010-01-01

    Hyperfibrinolysis, a known complication of liver surgery and orthotopic liver transplantation (OLT), plays a significant role in blood loss. This fact justifies the use of antifibrinolytic drugs during these procedures. Two groups of drug namely lysine analogues [epsilon aminocaproic acid (EACA) and tranexamic acid (TA)] and serine-protease-inhibitors (aprotinin) are frequently used for this purpose. But uniform data or guidelines on the type of antifibrinolytic drugs to be used, their indica...

  4. Tranexamic acid for upper gastrointestinal bleeding

    DEFF Research Database (Denmark)

    Bennett, Cathy; Klingenberg, Sarah Louise; Langholz, Ebbe;

    2014-01-01

    Background Tranexamic acid reduces haemorrhage through its antifibrinolytic effects. In a previous version of the present review, we found that tranexamic acid may reduce mortality. This review includes updated searches and new trials.Objectives To assess the effects of tranexamic acid versus......-effect and random-effects model meta-analyses and presented results as risk ratios (RRs) with 95% confidence intervals (CIs) and used I² as a measure of between-trial heterogeneity. We analysed tranexamic acid versus placebo or no intervention and tranexamic acid versus antiulcer drugs separately. To analyse...... sources of heterogeneity and robustness of the overall results, we performed subgroup, sensitivity and sequential analyses.Main results We included eight randomised controlled trials on tranexamic acid for upper gastrointestinal bleeding. Additionally, we identified one large ongoing pragmatic randomised...

  5. Anti-hemorrhagic effect of prophylactic tranexamic acid in benign hysterectomy-a double-blinded randomized placebo-controlled trial

    DEFF Research Database (Denmark)

    Topsoee, Märta Fink; Bergholt, Thomas; Ravn, Pernille;

    2016-01-01

    and in 2004, 8% of all women in Denmark undergoing benign hysterectomy experienced a bleeding complication. Tranexamic acid is an antifibrinolytic agent that has shown to effectively reduce bleeding complications within other surgical and medical areas. However, knowledge about the drug's effect in relation...... to benign hysterectomy is still missing. OBJECTIVE: To investigate the antihemorrhagic effect of prophylactic tranexamic acid in elective benign hysterectomy. STUDY DESIGN: A double-blinded randomized placebo-controlled trial was conducted at 4 gynecological departments in Denmark from April 2013 to October...... 2014. A total of 332 women undergoing benign abdominal, laparoscopic, or vaginal hysterectomy were included in the trial, randomized to either 1 g of intravenous tranexamic acid or placebo at start of surgery. Chi-square test and Student t test statistical analyses were applied. RESULTS: The primary...

  6. A comparison of high-dose and low-dose tranexamic acid antifibrinolytic protocols for primary coronary artery bypass surgery

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    Stephen M McHugh

    2016-01-01

    Full Text Available Background and Aims: Tranexamic acid (TA is used for prophylactic antifibrinolysis in coronary artery bypass surgeries to reduce bleeding. We evaluated the efficacy of two different doses of TA for prophylactic antifibrinolysis in patients undergoing primary coronary artery bypass grafting (CABG surgery in this retrospective cohort study at a tertiary care referral centre. Methods: One-hundred eighty-four patients who underwent primary CABG with cardiopulmonary bypass (CPB via sternotomy between January 2009 and June 2011 were evaluated. Pre-operative patient characteristics, intraoperative data, post-operative bleeding, transfusions, organ dysfunction and 30-day mortality were compared between high-dose TA (30 mg/kg loading dose followed by infusion of 15 mg/kg/h until the end of surgery along with 2 mg/kg priming dose in the bypass circuit and low-dose TA (15 mg/kg loading dose followed by infusion of 6 mg/kg/h until the end of surgery along with 1 mg/kg priming dose in the bypass circuit groups. Univariate comparative analysis of all categorical and continuous variables was performed between the two groups by appropriate statistical tests. Linear and logistic regression analyses were performed to control for the effect of confounding on the outcome variables. Results: Chest tube output, perioperative transfusion of blood products and incidence of re-exploration for bleeding did not differ significantly (P> 0.05 between groups. Post-operative complications and 30-day mortality were comparable between the groups. The presence of cardiogenic shock and increased pre-operative creatinine were found to be associated with increased chest tube output on the post-operative day 2 by multivariable linear regression model. Conclusions: Low-dose TA protocol is as effective as high-dose protocol for antifibrinolysis in patients undergoing primary CABG with CPB.

  7. Efficacy and Safety of Antifibrinolytic Agents in Reducing Perioperative Blood Loss and Transfusion Requirements in Scoliosis Surgery: A Systematic Review and Meta-Analysis

    OpenAIRE

    WANG, Meng; Zheng, Xin-Feng; Jiang, Lei-Sheng

    2015-01-01

    Background Routine use of antifibrinolytic agents in spine surgery is still an issue of debate. Objective To gather scientific evidence for the efficacy and safety of antifibrinolytic agents including aprotinin, tranexamic acid (TXA) and epsilon aminocaproic acid (EACA, traditionally known as Amicar) in reducing perioperative blood loss and transfusion requirements in scoliosis surgery. Methods We conducted a systematic review and meta-analysis for randomized controlled trials (RCTs), retrosp...

  8. Antifibrinolytics in cardiac surgery

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    Achal Dhir

    2013-01-01

    Full Text Available Cardiac surgery exerts a significant strain on the blood bank services and is a model example in which a multi-modal blood-conservation strategy is recommended. Significant bleeding during cardiac surgery, enough to cause re-exploration and/or blood transfusion, increases morbidity and mortality. Hyper-fibrinolysis is one of the important contributors to increased bleeding. This knowledge has led to the use of anti-fibrinolytic agents especially in procedures performed under cardiopulmonary bypass. Nothing has been more controversial in recent times than the aprotinin controversy. Since the withdrawal of aprotinin from the world market, the choice of antifibrinolytic agents has been limited to lysine analogues either tranexamic acid (TA or epsilon amino caproic acid (EACA. While proponents of aprotinin still argue against its non-availability. Health Canada has approved its use, albeit under very strict regulations. Antifibrinolytic agents are not without side effects and act like double-edged swords, the stronger the anti-fibrinolytic activity, the more serious the side effects. Aprotinin is the strongest in reducing blood loss, blood transfusion, and possibly, return to the operating room after cardiac surgery. EACA is the least effective, while TA is somewhere in between. Additionally, aprotinin has been implicated in increased mortality and maximum side effects. TA has been shown to increase seizure activity, whereas, EACA seems to have the least side effects. Apparently, these agents do not differentiate between pathological and physiological fibrinolysis and prevent all forms of fibrinolysis leading to possible thrombotic side effects. It would seem prudent to select the right agent knowing its risk-benefit profile for a given patient, under the given circumstances.

  9. Double blind, placebo-controlled trial of Tranexamic acid on recent internal hemorrhoid bleeding

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    Abdul A. Rani

    2002-12-01

    Full Text Available Double blind randomized placebo controlled trial was conducted to evaluate the efficacy of Tranexamic acid in 54 patients with recent hemorrhoid bleeding. Age, gender, body weight, height, grade of hemorrhoid, time of onset of recent bleeding were comparable between two groups. Analysis of haemostatic effect or stop bleeding as an immediate outcome of this study revealed that in the grade 2 patients, 23/23 (100% of tranexamic group and 18/23(78.26% of placebo group the bleeding stop. After 3 days of observation, there was statistically significant different for the rate of stop bleeding as well as at the end of observation. Bleeding stop earlier in the Tranexamic group with median 4 days (3-5 days, compare to placebo, median 11(9.55-12.45. Analysis of recurrent bleeding as an outcome of this study revealed that in the placebo group 9/18(50% of grade 2 patients and all grade 3 (100%patients suffered from recurrent bleeding. Since the days 4, both group have significant different time for recurrent bleeding and at the end of observation, cumulative probability of free of bleeding between two groups significantly different. Median still stop bleeding in the placebo group was 36 days, and the tranexamic group never reaches the median until the end of observation. Conclusion: tranexamic acid was an effective drug to stop recent hemorrhoid bleeding and prevent further recurrent bleeding, significantly better than placebo. (Med J Indones 2002;11: 215-21Keywords: Tranexamic acid, hemorrhoid bleeding, haemostatic effect, recurrent bleeding.

  10. CRASH-2 Study of Tranexamic Acid to Treat Bleeding in Trauma Patients: A Controversy Fueled by Science and Social Media

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    Sophia Binz

    2015-01-01

    Full Text Available This paper reviews the application of tranexamic acid, an antifibrinolytic, to trauma. CRASH-2, a large randomized controlled trial, was the first to show a reduction in mortality and recommend tranexamic acid use in bleeding trauma patients. However, this paper was not without controversy. Its patient recruitment, methodology, and conductance in moderate-to-low income countries cast doubt on its ability to be applied to trauma protocols in countries with mature trauma networks. In addition to traditional vetting in scientific, peer-reviewed journals, CRASH-2 came about at a time when advances in communication technology allowed debate and influence to be leveraged in new forms, specifically through the use of multimedia campaigns, social media, and Internet blogs. This paper presents a comprehensive view of tranexamic acid utilization in trauma from peer-reviewed evidence to novel multimedia influences.

  11. Can local application of Tranexamic acid reduce post-coronary bypass surgery blood loss? A randomized controlled trial

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    Latter David

    2009-06-01

    Full Text Available Abstract Background Diffuse microvascular bleeding remains a common problem after cardiac procedures. Systemic use of antifibrinolytic reduces the postoperative blood loss. The purpose of this study was to examine the effectiveness of local application of tranexamic acid to reduce blood loss after coronary artery bypass grafting (CABG. Methods Thirty eight patients scheduled for primary isolated coronary artery bypass grafting were included in this double blind, prospective, randomized, placebo controlled study. Tranexamic acid (TA group (19 patients received 1 gram of TA diluted in 100 ml normal saline. Placebo group (19 patients received 100 ml of normal saline only. The solution was purred in the pericardial and mediastinal cavities. Results Both groups were comparable in their baseline demographic and surgical characteristics. During the first 24 hours post-operatively, cumulative blood loss was significantly less in TA group (median of 626 ml compared to Placebo group (median of 1040 ml (P = 0.04. There was no significant difference in the post-op Packed RBCs transfusion between both groups (median of one unit in each (P = 0.82. Significant less platelets transfusion required in TA group (median zero unit than in placebo group (median 2 units (P = 0.03. Apart from re-exploration for excessive surgical bleeding in one patient in TA group, no difference was found in morbidity or mortality between both groups. Conclusion Topical application of tranexamic acid in patients undergoing primary coronary artery bypass grafting led to a significant reduction in postoperative blood loss without adding extra risk to the patient.

  12. Efficacy of prophylactic tranexamic acid in reducing blood loss during and after caesarean section

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    Bhavana G.

    2016-06-01

    Conclusions: Injection tranexamic acid is the, antifibrinolytic agent that can be used for prophylactic administration before caesarean section for decreasing blood loss during surgery. [Int J Reprod Contracept Obstet Gynecol 2016; 5(6.000: 2011-2016

  13. Temporal changes in clot lysis and clot stability following tranexamic acid in cardiac surgery

    DEFF Research Database (Denmark)

    Tang, Mariann; Wierup, Per; Rea, Catherine J;

    2016-01-01

    Cardiac surgery induces a multifactorial coagulopathy. Regular use of tranexamic acid (TXA) is becoming standard of care. Clinical challenges include selecting optimal dosing regimen and balancing the benefit versus risk of additional dosing with antifibrinolytics. The objective was to evaluate...

  14. Tranexamic acid-induced fixed drug eruption

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    Natsuko Matsumura

    2015-01-01

    Full Text Available A 33-year-old male showed multiple pigmented patches on his trunk and extremities after he took tranexamic acid for common cold. He stated that similar eruptions appeared when he was treated with tranexamic acid for influenza 10 months before. Patch test showed positive results at 48 h and 72 h by 1% and 10% tranexamic acid at the lesional skin only. To our knowledge, nine cases of fixed drug eruption induced by tranexamic acid have been reported in Japan. Tranexamic acid is a safe drug and frequently used because of its anti-fibrinolytic and anti-inflammatory effects, but caution of inducing fixed drug eruption should be necessary.

  15. Efficacy and Safety of Antifibrinolytic Agents in Reducing Perioperative Blood Loss and Transfusion Requirements in Scoliosis Surgery: A Systematic Review and Meta-Analysis.

    Directory of Open Access Journals (Sweden)

    Meng Wang

    Full Text Available Routine use of antifibrinolytic agents in spine surgery is still an issue of debate.To gather scientific evidence for the efficacy and safety of antifibrinolytic agents including aprotinin, tranexamic acid (TXA and epsilon aminocaproic acid (EACA, traditionally known as Amicar in reducing perioperative blood loss and transfusion requirements in scoliosis surgery.We conducted a systematic review and meta-analysis for randomized controlled trials (RCTs, retrospective case-control studies, and retrospective cohort studies on the use of antifibrinolytic agents in scoliosis surgery by searching in the MEDLINE and EMBASE databases and the Cochrane Database of Systematic Reviews and Controlled Trials of papers published from January 1980 through July 2014. Safety of the antifibrinolytic agents was evaluated in all included studies, while efficacy was evaluated in RCTs.Eighteen papers with a total of 1,158 patients were eligible for inclusion in this study. Among them, 8 RCTs with 450 patients were included for evaluation of pharmacologic efficacy (1 RCT was excluded because of a lack of standard deviation data. Mean blood loss was reduced in patients with perioperative use of antifibrinolytic agents by 409.25 ml intraoperatively (95% confidence interval [CI], 196.57-621.94 ml, 250.30 ml postoperatively (95% CI, 35.31-465.30, and 601.40 ml overall (95% CI, 306.64-896.16 ml. The mean volume of blood transfusion was reduced by 474.98 ml (95% CI, 195.30-754.67 ml. The transfusion rate was 44.6% (108/242 in the patients with antifibrinolytic agents and 68.3% (142/208 in the patients with placebo. (OR 0.38; 95% CI; 0.25-0.58; P<0.00001, I2 = 9%. All studies were included for evaluation of safety, with a total of 8 adverse events reported overall (4 in the experimental group and 4 in the control group.The systematic review and meta-analysis indicated that aprotinin, TXA, and EACA all significantly reduced perioperative blood loss and transfusion requirements

  16. Myoclonus, Seizure, and Ventricular Fibrillation after Intrathecal Injection of Tranexamic Acid

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    Abdolhamid Zokai

    2009-12-01

    Full Text Available Tranexamic acid is generally used in the treatment of disorders that predispose one to bleeding. It is a synthetic lysine analog that has strong antifibrinolytic activity. Plasminogen binds to fibrin to form plasmin, which in turn degrades fibrin into fibrin degradation products. Tranexamic acid blocks the lysine binding site on plasminogen and prevents interaction with fibrin. Tranexamic acid reduces blood loss in open heart surgery, hip replacement, and gynecology procedures. In this first case of inadvertent intrathecal injection of Tranexamic acid in a pregnant woman, we found that a massive intrathecal injection of Tranexamic acid triggered refractory ventricular fibrillation and cardiovascular collapse, which did not respond to full resuscitation.

  17. Tranexamic acid reduces blood loss during and after cesarean section:A double blinded, randomized, controlled trial

    Institute of Scientific and Technical Information of China (English)

    Amr H Yehia; Magdy H Koleib; Ibrahim A Abdelazim; Ahmed Atik

    2014-01-01

    Objective:To evaluate the efficacy of tranexamic acid in reduction of blood loss during and after cesarean section.Methods:Women included in the current double blinded, randomized, controlled trial were recruited from women attending for elective cesarean section and randomized into two groups; study group: received tranexamic acid with induction of anesthesia plus10IU of oxytocin injection after delivery of the baby.Control group: received only oxytocin 10IU injection after delivery of the baby.Results:Twenty four hours post-operative hemoglobin level was significantly higher in study group(11.2±1.5 mg/dL) compared to control(9.6±1.2 mg/dL), also24 hours post-operative hematocrit was significantly higher in study group(30.2±6.6) compared to control(29.2±2.8).Calculated total blood loss from placental delivery till end of cesarean section was significantly less in study group compared to control(369.5±198.0 versus606.8±193.0 mL; respectively), also, calculated vaginal bleeding during first6 hours post-operative was significantly less in study group compared to control(85.0±30.7 mL versus130.8±49.3 mL, respectively).The incidence of post-partum hemorrhage was significantly less in study group compared to control(31.1% versus63.2%; respectively), also the need for iron replacement therapy was significantly less frequent in study group compared to control(0.9% versus6.6%, respectively). Conclusions:Tranexamic acid can be used safely to reduce blood loss during cesarean section. Reduced blood loss after tranexamic acid was associated with improvement of post-operative hemoglobin, hematocrit and with reduction of post-partum need for iron replacement.

  18. Topical tranexamic acid as a novel treatment for bleeding peptic ulcer: A randomised controlled trial

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    Mandana Rafeey

    2016-01-01

    Full Text Available Background: Peptic ulcers are among the most common causes of upper gastrointestinal (GI bleeding in children. The standard care for GI bleeding is endoscopy for diagnostic and therapeutic purposes. We aimed to assess the effect of topical tranexamic acid (TXA via endoscopic procedures in children with GI bleeding caused by bleeding ulcers. Procedure: In this randomised controlled trial, 120 children were evaluated by diagnostic procedures for GI bleeding, of which 63 (30 girls, 33 boys aged 1-month to 15 years were recruited. The patients were randomly divided into case and control groups. In the case group, TXA was administered directly under endoscopic therapy. In the control group, epinephrine (1/10,000 was submucosally injected to the four quadrants of ulcer margins as the routine endoscopic therapy. In both groups, the patients received supportive medical therapy with intravenous fluids and proton pump inhibitor drugs. Results: The mean ± standard deviation age of the children was 5 ± 2.03 years. Rebleeding occurred in 15 (11.4% and 21 (9.8% patients in the case and control groups, respectively (P = 0.50. The frequency of blood transfusion episodes (P = 0.06 and duration of hospital stay (P = 0.07 were not statistically different between the groups. Conclusion: Using topical TXA via endoscopic procedures may be effective in cases of GI bleedings caused by active bleeding ulcers. In order to establish this therapeutic effect, a large number of clinical studies are needed.

  19. Tranexamic Acid in Anesthetic Management of Surgical Procedures.

    Science.gov (United States)

    Mayeux, Jessica; Alwon, Kathy; Collins, Shawn; Hewer, Ian

    2016-06-01

    Blood loss during surgical procedures poses a grave risk to the patient, but transfusion is costly and associated with adverse outcomes. Antifibrinolytics, however, offer an economical and effective means of decreasing blood loss associated with surgical procedures. Tranexamic acid (TXA) is an antifibrinolytic that blocks lysine-binding sites of fibrinogen and fibrin, preventing the breakdown of existing clots. This journal course reviews extensive research demonstrating that antifibrinolytics such as TXA decrease blood loss and in some studies reduce allogeneic transfusion requirements. In addition, this journal course addresses concerns that use of antifibrinolytics increases embolic events, reviews research that demonstrates TXA does not increase the incidence of vascular occlusive events, and describes methods of TXA use in cardiac and orthopedic surgical procedures, neurosurgery, and obstetrics. The Certified Registered Nurse Anesthetist should consider the possibility, on a case-by-case basis, of using TXA in surgical procedures to reduce blood loss with minimal adverse effects. PMID:27501656

  20. Safety and Effectiveness of two treatment regimes with tranexamic acid to minimize inflammatory response in elective cardiopulmonary bypass patients: a randomized double-blind, dose-dependent, phase IV clinical trial

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    Martín Beatriz

    2011-10-01

    Full Text Available Abstract Background In cardiopulmonary bypass (CPB patients, fibrinolysis may enhance postoperative inflammatory response. We aimed to determine whether an additional postoperative dose of antifibrinolytic tranexamic acid (TA reduced CPB-mediated inflammatory response (IR. Methods We performed a randomized, double-blind, dose-dependent, parallel-groups study of elective CPB patients receiving TA. Patients were randomly assigned to either the single-dose group (40 mg/Kg TA before CPB and placebo after CPB or the double-dose group (40 mg/Kg TA before and after CPB. Results 160 patients were included, 80 in each group. The incident rate of IR was significantly lower in the double-dose-group TA2 (7.5% vs. 18.8% in the single-dose group TA1; P = 0.030. After adjusting for hypertension, total protamine dose and temperature after CPB, TA2 showed a lower risk of IR compared with TA1 [OR: 0.29 (95% CI: 0.10-0.83, (P = 0.013]. Relative risk for IR was 2.5 for TA1 (95% CI: 1.02 to 6.12. The double-dose group had significantly lower chest tube bleeding at 24 hours [671 (95% CI 549-793 vs. 826 (95% CI 704-949 mL; P = 0.01 corrected-P significant] and lower D-dimer levels at 24 hours [489 (95% CI 437-540 vs. 621(95% CI: 563-679 ng/mL; P = 0.01 corrected-P significant]. TA2 required lower levels of norepinephrine at 24 h [0.06 (95% CI: 0.03-0.09 vs. 0.20(95 CI: 0.05-0.35 after adjusting for dobutamine [F = 6.6; P = 0.014 corrected-P significant]. We found a significant direct relationship between IL-6 and temperature (rho = 0.26; P P P P P P P Conclusions Prolonged inhibition of fibrinolysis, using an additional postoperative dose of tranexamic acid reduces inflammatory response and postoperative bleeding (but not transfusion requirements in CPB patients. A question which remains unanswered is whether the dose used was ideal in terms of safety, but not in terms of effectiveness. Current Controlled Trials number ISRCTN: ISRCTN84413719

  1. Use of intravenous tranexamic acid in total knee arthroplasty: a meta-analysis of randomized controlled trials

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    FU De-jie

    2013-04-01

    Full Text Available 【Abstract】 Objective: The effect of tranexamic acid (TA on patients receiving total knee arthroplasty (TKA has been reported in many small clinical trials. But single trials are not sufficient enough to clarify the effectiveness and safety of TA. So, we carried out a meta-analysis of randomized controlled trials to investigate the efficacy and safety of the intravenous use of TA in TKA. Methods: Literatures were retrieved in Cochrane Library, OVID, PubMed, EMBASE, CNKI and Wanfang Data. All the related literatures were checked by two independent investigators and only the high quality randomized con-trolled trials were enrolled. Relevant data were analyzed using RevMan 5.1 to compare the difference of blood loss, transfusion and complications between TA group and con-trol group. Results: There were 353 related literatures and only 22 randomized controlled trials met the inclusion criteria. The use of TA in TKA significantly reduced total blood loss by a mean of 435.41 ml (95% CI 300.62-570.21, P<0.01, post-operative blood loss by a mean of 406.69 ml (95% CI 333.16-480.22, P<0.01. TA also significantly lowered the transfu-sion rate (risk difference 0.30, 95% CI 0.21-0.39, P<0.01 and transfusion volume (mean difference 0.95 unit, 95% CI 0.53-1.37, P<0.01. The risks between TA group and control group in developing deep vein thrombosis and pulmonary embo-lism were not statistically significant. Conclusion: TA is beneficial for patients undergoing TKA, which can significantly reduce total blood loss, post-operative blood loss, transfusion rate, and transfusion volume. Meanwhile TA is recommended to reduce deep vein thrombosis and pulmonary embolism following TKA. Key words: Tranexamic acid; Arthroplasty; Knee; Blood loss, surgical; Meta-analysis

  2. Accidental Intrathecal Injection of Tranexamic Acid

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    Khaled Mahmoud

    2012-01-01

    Full Text Available Tranexamic acid (TXA is a popular antifibrinolytic drug that is commonly used in patients with bleeding disorder. Major morbidities and mortalities have been reported following inadvertent intrathecal injection of TXA. In this paper, inadvertent intrathecal injection of TXA has resulted from similarities in appearance between TXA and heavy bupivacaine 0.5% ampoules. The patient experienced severe pain in the back and gluteal region upon injection in association with systemic hypertension and tachycardia followed by generalized myoclonic seizures and ventricular fibrillation.

  3. Use of intravenous tranexamic acid in total knee arthroplasty: a meta-analysis of randomized controlled trials

    Institute of Scientific and Technical Information of China (English)

    FU De-jie; CHEN Cheng; GUO Lin; YANG Liu

    2013-01-01

    Objective:The effect of tranexamic acid (TA) on patients receiving total knee arthroplasty (TKA) has been reported in many small clinical trials.But single trials are not sufficient enough to clarify the effectiveness and safety of TA.So,we carried out a meta-analysis of randomized controlled trials to investigate the efficacy and safety of the intravenous use of TA in TKA.Methods:Literatures were retrieved in Cochrane Library,OVID,PubMed,EMBASE,CNKI and Wanfang Data.All the related literatures were checked by two independent investigators and only the high quality randomized controlled trials were enrolled.Relevant data were analyzed using RevMan 5.1 to compare the difference of blood loss,transfusion and complications between TA group and control group.Results:There were 353 related literatures and only 22 randomized controlled trials met the inclusion criteria.The use of TA in TKA significantly reduced total blood loss by a mean of 435.41 ml (95% CI300.62-570.21,P<0.01),postoperative blood loss by a mean of 406.69 ml (95% CI333.16-480.22,P<0.01).TA also significantly lowered the transfusion rate (risk difference 0.30,95% CI0.21-0.39,P<0.01) and transfusion volume (mean difference 0.95 unit,95% CI0.53-1.37,P<0.01).The risks between TA group and control group in developing deep vein thrombosis and pulmonary embolism were not statistically significant.Conclusion:TA is beneficial for patients undergoing TKA,which can significantly reduce total blood loss,postoperative blood loss,transfusion rate,and transfusion volume.Meanwhile TA is recommended to reduce deep vein thrombosis and pulmonary embolism following TKA.

  4. Simple, rapid, and sensitive liquid chromatography-fluorescence method for the quantification of tranexamic acid in blood

    NARCIS (Netherlands)

    J.F. Huertas-Perez; M. Heger; H. Dekker; H. Krabbe; J. Lankelma; F. Ariese

    2007-01-01

    Tranexamic acid (TA) is a synthetic antifibrinolytic agent that is being considered as a candidate adjuvant drug for site-specific pharmaco-laser therapy of port wine stains. For drug utility studies, a high-performance liquid chromatography (HPLC)-fluorescence method was developed for the quantific

  5. Systematic review: tranexamic acid for upper gastrointestinal bleeding

    DEFF Research Database (Denmark)

    Klingenberg, S.L.; Langholz, S.E.; Gluud, Lise Lotte

    2008-01-01

    were unclearly reported. Data from three of the included trials suggested that tranexamic acid did not significantly increase the risk of thromboembolic disease. CONCLUSIONS: The present review suggests that tranexamic acid may reduce all-cause mortality. However, because of limitations in the internal...

  6. Efficacy and safety of antifibrinolytic drugs in liver transplantation : A systematic review and meta-analysis

    NARCIS (Netherlands)

    Molenaar, I. Q.; Warnaar, N.; Groen, H.; TenVergert, E. M.; Slooff, M. J. H.; Porte, R. J.

    2007-01-01

    Although several randomized controlled trials (RCTs) have shown the efficacy of antifibrinolytic drugs in liver transplantation, their use remains debated due to concern for thromboembolic complications. None of the reported RCTs has shown a higher incidence of these complications in treated patient

  7. Safety and efficacy of tranexamic acid in bleeding paediatric trauma patients: a systematic review protocol

    Science.gov (United States)

    Urban, Denisa; Dehaeck, Ruben; Lorenzetti, Diane; Guilfoyle, Jonathan; Poon, Man-Chiu; Steele, MacGregor; Lardner, David; Ma, Irene Wai Yan; Brindle, Mary Elizabeth

    2016-01-01

    Introduction Trauma is the leading cause of death among children aged 1–18. Studies indicate that better control of bleeding could potentially prevent 10–20% of trauma-related deaths. The antifibrinolytic agent tranexamic acid (TxA) has shown promise in haemorrhage control in adult trauma patients. However, information on the potential benefits of TxA in children remains sparse. This review proposes to evaluate the current uses, benefits and adverse effects of TxA in the bleeding paediatric trauma population. Methods and analysis A structured search of bibliographic databases (eg, MEDLINE, EMBASE, PubMed, CINAHL, Cochrane CENTRAL) has been undertaken to retrieve randomised controlled trials and cohort studies that describe the use of TxA in paediatric trauma patients. To ensure that all relevant data were captured, the search did not contain any restrictions on language or publication time. After deduplication, citations will be screened independently by 2 authors, and selected for inclusion based on prespecified criteria. Data extraction and risk of bias assessment will be performed independently and in duplicate. Meta-analytic methods will be employed wherever appropriate. Ethics and dissemination This study will not involve primary data collection, and formal ethical approval will therefore not be required. The findings of this study will be disseminated through a peer-reviewed publication and at relevant conference meetings. Trial registration number CRD42016038023. PMID:27660323

  8. Effect of antifibrinolytic drugs on transfusion requirement and blood loss during orthotopic liver transplantation: Results from a single center

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    Devi A

    2008-01-01

    Full Text Available Background: During orthotopic liver transplantation (OLT, activation of the fibrinolytic system can contribute significantly to perioperative bleeding. Prophylactic administration of antifibrinolytic agents has been shown to reduce blood loss and the need for allogenic transfusion. Objective: To study the effect of antifibrinolytics on requirement of blood components, blood loss and operative time during OLT in patients with end stage liver disease, reporting to a single centre. Materials and Methods: Consecutive patients who underwent OLT at this centre during the period February 2003-October 2007 were the subjects of this study. Based on the individual anesthesiologist′s preference, patients were assigned to receive either two million units of aprotinin (AP as a bolus followed by 5,00,000 units/hour or 10 mg/kg tranexamic acid (TAas a bolus followed by 10 mg/kg every six to eight hours, administered from the induction till the end of the surgery. Transfusion policy was standardized in all patients. Intraoperative red cell salvage was done wherever possible. The effect of these two antifibrinolytic drugs on transfusion requirement was evaluated as a whole and in a sub group of patients from each treatment group and compared with a concurrent control group that did not receive antifibrinolytic drugs. Results: Fifty patients (40 M / 10 F, 44 adults, 6 pediatric patients underwent OLT in the study period. Fourteen patients were given AP, 25 patients were given TA and 11 patients did not receive any of the agents(control group. The median volume of total blood components transfused in antifibrinolytic group (n=39 was 4540 ml(0-19,200ml, blood loss 5 l(0.7-35l and operative time 9h (4.5-17h and that of control group(n=11 was 5700 ml(0-15,500ml, 10 l(0.6-25 l and 9h (6.4-15.8h respectively. The median volume of blood transfusions, blood loss and operative time was lesser in AP group(n=14 than that of TA group(n=25. Conclusion: There is definite

  9. Efficacy of tranexamic acid as compared to aprotinin in open heart surgery in children

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    Nagarajan Muthialu

    2015-01-01

    Full Text Available Background: Coagulopathy is a major issue in children undergoing high-risk pediatric cardiac surgery. Use of anti-fibrinolytics is well documented in adults, but recently there are questions raised about safety and effectiveness of their use on routine use. Tranexamic acid is a potent anti-fibrinolytic, but its role is not fully understood in children. This study aims to study the benefits tranexamic acid in controlling postoperative bleeding in pediatric cardiac surgical patients. Methods and Results: Fifty consecutive children who underwent cardiac surgery were randomized prospectively to receive either aprotinin (Group A; n = 24 or tranexamic acid (Group B; n = 26 from September 2009 to February 2010 were studied. Primary end points were early mortality, postoperative drainage, reoperation for bleeding and complications. Mean age and body weight was smaller in Group A (Age: 48.55 vs. 64.73 months; weight 10.75 vs. 14.80 kg respectively. Group A had more cyanotic heart disease than Group B (87.5% vs. 76.92%. Mean cardiopulmonary bypass time (144.33 vs. 84.34 min and aortic cross-clamp time (78.5 vs. 41.46 min were significantly higher in group A. While the blood and products usage was significantly higher in Group A, there was no difference in indexed postoperative drainage in first 4, 8 and 12 h and postoperative coagulation parameters. Mean C-reactive protein was less in Group A than B and renal dysfunction was seen more in Group A (25% vs. 7.6%. Mortality in Group A was 16.66% and 7.6% in Group B. Conclusion: Anti-fibrinolytics have a definitive role in high-risk children who undergo open-heart surgery. Tranexamic acid is as equally effective as aprotinin with no additional increase in morbidity or mortality. Ultramini Abstract: Coagulopathy has been a major issue in pediatric cardiac surgery, and anti-fibrinolytics have been used fairly regularly in various settings. This study aims to evaluate the efficacy of tranexamic acid as compared

  10. Preventive and therapeutic effects of tranexamic acid on postpartum bleeding

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    Samaneh Solltani

    2014-12-01

    Full Text Available Postpartum hemorrhage is among the leading causes of maternal mortality throughout the world. Severe blood loss contributes to  the increased blood transfusion risk with its concerned inherent adverse events and therefore increased rate of emergency re-operative interventions such as arterial ligation or hysterectomy. It also can lead to protracted anemia, particularly in low or median income countries. Extended application of antifibrinolytic agents such as tranexamic acid has been customary for long years to stop or reduce blood loss in postpartum period. However, there are not enough reliable evidence to approve the real efficacy of these drugs. In this brief and summary review, we pointed to a few conducted studies. The PubMed was searched for keyword including postpartum hemorrhage, tranexamic acid, cesarean section, vaginal delivery, and blood loss prevention. The articles with language other than English were excluded from our review.  We concluded that more convincing information is needed to determine the precise effects of tranexamic acid, and its benefits against adverse effects.

  11. Low Dose Perioperative Intravenous Tranexamic Acid in Patients Undergoing Total Knee Arthroplasty: A Double-Blind Randomized Placebo Controlled Clinical Trial

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    Mahdi Motififard

    2015-01-01

    Full Text Available Background and Objectives. The null hypothesis of this study was that TA has no effect on postsurgical bleeding in patients undergoing TKA. Methods. This study was a double-blind randomized trial. In the first group (T patients received 500 mg of intravenous Tranexamic acid (TA twice (once preoperatively and once 3 hours postoperatively and in the second group (P they received slow infusion of normal saline as placebo. The primary outcome of the study was the level of Hb 48 hours after surgery. Results. Hb levels 48 hours after surgery as the primary outcome were 10.92±0.97 and 10.23±0.98 (g/dL in groups T and P, respectively, and the difference was statistically significant (P=0.001. Statistically significant differences were also observed in Hb levels 6 and 24 hours after surgery, the drain output 48 hours after surgery, and the number of units of packed cells transfused between study groups (P<0.05. There was no significant difference in duration of hospitalization between the study groups (P = n.s.. Conclusions. The low dose perioperative intravenous TA significantly reduces blood loss, requirement for blood transfusion, and drain output in patients undergoing TKA. However, duration of hospitalization did not change significantly.

  12. Use of tranexamic acid for controlling bleeding in thoracolumbar scoliosis surgery with posterior instrumentation

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    Vinícius Magno da Rocha

    2015-04-01

    Full Text Available OBJECTIVE: Scoliosis surgery involves major blood loss and frequently requires blood transfusion. The cost and risks involved in using allogeneic blood have motivated investigation of methods capable of reducing patients' bleeding during operations. One of these methods is to use antifibrinolytic drugs, and tranexamic acid is among these. The aim of this study was to assess the use of this drug for controlling bleeding in surgery to treat idiopathic scoliosis.METHODS: This was a retrospective study in which the medical files of 40 patients who underwent thoracolumbar arthrodesis by means of a posterior route were analyzed. Of these cases, 21 used tranexamic acid and were placed in the test group. The others were placed in the control group. The mean volumes of bleeding during and after the operation and the need for blood transfusion were compared between the two groups.RESULTS: The group that used tranexamic acid had significantly less bleeding during the operation than the control group. There was no significant difference between the groups regarding postoperative bleeding and the need for blood transfusion.CONCLUSIONS: Tranexamic acid was effective in reducing bleeding during the operation, as demonstrated in other studies. The correlation between its use and the reduction in the need for blood transfusion is multifactorial and could not be established in this study. We believe that tranexamic acid may be a useful resource and that it deserves greater attention in randomized double-blind prospective series, with proper control over variables that directly influence blood loss.

  13. Which Route of Tranexamic Acid Administration is More Effective to Reduce Blood Loss Following Total Knee Arthroplasty?

    Science.gov (United States)

    Keyhani, Sohrab; Esmailiejah, Ali Akbar; Abbasian, Mohammad Reza; Safdari, Farshad

    2016-01-01

    Background: The most appropriate route of tranexamic acid administration is controversial. In the current study, we compared the efficacy of intravenous (IV) and topical intra-articular tranexamic acid in reducing blood loss and transfusion rate in patients who underwent primary total knee arthroplasty. Methods: One hundred twenty 120 patients were scheduled to undergo primary total knee arthroplasty. Patients were randomly allocated to three equal groups: IV tranexamic acid (500 mg), topical tranexamic acid (3 g in 100 mL normal saline) and the control. In the topical group, half of the volume was used to irrigate the joint and the other half was injected intra-articularly. The volume of blood loss, hemoglobin (Hb) level at 24 hours postoperative, and rate of transfusion was compared between groups. Results: The blood loss and Hb level were significantly greater and lower in the control group, respectively (P=0.031). Also, the rate of transfusion was significantly greater in the control group (P=0.013). However, IV and topical groups did not differ significantly in terms of measured variables. No patient experienced a thromboembolic event in our study. Conclusion: Tranexamic acid is a useful antifibrinolytic drug to reduce postoperative blood loss, Hb drop, and rate of blood transfusion in patients undergoing total knee arthroplasty. The route of tranexamic acid administration did not affect the efficacy and safety. PMID:26894222

  14. A randomized trial of the effect of low dose epinephrine infusion in addition to tranexamic acid on blood loss during total hip arthroplasty

    DEFF Research Database (Denmark)

    Jans, Ø; Grevstad, Jens Ulrik; Mandøe, H;

    2016-01-01

    procedure. Intraoperative tranexamic acid (TXA) was administered to all subjects. The primary outcome was intraoperative blood loss directly measured by drains and weighing swabs. Secondary outcome was total blood loss at 24 h postoperatively calculated using the Gross formula. RESULTS: Of 106 subjects...

  15. A prospective, randomized, double-blinded single-site control study comparing blood loss prevention of tranexamic acid (TXA to epsilon aminocaproic acid (EACA for corrective spinal surgery

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    Vaz Kenneth M

    2010-04-01

    Full Text Available Abstract Background Multilevel spinal fusion surgery has typically been associated with significant blood loss. To limit both the need for transfusions and co-morbidities associated with blood loss, the use of anti-fibrinolytic agents has been proposed. While there is some literature comparing the effectiveness of tranexamic acid (TXA to epsilon aminocaproic acid (EACA in cardiac procedures, there is currently no literature directly comparing TXA to EACA in orthopedic surgery. Methods/Design Here we propose a prospective, randomized, double-blinded control study evaluating the effects of TXA, EACA, and placebo for treatment of adolescent idiopathic scoliosis (AIS, neuromuscular scoliosis (NMS, and adult deformity (AD via corrective spinal surgery. Efficacy will be determined by intraoperative and postoperative blood loss. Other clinical outcomes that will be compared include transfusion rates, preoperative and postoperative hemodynamic values, and length of hospital stay after the procedure. Discussion The primary goal of the study is to determine perioperative blood loss as a measure of the efficacy of TXA, EACA, and placebo. Based on current literature and the mechanism by which the medications act, we hypothesize that TXA will be more effective at reducing blood loss than EACA or placebo and result in improved patient outcomes. Trial Registration ClinicalTrials.gov ID: NCT00958581

  16. The combined effect of administration of intravenous and topical tranexamic acid on blood loss and transfusion rate in total knee arthroplasty

    Science.gov (United States)

    Yuan, Z. F.; Yin, H.; Xing, D. L.

    2016-01-01

    Objectives Tranexamic acid (TXA) is an antifibrinolytic agent used as a blood-sparing technique in total knee arthroplasty (TKA), and is routinely administered by intravenous (IV) or intra-articular (IA) injection. Recently, a novel method of TXA administration, the combined IV and IA application of TXA, has been applied in TKA. However, the scientific evidence of combined administration of TXA in TKA is still meagre. This meta-analysis aimed to investigate the efficacy and safety of combined IV and IA TXA in patients undergoing TKA. Materials and Methods A systematic search was carried out in PubMed, the Cochrane Clinical Trial Register (Issue12 2015), Embase, Web of Science and the Chinese Biomedical Database. Only randomised controlled trials (RCT) evaluating the efficacy and safety of combined use TXA in TKA were identified. Two authors independently identified the eligible studies, extracted data and assessed the methodological quality of included studies. Meta-analysis was conducted using Review Manager 5.3 software. Results A total of ten RCTs (1143 patients) were included in this study. All the included studies were randomised and the quality of included studies still needed improvement. The results indicated that, compared with either placebo or the single-dose TXA (IV or IA) group, the combination of IV and IA TXA group had significantly less total blood loss, hidden blood loss, total drain output, a lower transfusion rate and a lower drop in haemoglobin level. There were no statistically significant differences in complications such as wound infection and deep vein thrombosis between the combination group and the placebo or single-dose TXA group. Conclusions Compared with placebo or the single-dose TXA, the combined use of IV and IA TXA provided significantly better results with respect to all outcomes related to post-operative blood loss without increasing the risk of thromboembolic complications in TKA. Cite this article: Z. F. Yuan, H. Yin, W. P. Ma

  17. Systematic review and meta-analysis of perioperative intravenous tranexamic acid use in spinal surgery.

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    Baohui Yang

    Full Text Available BACKGROUND: Tranexamic acid (TXA is well-established as a versatile oral, intramuscular, and intravenous (IV antifibrinolytic agent. However, the efficacy of IV TXA in reducing perioperative blood transfusion in spinal surgery is poorly documented. METHODOLOGY: We conducted a meta-analysis of randomized controlled trials (RCTs and quasi-randomized (qi-RCTs trials that included patients for various spinal surgeries, such as adolescent scoliosis surgery administered with perioperative IV TXA according to Cochrane Collaboration guidelines using electronic PubMed, Cochrane Central Register of Controlled Trials, and Embase databases. Additional journal articles and conference proceedings were manually located by two independent researchers. RESULTS: Totally, nine studies were included, with a total sample size of 581 patients. Mean blood loss was decreased in patients treated with perioperative IV TXA by 128.28 ml intraoperatively (ranging from 33.84 to 222.73 ml, 98.49 ml postoperatively (ranging from 83.22 to 113.77 ml, and 389.21 ml combined (ranging from 177.83 to 600.60 ml. The mean volume of transfused packed cells were reduced by 134.55 ml (ranging 51.64 to 217.46 (95% CI; P = 0.0001. Overall, the number of patients treated with TXA who required blood transfusions was lower by 35% than that of patients treated with the comparator and who required blood transfusions (RR 0.65; 95% CI; 0.53 to 0.85; P<0.0001, I(2 = 0%. A dose-independent beneficial effect of TXA was observed, and confirmed in subgroup and sensitivity analyses. A total of seven studies reported DVT data. The study containing only a single DVT case was not combined. CONCLUSIONS: The blood loss was reduced in spinal surgery patients with perioperative IV TXA treatment. Also the percentage of spinal surgery patients who required blood transfusion was significantly decreased. Further evaluation is required to confirm our findings before TXA can be safely used in patients

  18. Tranexamic acid in surgical treatment of scoliosis in children: A case report

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    Rakić Goran

    2016-01-01

    Full Text Available Introduction. Children who are subjected to surgical treatment for scoliosis usually end up receiving a lot of blood transfusions since they tend to lose one or more blood volumes during the surgery. Tranexamic acid is an antifibrinolytic agent, increasingly used in children to reduce perioperative blood loss in various settings, including corrective surgery of scoliosis. Case Report. A 12-year-old girl, weighing 44 kg, was admitted to our hospital for scoliosis correction. She had congenital scoliosis caused by congenital malformation of vertebrae. The surgery was performed under balanced general anesthesia. Two central and one peripheral line were cannulated in case massive transfusion would be required. Invasive monitoring was used, as well as prevention of hypothermia. Since massive blood loss was expected, bolus of tranexamic acid had been administered prior to the surgery. Tranexamic acid was given continuously in an intravenous infusion during the surgery. Blood loss was only 10 ml/kg, and since the hemoglobin value was borderline (89 g/l during the surgery, the patient received 10 ml/kg of packed red blood cells. The child was hemodynamically stable throughout the surgery. After the completion of surgery, which lasted for 5 hours, the patient was extubated in the operating room. Postoperatively, the patient was transferred to the surgical ward. Hemoglobin values were stable and there was no need for additional blood replacement. Conclusion. Extensive blood loss is common in pediatric scoliosis correction surgery, transfusion being unavoidable in the majority of cases. In our patient, tranexamic acid proved safe and effective in reducing peri-operative blood loss and transfusion requirement.

  19. Use of antifibrinolytic mouthwash solution in anticoagulated oral surgery patients

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    Dimova, Cena; Evrosimovska, Biljana; Papakoca, Kiro; Georgiev, Zlatko; Angelovska, Bistra; Ristoska, Sonja

    2012-01-01

    Introduction:The ordinary treatment of anticoagulated patients includes the interruption of anticoagulant therapy for oral surgery interventions to prevent hemorrhage. However, this practice may logically increase the risk of a potentially life-threatening thromboembolism, so this issue is still controversial. The aim of the study was to evaluate the antifibrinolitic mouthwash solution (tranexamic acid) as a local haemostatic modality after oral surgery interventions. Methods:To realize the a...

  20. Efficacy of tranexamic acid in reducing blood loss in posterior lumbar spine surgery for degenerative spinal stenosis with instability: a retrospective case control study

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    Endres Stefan

    2011-11-01

    Full Text Available Abstract Background Degenerative spinal stenosis and instability requiring multilevel spine surgery has been associated with large blood losses. Factors that affect perioperative blood loss include time of surgery, surgical procedure, patient height, combined anterior/posterior approaches, number of levels fused, blood salvage techniques, and the use of anti-fibrinolytic medications. This study was done to evaluate the efficacy of tranexamic acid in reducing blood loss in spine surgery. Methods This retrospective case control study includes 97 patients who had to undergo surgery because of degenerative lumbar spinal stenosis and instability. All operations included spinal decompression, interbody fusion and posterior instrumentation (4-5 segments. Forty-six patients received 1 g tranexamic acid intravenous, preoperative and six hours and twelve hours postoperative; 51 patients without tranexamic acid administration were evaluated as a control group. Based on the records, the intra- and postoperative blood losses were measured by evaluating the drainage and cell saver systems 6, 12 and 24 hours post operation. Additionally, hemoglobin concentration and platelet concentration were reviewed. Furthermore, the number of red cell transfusions given and complications associated with tranexamic acid were assessed. Results The postoperative hemoglobin concentration demonstrated a statistically significant difference with a p value of 0.0130 showing superiority for tranexamic acid use (tranexamic acid group: 11.08 g/dl, SD: 1.68; control group: 10.29 g/dl, SD: 1.39. The intraoperative cell saver volume and drainage volume after 24 h demonstrated a significant difference as well, which indicates a less blood loss in the tranexamic acid group than the control group. The postoperative drainage volume at12 hours showed no significant differences; nor did the platelet concentration Allogenic blood transfusion (two red cell units was needed for eight patients

  1. Use of Tranexamic acid is a cost effective method in preventing blood loss during and after total knee replacement

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    Umer Chaudhry Muhammad

    2011-05-01

    Full Text Available Abstract Background & Purpose Allogenic blood transfusion in elective orthopaedic surgery is best avoided owing to its associated risks. Total knee replacement often requires blood transfusion, more so when bilateral surgery is performed. Many strategies are currently being employed to reduce the amount of peri-operative allogenic transfusions. Anti-fibrinolytic compounds such as aminocaproic acid and tranexamic acid have been used systemically in perioperative settings with promising results. This study aimed to evaluate the effectiveness of tranexamic acid in reducing allogenic blood transfusion in total knee replacement surgery. Methodology This was a retrospective cohort study conducted on patients undergoing total knee replacement during the time period November 2005 to November 2008. Study population was 99 patients, of which 70 underwent unilateral and 29 bilateral knee replacement. Forty-seven patients with 62 (49.5% knees (group-I had received tranexamic acid (by surgeon preference while the remaining fifty-two patients with 66 (51.5% knees (group-II had did not received any tranexamic acid either pre- or post-operatively. Results The mean drop in the post-operative haemoglobin concentration in Group-II for unilateral and bilateral cases was 1.79 gm/dl and 2.21 gm/dl, with a mean post-operative drainage of 1828 ml (unilateral and 2695 ml (bilateral. In comparison, the mean drop in the post-op haemoglobin in Group-I was 1.49 gm/dl (unilateral and 1.94 gm/dl (bilateral, with a mean drainage of 826 ml (unilateral and 1288 ml (bilateral (p-value Interpretation Tranexamic acid is effective in reducing post-operative drainage and requirement of blood transfusion after knee replacement.

  2. Blood Loss and Transfusion After Topical Tranexamic Acid Administration in Primary Total Knee Arthroplasty.

    Science.gov (United States)

    Wang, Hao; Shen, Bin; Zeng, Yi

    2015-11-01

    There has been much debate and controversy about the safety and efficacy of the topical use of tranexamic acid in primary total knee arthroplasty (TKA). The purpose of this study was to perform a meta-analysis to evaluate whether there is less blood loss and lower rates of transfusion after topical tranexamic acid administration in primary TKA. A systematic review of the electronic databases PubMed, CENTRAL, Web of Science, and Embase was undertaken. All randomized, controlled trials and prospective cohort studies evaluating the effectiveness of topical tranexamic acid during primary TKA were included. The focus of the analysis was on the outcomes of blood loss results, transfusion rate, and thromboembolic complications. Subgroup analysis was performed when possible. Of 387 studies identified, 16 comprising 1421 patients (1481 knees) were eligible for data extraction and meta-analysis. This study indicated that when compared with the control group, topical application of tranexamic acid significantly reduced total drain output (mean difference, -227.20; 95% confidence interval, -347.11 to -107.30; Pdeep venous thrombosis or pulmonary embolism due to tranexamic acid administration. Topical tranexamic acid was effective for reducing postoperative blood loss and transfusion requirements without increasing the prevalence of thromboembolic complications. PMID:26558665

  3. EFFECT OF TRANEXAMIC ACID IN CONTROL OF PERIOPERATIVE BLOOD LOSS ASSOCIATE WITH TOTAL KNEE REPLACEMENT OUR EXPERIENCE

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    Bhaskar

    2015-05-01

    Full Text Available BACKGROUND : Costs of allogenic blood transfusions and the associated risks mandate strategies to reduce blood loss in surgery. The objective of this study was to asse ss the efficacy of antifibrinolytic treatment in reducing perioperative blood loss during total knee replacement. MATERIALS AND METHOD S: A prospective study was carried out on 148patients undergoing total knee replacement. 88pts received tranexamic acid 10 mg kg −1 i.v. just before the cementation, 3hours post op and 6 hrs later.60 patients did not receive tranexamic acid. External perioperative blood loss was measured by post op amount of drain, and Hb levels and Hematocrit. The number of patients transfuse d and number of packed red cell (PRC units transfused was recorded and possible postoperative thrombo embolic complications were studied clinically. RESULTS : Amongst 78 pts who were given Cyclokapron, only 10(12.8% were given blood transfusions and the a verage transfusions were 3.9 units and Amongst 70 pts who were not given Cyclokapron, 20(28.5% were given blood transfusions and the average transfusions were 8.7 units. The average blood loss in the group of patients who were given cyclokapron was 1004ml while in the groups which were not given the average blood loss was 1507ml. Clinical assessment did not reveal any thromboembolic complications. CONCLUSIONS : Antifibrinolytic agents produce a significant decrease in blood loss in patients undergoing total knee replacement, reflected in a reduction in the number of blood transfusions required. Based on this study we can conclude that three doses of IV tranexamic acid of 10mg/kg, can be used in TKR procedures with proven effectiveness and efficiency to decre ase postoperative blood loss in patients undergoing TKR.

  4. Perioperative tranexamic acid in day-case paediatric tonsillectomy

    Science.gov (United States)

    Thorning, G

    2014-01-01

    Introduction Tranexamic acid has been used for many years to minimise blood loss during surgery and, more recently, to reduce morbidity after major trauma. While small studies have confirmed reduction in blood loss during tonsillectomy with its use, the rate of primary haemorrhage following tonsillectomy has not been reported. In the UK, less than 50% of children having a tonsillectomy are managed as day cases, partly because of concerns about bleeding during the initial 24 hours following surgery. Methods A retrospective review of clinical records between January 2007 and January 2013 produced 476 children between the ages of 3 and 16 years who underwent Coblation™ tonsillectomy, with or without adenoidectomy and/or insertion of ventilation tubes. All children were ASA (American Society of Anesthesiologists) grade 1 or 2 and anaesthetised using a standard day surgery protocol. Following induction of anaesthesia, all received intravenous tranexamic acid at a dose of 10–15mg/kg. Results Two children (0.4%) had minor bleeding within two hours of surgery. Both returned to theatre for haemostasis and were discharged home later the same day with no further complications. The expected rate for primary haemorrhage in the UK using this technique for tonsillectomy is 1%. Conclusions Perioperative tranexamic acid in a single, parenteral dose might reduce the incidence of primary haemorrhage following paediatric tonsillectomy, facilitating discharge on the day of surgery. The results from this observational study indicate a potential benefit and need for a large, prospective, multicentre, randomised controlled trial. PMID:24780670

  5. Combined Intra-Articular and Intravenous Tranexamic Acid Reduces Blood Loss in Total Knee Arthroplasty

    DEFF Research Database (Denmark)

    Nielsen, Christian Skovgaard; Jans, Øivind; Ørsnes, Thue;

    2016-01-01

    BACKGROUND: In total knee arthroplasty, both intravenous (IV) and intra-articular (IA) administration of tranexamic acid (TXA) have been shown to reduce blood loss in several randomized controlled trials, although routine use of systemic TXA is considerably more common. However, to our knowledge...

  6. 氨甲环酸治疗黄褐斑的研究进展%Tranexamic acid for the treatment of chloasma

    Institute of Scientific and Technical Information of China (English)

    粟倩雅; 林彤

    2015-01-01

    黄褐斑是一种常见的获得性色素增加性疾病,病因复杂,多种治疗方法均可改善黄褐斑,但疗效差及复发是临床常见的难题.氨甲环酸是一种抗纤溶药物,在临床上广泛用于治疗各种出血性疾病,近年来许多研究证实其治疗黄褐斑安全、有效.口服小剂量氨甲环酸治疗黄褐斑,可单独用药,或联合其他口服、外用药及激光治疗.用药时间的长短与疗效相关,一般用药1~2个月开始起效,治疗时间越长,疗效越好.静脉用药与口服药疗效无明显差别,但起效更快.氨甲环酸外用治疗黄褐斑与赋形剂无明显差异,局部微针和显微注射氨甲环酸有显著疗效,以前者疗效更佳.%Chloasma is a common acquired disorder of hyperpigmentation with complex etiology.Although there are many different therapies for chloasma,poor response and recurrence remain common clinical problems.Tranexamic acid,a kind of antifibrinolytic agent,is widely used to treat various kinds of hemorrhagic diseases.Many recent studies have proved it to be effective and safe in the treatment of chloasma.Small doses of oral tranexamic acid,alone or in combination with other oral medicines,externally applied drugs and lasers,can be used to treat chloasma.The therapeutic effect of tranexamic acid is related to the duration of medication treatment.The onset of action of tranexamic acid often takes 1 to 2 months,and the longer the treatment course,the better the outcome.Intravenous tranexamic acid does not differ from oral tranexamic acid in therapeutic effect,but the former shows a more rapid onset of action than the latter.There is no significant difference in efficacy for chloasma between topical tranexamic acid and vehicles,while microneedle injection of tranexamic acid exerts better efficacy than microinjection of it.

  7. A Comparison of aminocaproic Acid and Tranexamic Acid in Adult Cardiac Surgery.

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    Chauhan S

    2004-01-01

    Full Text Available We compared Aminocaproic acid with tranexamic acid, prospectively in 120 patients undergoing coronary artery bypass surgery on cardiopulmonary bypass. Patients were assigned to one of the 3 groups. Group A (n=40 did not receive any drug and acted as the control group. Group B (n=4 received aminocaproic acid 100 mg/kg each at anaesthetic induction, on bypass and after protamine reversal of heparin. group C (n=40 received tranexamic acid 10 mg/kg each at anaesthetic induction, on bypass and after protamine reversal of heparin. Postoperative blood loss at 24 hours, blood and blood product usage, and re-exploration rates were recorded, and tests for coagulation were performed at 6 hours postoperatively. It was found that blood loss in group A at 24 hours (780+/-120 mL was significantly greater than Group B (360+/-90 mL and Group C (215+/-70 mL. Plasma and platelet concentrate use in Group A (215+/-30 mL and 150+/-30 mL was greater than Group B (190+/-20 mL and 75+/-30 mL and Group C (185+/-20 mL and 80+/-30 mL. Re- explorations in Group A, 8/40 (20% were greater than Group B, 2/40 (5% and Group C, 2/40 (5%. Coagulation tests revealed better preservation of fibrinogen and lower levels of fibrin degradation products, in group B and C. These two groups were however statistically indistinguishable in respect to all the parameters studied, when compared with each other. It was concluded that both the antifibrinolytic agents in the doses studied were equally effective in reducing postoperative blood loss, blood and blood products usage and re-exploration rates. Coagulation parameters were better preserved as compared to the control group.

  8. Comparison of topical use of protamine and tranexamic acid in surgical patients requiring cardio-pulmonary bypass

    International Nuclear Information System (INIS)

    To determine the effectiveness of local protamine in reducing post-operative blood loss compared to local tranexamic acid. Study Design: Randomized controlled trial. Place and Duration of Study: Armed Forces Institute of Cardiology/National Institute of Heart Diseases Rawalpindi from January 2011 to September 2011. Patients and Methods: One hundred and twenty cardiac surgical patients were randomly divided into two equal groups, one receiving local protamine while the other group receiving local tranexamic acid before chest closure. The efficiency was measured as post-operative blood loss and requirement of blood and blood products in the post-surgical ICU. Results: Average blood loss in protamine group was significantly less (252.97 ml) compared to tranexamic acid group (680.67 ml). Number of patients requiring no post-operative blood transfusion was significantly higher in protamine group (76.7%) compared to tranexamic acid group (53.3%). Conclusion: Local protamine is more effective in reducing post-operative blood loss than local tranexamic acid. (author)

  9. Medication error: Subarachnoid injection of tranexamic acid

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    Bina P Butala

    2012-01-01

    Full Text Available Some factors have been identified as contributing to medical errors, such as labels, appearance and location of ampoules. We present a case of accidental injection of tranexamic acid instead of Bupivacaine during spinal anaesthesia. One minute after the injection of 3 mL of the solution, the patient developed myoclonus of her lower extremities. Accidental intrathecal injection of the wrong drug was suspected and a used ampoule of tranexamic acid was discovered in the trash can. The ampoules of Bupivacaine (5 mg/mL, trade name "Sensovac Heavy" and tranexamic acid (500 mg/mL, Trade name "Nexamin" were similar in appearance. Her myoclonus was successfully treated with phenytoin, sodium valproate, thiopental sodium infusion, midazolam infusion and supportive care of haemodynamic and respiratory systems. The surgery was temporarily deferred. The patient′s condition progressively improved to full recovery.

  10. 氨甲环酸对创伤患者死亡率、血管栓塞性并发症和输血量的影响:随机对照研究(全译)%Effects of tranexamic acid on mortality, vascular occlusive events and blood transfusion in trauma patients with significant haemorrhage (CRASH-2) : a randomized, placebo-controlled trial

    Institute of Scientific and Technical Information of China (English)

    CRASH-2研究组

    2011-01-01

    目的 基于氨甲环酸可以减少择期手术患者出血量的研究基础,观察早期快速静脉注射氨甲环酸对创伤患者死亡率、血管栓塞性并发症和输血量的影响. 方法 根据随机对照原则设计,在40个国家的274所医院实施,共纳入20211例严重出血或者有严重出血危险的成年患者.于伤后8h内,随机接受氨甲环酸(10 min内静脉注射1g,8h内静脉滴注1 g)或安慰剂治疗.投药序列中药物或安慰剂的选择由计算机自动生成.患者或研究者均不了解其真实情况.预后的主要评价指标是患者伤后4周的死亡率.死亡原因评价包括出血、血管栓塞性事件(心肌梗死、卒中、肺栓塞)、多器官功能衰竭、脑外伤及其他原因.本研究注册号为ISRCTN86750102. 结果 10096例患者接受氨甲环酸治疗,10115例患者接受安慰剂注射,两组分别有10060例和10067例患者资料接受进一步分析.药物组患者的总死亡率明显低于安慰剂组,即药物组1463例(14.5%),安慰剂组1613例(16.0%),相对危险度为0.91(95%CI为0.85~0.97,P=0.003 5).因出血导致的患者死亡率明显降低,药物组489例(4.9%),安慰剂组574例(5.7%),相对危险度0.85(95%CI为0.76~0.96,P=0.007 7). 结论 氨甲环酸可以安全地降低创伤出血患者的死亡率.本研究结果支持在创伤出血患者中使用氨甲环酸.%Objective To assess the effects of early administration of a short course of tranexamic acid on mortality,vascular occlusive events,and blood transfusion in trauma patients.Methods The randomized controlled trial was undertaken in 274 hospitals in 40 countries.A total of 20 211 adult trauma patients with,or at risk of,significant bleeding were randomly assigned within 8 hours of injury to either tranexamic acid ( intravenous injection of 1 g within 10 minutes after injury and intravenous infusion of 1 g within 8 hours after injury) or matching placebo.The dosing sequence in the choice of

  11. Uterine Balloon Tamponade in Combination with Topical Administration of Tranexamic Acid for Management of Postpartum Hemorrhage

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    Masato Kinugasa

    2015-01-01

    Full Text Available While uterine balloon tamponade is an effective modality for control of postpartum hemorrhage, the reported success rates have ranged from the level of 60% to the level of 80%. In unsuccessful cases, more invasive interventions are needed, including hysterectomy as a last resort. We developed a modified tamponade method and applied it to two cases of refractory postpartum hemorrhage after vaginal delivery. The first case was accompanied by uterine myoma and low-lying placenta. After an induced delivery, the patient had excessive hemorrhage due to uterine atony. Despite oxytocin infusion and bimanual uterine compression, the total blood loss was estimated at 2,800 mL or more. The second case was diagnosed as placental abruption complicated by fetal death and severe disseminated intravascular coagulation, subsequently. A profuse hemorrhage continued despite administration of uterotonics, fluid, and blood transfusion. The total blood loss was more than 5,000 mL. In each case, an intrauterine balloon catheter was wrapped in gauze impregnated with tranexamic acid, inserted into the uterus, and inflated sufficiently with sterile water. In this way, mechanical compression by a balloon and a topical antifibrinolytic agent were combined together. This method brought complete hemostasis and no further treatments were needed. Both the women left hospital in stable condition.

  12. Adsorption of tranexamic acid on hydroxyapatite: Toward the development of biomaterials with local hemostatic activity.

    Science.gov (United States)

    Sarda, Stéphanie; Errassifi, Farid; Marsan, Olivier; Geffre, Anne; Trumel, Catherine; Drouet, Christophe

    2016-09-01

    This work proposes to combine tranexamic acid (TAX), a clinically used antifibrinolytic agent, and hydroxyapatite (HA), widely used in bone replacement, to produce a novel bioactive apatitic biomaterial with intrinsic hemostatic properties. The aim of this study was to investigate adsorptive behavior of the TAX molecule onto HA and to point out its release in near physiological conditions. No other phase was observed by X-ray diffraction or transmission electron microscopy, and no apparent change in crystal size was detected. The presence of TAX on the powders was lightly detected on Raman spectra after adsorption. The adsorption data could be fitted with a Langmuir-Freundlich equation, suggesting a strong interaction between adsorbed molecules and the formation of multilayers. The concentration of calcium and phosphate ions in solution remained low and stable during the adsorption process, thus ion exchange during the adsorption process could be ruled out. The release of TAX was fast during the first hours and was governed by a complex process that likely involved both diffusion and dissolution of HA. Preliminary aPTT (activated partial thromboplastin time) hemostasis tests offered promising results for the development of osteoconductive apatitic biomaterials with intrinsic hemostatic properties, whether for dental or orthopedic applications. PMID:27207032

  13. Acute arterial thrombosis associated with inadvertent high dose of tranexamic acid

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    Surjya Prasad Upadhyay

    2013-01-01

    Full Text Available Tranexamic acid (TA act as anti-fibrinolytic agent and is widely used to limit bleeding in clinical practice. Tranexemic acid bind with plasminogen and prevent its conversion to plasmin, which limits the fibrinolytic pathway, so there is a theoretical risk of increasing thrombosis with high or prolonged therapy with TA. We encountered a case of acute arterial thrombosis following inadvertent administration of high dose of TA. A 27-years-old male with no other co-morbidity was ordered intravenous 1 gm TA to control excessive bleeding from previous bladder injury, but by mistake, he received 10 gm of TA. The patient developed signs and symptoms of acute ischemia in the right lower limb, which was diagnosed as acute iliac arterial thrombosis by computed tomography (CT angiography. The patient was managed with systemic heparinization, fasciotomy for impending gangrene and other supportive care following which he recovered fully within a few days. Caution should be exercised for all prophylactic use, especially with high dosage or prolonged therapy with TA.

  14. The effect of Tranexamic acid on cardiac surgery bleeding

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    Mohammad Esmaeelzadeh

    2014-02-01

    Full Text Available Serious bleeding in cardiac surgery leads to re-exploration, blood transfusion and increases the risks of mortality and morbidity. Using the lysine analogous of antifibrionlytic agents are the preferred strategy to suppress the need for transfusion procedures and blood products. Although tranexamic acid has been very influential in reducing the transfusion requirement after operation, tranexamic acid induced seizures is one of the common side effects of this drug. Due to inhibiting the fibrinolysis, thrombotic events are other possible side effects of using tranexamic acid. There are no certain results regarding decreasing the mortality rate by using the drug but it is identified that tranexamic acid does not increase the mortality. In this article, we aimed to review the literature on using tranexamic acid in cardiac surgeries.

  15. The effects of topically applied tranexamic acid on reduction of post-laminectomy hemorrhage

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    Saberi H

    2010-12-01

    Full Text Available "n Normal 0 false false false EN-US X-NONE AR-SA MicrosoftInternetExplorer4 /* Style Definitions */ table.MsoNormalTable {mso-style-name:"Table Normal"; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-priority:99; mso-style-qformat:yes; mso-style-parent:""; mso-padding-alt:0in 5.4pt 0in 5.4pt; mso-para-margin:0in; mso-para-margin-bottom:.0001pt; mso-pagination:widow-orphan; font-size:11.0pt; font-family:"Calibri","sans-serif"; mso-ascii-font-family:Calibri; mso-ascii-theme-font:minor-latin; mso-fareast-font-family:"Times New Roman"; mso-fareast-theme-font:minor-fareast; mso-hansi-font-family:Calibri; mso-hansi-theme-font:minor-latin; mso-bidi-font-family:Arial; mso-bidi-theme-font:minor-bidi;} Background: Topically applied tranexamic acid has been shown to decrease the amount of blood loss associated with major spinal surgical procedures. The aim of this study was to evaluate the effects of locally applied tranexamic acid in epidural space on post-laminectomy blood loss."n"nMethods: One hundred patients who were scheduled to undergo laminectomy in Imam Khomeini Hospital in Tehran, Iran were enrolled in a clinical trial. Patients were divided into two groups of unilateral one level (n=50 and bilateral two level (n=50 laminectomy according to the extent of surgery. Each group was randomly allocated into two groups of tranexamic acid (n=25 and control (n=25. At the end of the operation, 250mg tranexamic acid, with volume of 5ml or 5ml of normal saline were poured on the site of surgery. The blood volume drained during first and second 24hr, and overall hemorrhage, plus the duration of post operative hospitalization were compared between the two groups."n"nResults: The bleeding volume in the 1st 24hr was significantly less in tranexamic acid than control group (p=0.001. The bleeding volume in the 2nd 24hr was significantly less in tranexamic acid than control group (p=0.001. The hospital stay was less in

  16. An international based survey on perioperative use of tranexamic acid in neurotrauma

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    Moscote-Salazar Luis Rafael

    2016-06-01

    Full Text Available Background: Tranexamic acid is used to reduce bleeding, easy to use, affordable and relatively safe. There are few studies on the use of tranexamic acid in trauma and especially in neurosurgery. There is no published study on the trend the use of tranexamic acid in neurotrauma surgery among international doctors. The aim of this study was to evaluate the current practice for use of tranexamic acid during neurotrauma surgery.

  17. The progress of application of tranexamic acid in off-pump coronary artery bypass surgery%氨甲环酸在非体外循环冠状动脉搭桥术的应用进展

    Institute of Scientific and Technical Information of China (English)

    孙加晓; 王常松; 李恩有

    2013-01-01

    Background With rapid development of medical science,tranexamic acid (TA) has received more and more attention as a antifibrinolytic drug in off-pump coronary artery bypass (OPCAB) surgery in recent years.Objective To investigate the application of TA in OPCAB surgery and to provide scientific reference for clinical practice.Content To summerize the mechanism and its clinical application of TA in OPCAB surgery.Trend To promote a safer and more effective application of TA in OPCAB surgery.%背景 近年来,伴随着医学的快速发展,非体外循环冠状动脉搭桥术(off-pump coronary artery bypass,OPCAB)的应用逐渐增多,氨甲环酸(tranexamic acid,TA)作为抗纤溶药物在OPCAB中的作用倍受关注. 目的 探讨TA在OPCAB中的应用,为临床实践提供科学参考. 内容 综述TA的作用机制及其在OPCAB中的应用进展. 趋向 使TA更加安全、有效地应用于OPCAB中.

  18. Assessment of the effect of tranexamic acid on perioperative bleeding in pediatric patients undergoing tonsillectomy

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    Rabie Soliman

    2015-10-01

    Conclusion: The present study showed no effect of tranexamic acid in decreasing the tonsillectomy-related bleeding and there is no complication related to tranexamic acid. We are recommending other studies to measure the fibrinolytic activity during tonsillectomy and its inhibition by tranexamic acid.

  19. Spectrophotometric determination of tranexamic acid using vanillin

    Institute of Scientific and Technical Information of China (English)

    EM.A.Rind; M.G.H.Laghari; A.H.Memon; U.R.Mughal; F. Almani; N.Me-mon; M.Y.Khuhawar; M.L.Maheshwari

    2009-01-01

    A new spectrophotometric method has been examined for the determination of the tranexamic acid (TA)by derivatization with vanillin(VAN).The molar absorptivity of TA was calculated 25 160 L·mol-1·cm-1at λ max 354 nm and obeyed the Beer's law within 0.5-2.5 μg·mL-1.The color reaction was highly stable and didnot show any change in absorbance up to 24 h.The method was applied for the analysis of TA from capsules,injections and tooth pastes.The amounts of TA found in capsules,injections and tooth pastes of various pharmaceutical companies were observed with 249.0-250.9 mg/capsule,249.3-250.7 mg/injection and 0.048%-0.049%in tooth pastes with relative standard deviation(RSD)0.2%-5.0%(n=3).

  20. The amelioration effect of tranexamic acid in wrinkles induced by skin dryness.

    Science.gov (United States)

    Hiramoto, Keiichi; Sugiyama, Daijiro; Takahashi, Yumi; Mafune, Eiichi

    2016-05-01

    Tranexamic acid (trans-4-aminomethylcyclohexanecarboxylic acid) is a medical amino acid widely used as an anti-inflammatory and a whitening agent. This study examined the effect of tranexamic acid administration in wrinkle formation following skin dryness. We administered tranexamic acid (750mg/kg/day) orally for 20 consecutive days to Naruto Research Institute Otsuka Atrichia (NOA) mice, which naturally develop skin dryness. In these NOA mice, deterioration of transepidermal water loss (TEWL), generation of wrinkles, decrease of collagen type I, and increases in mast cell proliferation and tryptase and matrix metalloproteinase (MMP-1) release were observed. However, these symptoms were improved by tranexamic acid treatment. Moreover, the increase in the β-endorphin level in the blood and the expression of μ-opioid receptor on the surface of fibroblasts increased by tranexamic acid treatment. In addition, when the fibroblasts induced by tranexamic acid treatment were removed, the amelioration effect by tranexamic acid treatment was halved. On the other hand, tranexamic acid treated NOA mice and mast cell removal in tranexamic acid treated NOA mice did not result in changes in the wrinkle amelioration effect. Additionally, the amelioration effect of mast cell deficient NOA mice was half that of tranexamic acid treated NOA mice. These results indicate that tranexamic acid decreased the proliferation of mast cells and increases the proliferation of fibroblasts, subsequently improving wrinkles caused by skin dryness. PMID:27133035

  1. Secapin, a bee venom peptide, exhibits anti-fibrinolytic, anti-elastolytic, and anti-microbial activities.

    Science.gov (United States)

    Lee, Kwang Sik; Kim, Bo Yeon; Yoon, Hyung Joo; Choi, Yong Soo; Jin, Byung Rae

    2016-10-01

    Bee venom contains a variety of peptide constituents that have various biological, toxicological, and pharmacological actions. However, the biological actions of secapin, a venom peptide in bee venom, remain largely unknown. Here, we provide the evidence that Asiatic honeybee (Apis cerana) secapin (AcSecapin-1) exhibits anti-fibrinolytic, anti-elastolytic, and anti-microbial activities. The recombinant mature AcSecapin-1 peptide was expressed in baculovirus-infected insect cells. AcSecapin-1 functions as a serine protease inhibitor-like peptide that has inhibitory effects against plasmin, elastases, microbial serine proteases, trypsin, and chymotrypsin. Consistent with these functions, AcSecapin-1 inhibited the plasmin-mediated degradation of fibrin to fibrin degradation products, thus indicating the role of AcSecapin-1 as an anti-fibrinolytic agent. AcSecapin-1 also inhibited both human neutrophil and porcine pancreatic elastases. Furthermore, AcSecapin-1 bound to bacterial and fungal surfaces and exhibited anti-microbial activity against fungi and gram-positive and gram-negative bacteria. Taken together, our data demonstrated that the bee venom peptide secapin has multifunctional roles as an anti-fibrinolytic agent during fibrinolysis and an anti-microbial agent in the innate immune response. PMID:27208884

  2. Maternal malaria induces a procoagulant and antifibrinolytic state that is embryotoxic but responsive to anticoagulant therapy.

    Directory of Open Access Journals (Sweden)

    John W Avery

    Full Text Available Low birth weight and fetal loss are commonly attributed to malaria in endemic areas, but the cellular and molecular mechanisms that underlie these poor birth outcomes are incompletely understood. Increasing evidence suggests that dysregulated hemostasis is important in malaria pathogenesis, but its role in placental malaria (PM, characterized by intervillous sequestration of Plasmodium falciparum, proinflammatory responses, and excessive fibrin deposition is not known. To address this question, markers of coagulation and fibrinolysis were assessed in placentae from malaria-exposed primigravid women. PM was associated with significantly elevated placental monocyte and proinflammatory marker levels, enhanced perivillous fibrin deposition, and increased markers of activated coagulation and suppressed fibrinolysis in placental plasma. Submicroscopic PM was not proinflammatory but tended to be procoagulant and antifibrinolytic. Birth weight trended downward in association with placental parasitemia and high fibrin score. To directly assess the importance of coagulation in malaria-induced compromise of pregnancy, Plasmodium chabaudi AS-infected pregnant C57BL/6 mice were treated with the anticoagulant, low molecular weight heparin. Treatment rescued pregnancy at midgestation, with substantially decreased rates of active abortion and reduced placental and embryonic hemorrhage and necrosis relative to untreated animals. Together, the results suggest that dysregulated hemostasis may represent a novel therapeutic target in malaria-compromised pregnancies.

  3. Risk factors associated with postoperative seizures in patients undergoing cardiac surgery who received tranexamic acid: A case-control study

    Directory of Open Access Journals (Sweden)

    Felix R Montes

    2012-01-01

    Full Text Available Antifibrinolytic agents are used during cardiac surgery to minimize bleeding and reduce exposure to blood products. Several reports suggest that tranexamic acid (TA can induce seizure activity in the postoperative period. To examine factors associated with postoperative seizures in patients undergoing cardiac surgery who received TA. University-affiliated hospital. Case-control study. Patients undergoing cardiac surgery with cardiopulmonary bypass (CPB between January 2008 and December 2009 were identified. During this time, all patients undergoing heart surgery with CPB received TA. Cases were defined as patients who developed seizures that required initiation of anticonvulsive therapy within 48 h of surgery. Exclusion criteria included subjects with preexisting epilepsy and patients in whom the convulsive episode was secondary to a new ischemic lesion on brain imaging. Controls who did not develop seizures were randomly selected from the initial cohort. From an initial cohort of 903 patients, we identified 32 patients with postoperative seizures. Four patients were excluded. Twenty-eight cases and 112 controls were analyzed. Cases were more likely to have a history of renal impairment and higher preoperative creatinine values compared with controls (1.39 ± 1.1 vs. 0.98 ± 0.02 mg/dL, P = 0.02. Significant differences in the intensive care unit, postoperative and total lengths of stay were observed. An association between high preoperative creatinine value and postoperative seizure was identified. TA may be associated with the development of postoperative seizures in patients with renal dysfunction. Doses of TA should be reduced or even avoided in this population.

  4. Blood loss and limb circumference changes in patients undergoing unilateral total knee arthroplasty after intra-articular injection of tranexamic acid:a randomized controlled trial%关节腔注射氨甲环酸单侧全膝关节置换者的失血量及肢体周径变化:随机对照

    Institute of Scientific and Technical Information of China (English)

    马金辉; 孙伟; 高福强; 王云亭; 李子荣

    2014-01-01

    BACKGROUND:Tranexamic acid has been more and more used in reducing bleeding after joint replacement, but its usage method and dosage remain controversial, and become a hot focus in recent years. OBJECTIVE:To investigate the efficacy of intra-articular injection of tranexamic acid on postoperative blood loss and limb circumference changes in patients who received unilateral total knee arthroplasty. METHODS:From March to October 2013, clinical data of 90 patients undergoing primary unilateral total knee arthroplasty were randomized to the tranexamic acid group and the control group, including 19 males and 71 females. The 30 patients in the tranexamic acid group received 50 mL of 3%tranexamic acid dilute solution inside knee joint after capsule closure, and 60 patients in the control group received the same volume of physiological saline. No significant difference in age, height, body mass index, anticoagulation, the type of prosthesis, tourniquet time and preoperative diagnosis was detected between the two groups (P>0.05). The amounts of intraoperative and postoperative blood loss and blood transfusion, postoperative drainage volume, the preoperative and postoperative limb circumference 10 cm above the operated knee were recorded. Routine blood test was reviewed after the surgery. RESULTS AND CONCLUSION:There were no significant differences in total blood loss, postoperative drainage volume and limb circumference changes between tranexamic acid and control groups (P>0.05). The amount of postoperative hidden blood loss was significantly less in the tranexamic acid group than in the control group (t=-2.683, P0.05)。记录患者术中及术后失血量和输血量、术后第1天引流量,测量术前及术后术侧膝上10 cm肢体周径,术后连续复查血常规。结果与结论:氨甲环酸组和对照组手术总失血量、术后第1天引流量与术侧肢体周径变化情况比较差异均无显著性意义(P>0.05),术后隐性失

  5. 促凝血剂—Tranexamic acid

    Institute of Scientific and Technical Information of China (English)

    梁茵

    1999-01-01

    Tranexamic acid是一种赖氨酸的合成衍生物,通过对结合于纤维蛋白溶酶原分子上赖氨酸的可逆性阻断,从而产生抗溶解纤维蛋白原的作用。静注tranexamic acid(多数注射1mg/kg/hr后再静注10mg/kg)令使用心肺分流术(CPB)进行心脏手术的患者术后失血相对安慰剂受试者减少29-54%,在一些试验中,使用tranexamic acid后要求输血的病例也显著减少,在减少术后要求输血的病例也显著减少,在减少术后失血方面,tranexamic acid与2×106血管舒缓素抑制单位(KIU)的抑肽酶作用类似,但优于双嘧啶氨醇(dipyridamile)。一项试验中,用tranexamic acid要求输血者减少了43%,用抑肽酶则减少了60%。60个试验的总体分析表明,与∑-亮氨酸(EACA)和去氨加压素不同,tranexamic acid和抑肽酶显著减少使用CPB进行心脏手术后要求输注同种基因血液的病例数。用tranexamic acid的患者因上消化道出血的列席迟缓相对用安慰剂减少5-54%,总体分析表明有40%的减少。用tranexamic acid治疗妇女月经过多,相对用安慰剂,其平均月经失血减少34-57.9%。本品在胎盘出血、产后出血和子宫颈锥形切除术的使用上有良好作用。Tranexamic acid明显减少易出血患者口腔手术后的平均失血,它作为一种漱口药对服用了抗凝敌国剂的牙疾患者也是有效的,使用本品后,接受常位肝移植手术或经尿道的前列腺手术患者失血减少,外伤大量出血患者再出血率也减少,已报道遗传的血管神经性水肿患者用tranexamic acid有临床疗效。Tranexamic acid有良好耐受笥:恶心和腹泻是最常见的不良反应,本品对增加血栓形成危险还未在临床试验中获得证明。结论:Tranexamic acid有效用于出血的广泛情况。本品减少术后出血和多种手术要求的输血潜在的花费和耐受性益处优于抑肽酶,可减少上消

  6. Telangiectasia hemorrágica hereditária: ácido tranexâmico no tratamento de úlcera plantar Hereditary hemorrhagic telangiectasia: tranexamic acid for plantar ulcer

    Directory of Open Access Journals (Sweden)

    Gabriella Corrêa de Albuquerque

    2005-12-01

    Full Text Available Relato de um caso de úlcera plantar por fístula arteriovenosa em paciente portador de telangiectasia hemorrágica hereditária ou doença de Rendu-Osler-Weber tratado com ácido tranexâmico. Este fármaco é utilizado para tratamento de epistaxe, referindo-se o principal achado deste artigo ao uso eficaz desse medicamento na terapia de úlceras plantares hemorrágicas. São descritos os aspectos fisiopatológicos e clínicos da doença e as propriedades antifibrinolíticas do ácido tranexâmico. Este foi bem tolerado e apresentou evidências de eficácia na utilização para controle do sangramento e cicatrização da úlcera.Case report of one patient with Hereditary Hemorrhagic Telangiectasia, also known as Rendu-Osler-Weber syndrome, treated with Tranexamic Acid for arteriovenous plantar ulcer. This drug has proved effective in controlling epistaxis, but the main point of this report is to expose the success use of this medication in the therapy of skin bleeding ulcer. The pathophysiologic and clinical features of the disease are reviewed and also the pharmacological aspects of the antifibrinolytic drugs. This drug was well tolerated by the patient and show evidence of good activity in the bleeding and healed the ulcer.

  7. Effects of tranexamic acid during endoscopic sinsus surgery in children

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    Ahmed A Eldaba

    2013-01-01

    Full Text Available Objectives: This study was conducted to evaluate the effect of tranexamic acid (TA on the intra-operative bleeding during the functional endoscopic sinus surgery (FESS in children. Methods: A total of 100 children recruited to undergo FESS were randomized into two groups. Group I: Was given just after induction, intra-venous 25 mg/kg TA diluted in 10 ml of normal saline. Group II: Was given 10 ml of normal saline. Non-invasive blood pressure, heart rate, and quality of the surgical field were estimated every 15 min. Volume of bleeding and duration of the surgical procedure were recorded. Results: Surgical field quality after 15 min revealed that seven patients in group I had minimal bleeding versus no one in group II, P=0.006. Meanwhile, 35 patients in group I had mild bleeding versus 26 patients in group II, P=0.064. Higher number of patients in group II than in group I had moderate bleeding, P=0006. Also, at 30 min, revealed that 10 patients in group I had minimal bleeding versus one patient in group II, P=0.004. Meanwhile, 37 patients in group I had mild bleeding versus 28 patients in group II, P=0.059. Higher number of patients in group II than in group I had moderate bleeding, P<0001. Duration of the surgeries and volume of bleeding were significantly less in tranexamic group than the placebo group, P<0.0001. Conclusion: Single intra-venous bolus dose of tranexamic in children during the FESS improves quality of surgical field, reduces intra-operative bleeding, and duration of surgery.

  8. DOES TRANEXAMIC ACID REDUCE BLOOD LOSS IN OFF-PUMP CORONARY ARTERY BYPASS?

    OpenAIRE

    A. Mehr-Aein; M. Sadeghi M. Madani-Civi

    2006-01-01

    Tranexamic acid is now used on a routine basis for on-pump coronary artery bypass grafting (CABG). We assessed the hemostatic effects of tranexamic acid to decrease bleeding tendency and transfusion requirements in patients undergoing off-pump coronary artery bypass surgery (OPCAB). A total of 66 patients were enrolled to elective OPCAB in a double-blind, prospective randomized study. Of these, 33 patients received tranexamic acid (15 mg/kg before the infusion of heparin and 15 mg/kg after pr...

  9. Tranexamic Acid and Oxytocin in the Reduction of Perioperative Blood Loss for Myomectomy: Randomized Controlled Trial%氨甲环酸联合缩宫素减少子宫肌瘤剔除术围手术期出血的随机对照研究

    Institute of Scientific and Technical Information of China (English)

    王琦; 赵菊美; 程静

    2012-01-01

    目的 探讨联合应用氨甲环酸和缩宫素对降低子宫肌瘤剔除术围手术期出血量的有效性和安全性.方法 选择2008年1月至2010年12月于本院拟行经腹子宫肌瘤剔除术后的患者150例为研究对象.将其按照人院顺序随机纳入A组(n=50,静脉滴注氨甲环酸+缩宫素止血治疗),B组(n=50,静脉滴注缩宫素止血治疗)和C组(n=50,静脉滴注氨甲环酸止血治疗).围手术期止血措施采取双盲法进行,除研究设计者外,受试对象本人与研究实施者对具体措施均不知晓(本研究遵循的程序符合本院人体试验委员会所制定的伦理学标准,得到该委员会批准,分组征得受试对象本人的知情同意,并与之签署临床研究知情同意书).对3种子宫肌瘤剔除术围手术期止血效果[术中及术后出血量、术后输血率、术后血红蛋白(Hb)水平]进行统计学分析.结果 本研究4例受试对象因术中发现子宫肌瘤剔除术困难而改行子宫次全切除术.因此,A,B及C组实际纳入患者分别为49例,48例及49例.3组患者一般临床资料比较,差异无统计学意义(P>0.05).所有患者对上述围手术期的止血措施均无明显不良反应.A组术中出血量[(257±180)mL]明显低于B组[(490±368) mL]和C组[(538±352) mL],组间比较,差异有统计学意义(P<0.001);而B组和C组术中出血量比较,差异无统计学意义(P=0.513).3组间术后出血量、术后Hb水平和输血率比较,差异无统计学意义(P>0.05).结论 氨甲环酸联合缩宫素可有效降低子宫肌瘤剔除术的术中出血量,并且明显优于二者单独应用.单独使用氨甲环酸或缩宫素对子宫肌瘤剔除术围手术期的止血效果相当.%Objective To investigate the effect and safety of tranexamic acid and oxytocin in perioperative blood loss for women underwent myomectomy.Methods From January 2008 to December 2010,a total of 150 patients who underwent open surgery of myomectomy were

  10. DOES TRANEXAMIC ACID REDUCE BLOOD LOSS IN OFF-PUMP CORONARY ARTERY BYPASS?

    Directory of Open Access Journals (Sweden)

    A. Mehr-Aein

    2006-09-01

    Full Text Available Tranexamic acid is now used on a routine basis for on-pump coronary artery bypass grafting (CABG. We assessed the hemostatic effects of tranexamic acid to decrease bleeding tendency and transfusion requirements in patients undergoing off-pump coronary artery bypass surgery (OPCAB. A total of 66 patients were enrolled to elective OPCAB in a double-blind, prospective randomized study. Of these, 33 patients received tranexamic acid (15 mg/kg before the infusion of heparin and 15 mg/kg after protamin infusion, and 33 patients received only saline. Preoperative hematologic variables, postoperative bleeding and allogeneic transfusions were considered. D-dimer plasma levels were also evaluated to monitor the activation of fibrinolysis. Postoperative bleeding was significantly lower in the tranexamic acid group compared with the control group (320 ± 38 mL vs. 480 ± 75 mL at 12 hour, P < 0.001. The tranexamic acid group had significantly lesser need for allogeneic blood products (0.46 units/patients vs. 0.94 units/patients, P < 0.001. They had also lower post-operative D-dimer plasma levels. No postoperative thrombotic complications were observed in either group. The defective hemostasis occurs even in the OPCABG. Tranexamic acid effectively reduces postoperative blood loss and the need for allogeneic blood products after OPCAB is decreased.

  11. Suspected Transfusion Related Acute Lung Injury Improving following Administration of Tranexamic Acid: A Case Report

    Directory of Open Access Journals (Sweden)

    Stan Ryniak

    2014-01-01

    Full Text Available A 16-year-old woman with craniofacial injury developed severe acute respiratory failure under the primary reconstructive surgical procedure requiring several units of blood and plasma. A transfusion related acute lung injury (TRALI was suspected and supportive treatment was initiated. Because of the severity of symptoms, acute extracorporeal membrane oxygenation (ECMO was planned. During preparation for ECMO, a single intravenous dose, 1 g of tranexamic acid, was administered and a remarkable improvement was observed shortly thereafter. The patient was placed on ECMO for 16 hours. The further course was uncomplicated and the patient was discharged from ICU on the 6th day after admission fully and she recovered. A clinical improvement was observed in a timely fashion following the administration of tranexamic acid. The handling of a suspected TRALI and potential benefit from administration of tranexamic acid are discussed in this case report.

  12. Efficacy of tranexamic acid in reducing blood loss during lower segment caesarean section

    Directory of Open Access Journals (Sweden)

    Vijayalaxmi Raghavendra Gobbur

    2014-04-01

    Results: Tranexamic acid significantly reduced the quantity of blood loss during LSCS 289.4 +/- 71.4 ml in the study group versus 328 +/- 58.9 ml in the control group (P = 0.004. It also significantly reduced the quantity of blood loss from placental delivery to 2 hours post-partum: 360.9 +/- 110.3 ml in the study group, versus 443 +/- 88.55 ml in the control group. (P = 0.0008. No complications or side effects were reported in either group. Conclusions: Tranexamic acid significantly reduces the blood loss during and after the caesarean section. Side effects like nausea, vomiting, diarrhoea and thrombosis are rare. Tranexamic acid can be used effectively in women undergoing LSCS to decrease the blood loss. [Int J Reprod Contracept Obstet Gynecol 2014; 3(2.000: 414-417

  13. 氨甲环酸用于全膝关节置换降低失血量的有效性及安全性%Tranexamic acid reduces blood loss in total knee arthroplasty:effectiveness and safety

    Institute of Scientific and Technical Information of China (English)

    曹万军; 朱绍灵; 刘显东; 唐承杰; 郑金文; 陈星宇; 刘颖; 肖鹏

    2015-01-01

    背景:氨甲环酸是一种人工合成的抗纤维蛋白溶解的药物,可以经静脉有效的控制全膝关节置换后失血。目的:观察氨甲环酸对初次行单侧全膝关节置换患者置换后失血的有效性及安全性。方法:选取2014至2015年在四川省骨科医院下肢科行单侧全膝关节置换的100例患者。以使用氨甲环酸与否分为试验组和对照组,各50例。试验组患者在全膝关节置换前10 min静脉注射氨甲环酸1 g,而对照组不给予氨甲环酸。结果与结论:试验组患者置换后围手术期总失血量、置换后24 h引流量、输血量明显少于对照组(P <0.05);试验组与对照组术中出血量、输血人数差异无显著性意义。两组患者患者置换前血红蛋白水平差异无显著性意义,而置换后血红蛋白水平均下降,且试验组患者置换后血红蛋白水平均明显高于对照组。置换后24 h,两组患者凝血功能差异无显著性意义。置换后6 d,2组患者双下肢静脉彩色多普勒超声检查均未见深静脉血栓。提示初次单侧全膝关节置换前静脉给予氨甲环酸能明显减少围手术期失血量及输血量,降低输血风险及输血费用,利于术后功能恢复,且不增加下肢深静脉血栓的风险。%BACKGROUND:Tranexamic acid is a synthetic anti-fibrinolytic drug, and can effectively control blood loss after total knee arthroplasty through vein. OBJECTIVE:To evaluate the effectiveness and safety of tranexamic acid in reducing blood loss after primary unilateral total knee arthroplasty. METHODS:From 2014 to 2015, 100 patients from the Department of Lower Limb, Sichuan Orthopaedic Hospital underwent primary unilateral total knee arthroplasty, and randomly divided into test group which used tranexamic acid and control group which used tranexamic acid, with 50 cases in each group. 1 g tranexamic acid was infused into the vein at 10 minutes before total knee arthroplasty

  14. 氨甲环酸在全膝关节置换术中有效性与安全性的研究进展(综述)%Progress of efficacy and safety study of tranexamic acid in total knee arthroplasty

    Institute of Scientific and Technical Information of China (English)

    孟涛; 尚希福

    2015-01-01

    行全膝关节置换术的患者常因出现围手术期显性和隐性大量失血而需要输血,这不仅会增加患者输血相关并发症的发生率,加重其经济负担,也会影响患肢术后病情与功能的恢复.近年来,人工合成抗纤溶药氨甲环酸被应用于临床以控制围手术期失血,但其最佳治疗方案尚未统一,临床应用后血栓形成等相关并发症的发生率是否提高尚不明确.该文通过回顾与综合近年来相关报道,就其临床应用的作用机制、使用方法、使用剂量、应用效果及安全性等方面作一综述.%The patients who were undergoing total knee arthroplasty often need a blood transfusion due to a large number of overt or hidden blood loss during the perioperative period,it not only will increase the economic burden and the incidence of complications associated with blood transfusion,but also affect the postoperative condition and the recovery of limb function.In recent years,tranexamic acid as a kind of synthetic antifibrinolytic agent has been used to control the blood loss during the perioperative period.However,the best treatment prescription has not been unified,and the incidence of thrombosis or other complications associated with tranexamic acid is not clear.In this article,we summarized the relevant reports to review the mechanism,methods,dosage,efficacy and safety of the application of tranexamic acid in total knee arthroplasty.

  15. Comparison effect of intravenous tranexamic acid and misoprostol for postpartum haemorrhage

    Directory of Open Access Journals (Sweden)

    Farnaz Sahhaf

    2014-01-01

    Full Text Available Background: Postpartum haemorrhage (PPH is the third-most common cause of maternal death in the United States and it is still the first prevalent cause of maternal death in developing countries. Active prevention of haemorrhage with an uterotonic or other new drugs leads to a decrease in postpartum vaginal haemorrhage. The aim of this study was to compare anti-haemorrhagic effect of Tranexamic acid (TXA and Misoprostol for PPH. Patients and Methods: In a double-blinded randomised control clinical trial, 200 women were included after Caesarean or natural vaginal delivery with abnormal PPH. They were divided into two equal intervention and control groups. Effect of intravenous TXA and Misoprostol for postpartum haemorrhage was examined. Results: The mean age of patients was 26.7 ± 6.5 years which ranged from 14 to 43 years. The sonographic gestational age in the group treated with TXA was 37.7 ± 3.4 weeks and it was 37.4 ± 3.3 weeks for the other group (P = 0.44. The haemorrhage in the TXA and Misoprostol groups was 1.2 ± 0.33 litres and 1.18 ± 0.47 litres, respectively (P = 0.79. The haemoglobin levels after 6-12 hours of labour, in TXA group was more than that of the Misoprostol group, but this difference was not statistically significant (P = 0.22 and P = 0.21, respectively. Conclusion: Regarding to the superior results in Misoprostol group in one hand and lack of significant differences between two groups in haemorrhage during labour, post-partum haemoglobin level and discharge haemoglobin level, we can state that Misoprostol has no specific preferences to TXA, but more studies with greater population are needed.

  16. Treatment of postoperative bleeding after fondaparinux with rFVIIa and tranexamic acid.

    NARCIS (Netherlands)

    Huvers, F.C.; Slappendel, R.; Benraad, B.; Hellemondt, G. van; Kraaij, M.G.J. van

    2005-01-01

    Treatment of a haemorrhagic shock after just a single dose of fondaparinux in an orthopaedic patient with reduced renal clearance is presented. Since all routine haemostatic parameters were nearly normal, single doses of rFVIIa (90 microg/kg) and of tranexamic acid (15 mg/kg) were administered to im

  17. Tranexamic acid reduces blood loss in patients with extracapsular fractures of the hip

    DEFF Research Database (Denmark)

    Tengberg, P T; Foss, N B; Palm, H;

    2016-01-01

    AIMS: We chose unstable extra-capsular hip fractures as our study group because these types of fractures suffer the largest blood loss. We hypothesised that tranexamic acid (TXA) would reduce total blood loss (TBL) in extra-capsular fractures of the hip. PATIENTS AND METHODS: A single-centre plac...

  18. Use of tranexamic acid in primary total knee replacement: effects on perioperative blood loss

    Directory of Open Access Journals (Sweden)

    Daniel Volquind

    2016-06-01

    Full Text Available ABSTRACT BACKGROUND AND OBJECTIVES: The use of tranexamic acid in primary total knee replacement surgeries has been the subject of constant study. The strategies to reduce bleeding are aimed at reducing the need for blood transfusion due to the risks involved. In this study we evaluated the use of tranexamic acid in reducing bleeding, need for blood transfusion, and prevalence of postoperative deep vein thrombosis in primary total knee replacement. METHOD: 62 patients undergoing primary total knee replacement were enrolled in the study, from June 2012 to May 2013, and randomized to receive a single dose of 2.5 g of intravenous tranexamic acid (Group TA or saline (Group GP, 5 min before opening the pneumatic tourniquet, respectively. Hemoglobin, hematocrit, and blood loss were recorded 24 h after surgery. Deep vein thrombosis was investigated during patient's hospitalization and 15 and 30 days after surgery in review visits. RESULTS: There was no demographic difference between groups. Group TA had 13.89% decreased hematocrit (p = 0.925 compared to placebo. Group TA had a decrease of 12.28% (p = 0.898 in hemoglobin compared to Group GP. Group TA had a mean decrease of 187.35 mL in blood loss (25.32% compared to group GP (p = 0.027. The number of blood transfusions was higher in Group GP (p = 0.078. Thromboembolic events were not seen in this study. CONCLUSION: Tranexamic acid reduced postoperative bleeding without promoting thromboembolic events.

  19. Derivatization/chromophore introduction of tranexamic acid and its HPLC determination in pharmaceutical formulations

    Directory of Open Access Journals (Sweden)

    M. Ashfaq

    2015-04-01

    Full Text Available A viable cost-effective and isocratic approach employing C-18 column (250 mm × 4.6 mm, 5 μm based HPLC has been utilized to separate and estimate the drug, tranexamic acid in pharmaceutical formulations. Tranexamic acid contains no π-electrons to act as fluorophore or chromophore hence pre-column derivatization was performed with benzene sulfonyl chloride in aqueous medium at room temperature. The derivatized drug was then estimated using C-18 column by exploiting a 25:75 (v/v solvent mixture of acetonitrile and 0.1 M ammonium acetate (pH 5.0 as the mobile phase. The flow rate of mobile phase was 1 mL/min and detection was performed at a wavelength of 232 nm using UV detector. Retention time of tranexamic acid was 4.42 min. The method followed linear regression equation in the concentration range of 1–100 μg/mL with co-efficient of determination equal to 0.9994. The limit of detection and limit of quantitation were 0.3 and 1 μg/mL, respectively. The relative standard deviation and recovery ranges for tranexamic acid were found to be 0.11–2.47% and 97.60–103.25%, respectively. The suggested method is very sensitive and may have the potential to be used for tranexamic acid detection in medicinal formulations.

  20. Meta-analysis for the efficacy and safety of tranexamic acid in total knee arthroplasty%全膝关节置换中应用氨甲环酸有效性及安全性的Meta分析

    Institute of Scientific and Technical Information of China (English)

    李飞雄; 王智勇; 张志强

    2015-01-01

      结果与结论:共纳入随机对照试验17篇。Meta分析结果显示,与对照组相比,氨甲环酸能够降低全膝关节置换患者总失血量[MD=-314.96,95%CI(-448.76,-181.16)]、术后失血量[MD=-417.72,95%CI (-508.87,-326.56)],降低输血率[RR=0.43,95%CI(0.37,0.51)],而两组深静脉血栓[RR=0.98,95%CI(0.38,2.52)]、肺栓塞症发生率差异无显著性意义。提示氨甲环酸能够降低全膝关节置换失血量及输血率,不增加深静脉血栓肺栓塞症和感染的发生风险。%BACKGROUND:Increasing evidence has found that, tranexamic acid could reduce blood loss during total knee arthroplasty, but the efficacy and safety remain controversial. Whether tranexamic acid can reduce blood loss and increase the risk of thrombosis during the perioperative period, needs further systemic evaluation. OBJECTIVE:To explore the safety and effectiveness of tranexamic acid in the total knee arthroplasty through a meta-analysis. METHODS:Randomized control ed trials on tranexamic acid in total knee arthroplasty were retrieved from relevant databases. Al retrieved documents and references were used as supplementary information. According to the inclusion and exclusion criteria, retrieved documents were screened and the quality was assessed, then meta-analyses were performed by using the RevMan 5.1 software. The mean difference of blood loss, the risk ratio of transfusion, and the incidence of deep vein thrombosis and pulmonary embolism in the tranexamic acid and control groups were calculated. RESULTS AND CONCLUSION:Total y 17 randomized control ed studies were included. Meta-analysis results showed that, tranexamic acid significantly reduced the total blood loss [MD=-314.96, 95%CI(-448.76,-181.16)], postoperative blood loss [MD=-417.72, 95%CI(-508.87,-326.56)], and the proportion of patients requiring blood transfusion [RR=0.43, 95%CI(0.37, 0.51)], when compared with the control group. The incidence of deep vein

  1. Efficiency and Safety of Intravenous Tranexamic Acid in Simultaneous Bilateral Total Knee Arthroplasty: A Systematic Review and Meta-analysis.

    Science.gov (United States)

    Jiang, Xuan; Ma, Xin-Long; Ma, Jian-Xiong

    2016-08-01

    The objective of this systematic review and meta-analysis was to evaluate the efficacy and safety of i.v. tranexamic acid (TXA) in simultaneous bilateral total knee arthroplasty (TKA). Potentially relevant published reports were identified from the following electronic databases: Medline, PubMed, Embase, ScienceDirect and Cochrane Library. RevMan v5.3was used to pool data. Two randomized controlled trials and four case-control studies met the inclusion criteria. The current meta-analysis identified significant differences between TXA group and control groups in terms of postoperative hemoglobin concentration (P < 0.01), drainage volume (P < 0.01), transfusion rate (P < 0.01) and units transfused (P = 0.006). There were no significant differences in length of stay (P = 0.66), operation time (P = 0.81) or and incidence of adverse effects such as infection (P = 0.42), deep venous thrombosis (DVT) (P = 0.88) and pulmonary embolism (PE) (P = 0.11). Our results show that i.v. administration of TXA in simultaneous bilateral TKA reduces postoperative drops in hemoglobin concentration, drainage volume, and transfusion requirements and does not prolong length of stay or operation time. Moreover, no adverse effects, such as infection, DVT or PE, were associated with TXA. PMID:27627710

  2. Efficiency and Safety of Intravenous Tranexamic Acid in Simultaneous Bilateral Total Knee Arthroplasty: A Systematic Review and Meta-analysis.

    Science.gov (United States)

    Jiang, Xuan; Ma, Xin-Long; Ma, Jian-Xiong

    2016-08-01

    The objective of this systematic review and meta-analysis was to evaluate the efficacy and safety of i.v. tranexamic acid (TXA) in simultaneous bilateral total knee arthroplasty (TKA). Potentially relevant published reports were identified from the following electronic databases: Medline, PubMed, Embase, ScienceDirect and Cochrane Library. RevMan v5.3was used to pool data. Two randomized controlled trials and four case-control studies met the inclusion criteria. The current meta-analysis identified significant differences between TXA group and control groups in terms of postoperative hemoglobin concentration (P < 0.01), drainage volume (P < 0.01), transfusion rate (P < 0.01) and units transfused (P = 0.006). There were no significant differences in length of stay (P = 0.66), operation time (P = 0.81) or and incidence of adverse effects such as infection (P = 0.42), deep venous thrombosis (DVT) (P = 0.88) and pulmonary embolism (PE) (P = 0.11). Our results show that i.v. administration of TXA in simultaneous bilateral TKA reduces postoperative drops in hemoglobin concentration, drainage volume, and transfusion requirements and does not prolong length of stay or operation time. Moreover, no adverse effects, such as infection, DVT or PE, were associated with TXA.

  3. The Value of Tranexamic Acid in Reducing Blood Loss following Hip Reconstruction in Children with Cerebral Palsy

    Science.gov (United States)

    Majid, I.; Alshryda, S.; Somanchi, B.; Morakis, E.; Foster, A.

    2015-01-01

    This is a retrospective study of 51 consecutive hip reconstructions in children with cerebral palsy performed between 2011 and 2013. Tranexamic acid (TXA) was used in 14 hip reconstructions only. Transfusion rate was higher, postoperative Hb was lower, and patients stayed longer in the TXA group. This did not reach a statistical significance (P = 0.75, 0.5, and 0.71, resp.). More than half of the patients who had TXA underwent bilateral hip reconstructions in comparison with 27% only in the non-TXA group. Bilateral hip reconstructions mean more surgery, more blood loss, and more blood transfusion. The patients who had TXA were significantly more disabled as evident by the higher proportions of patient with worse GMFCS levels. Although we have not been able to demonstrate the value of TXA in reducing blood loss and transfusion rate in children with CP who underwent hip reconstruction, it is hoped that an interest in exploring the value of TXA in paediatric orthopaedic surgery is generated. Ideally this should be explored further in an adequately powered, randomised controlled trial where risk of bias is minimized. PMID:26664830

  4. The Value of Tranexamic Acid in Reducing Blood Loss following Hip Reconstruction in Children with Cerebral Palsy

    Directory of Open Access Journals (Sweden)

    I. Majid

    2015-01-01

    Full Text Available This is a retrospective study of 51 consecutive hip reconstructions in children with cerebral palsy performed between 2011 and 2013. Tranexamic acid (TXA was used in 14 hip reconstructions only. Transfusion rate was higher, postoperative Hb was lower, and patients stayed longer in the TXA group. This did not reach a statistical significance (P = 0.75, 0.5, and 0.71, resp.. More than half of the patients who had TXA underwent bilateral hip reconstructions in comparison with 27% only in the non-TXA group. Bilateral hip reconstructions mean more surgery, more blood loss, and more blood transfusion. The patients who had TXA were significantly more disabled as evident by the higher proportions of patient with worse GMFCS levels. Although we have not been able to demonstrate the value of TXA in reducing blood loss and transfusion rate in children with CP who underwent hip reconstruction, it is hoped that an interest in exploring the value of TXA in paediatric orthopaedic surgery is generated. Ideally this should be explored further in an adequately powered, randomised controlled trial where risk of bias is minimized.

  5. EFFICACY OF TRANEXAMIC ACID IN DECREASING BLOOD LOSS DURING AND AFTER CAESAREAN SECTION: A RANDOMIZED CASE CONTROL PROSPECTIVE STUDY

    Directory of Open Access Journals (Sweden)

    Tullika

    2014-03-01

    Full Text Available : INTRODUCTION: To reduce maternal mortality and morbidity caused by bleeding, it is important to reduce the amount of bleeding during and after lower segment caesarean section (LSCS. Tranexamic acid helps to reduce bleeding during and after LSCS. OBJECTIVES: To study the efficacy and safety of Tranexamic acid in reducing blood loss during and after Lower segment Caesarean Section (LSCS. METHODS: A randomized case controlled prospective study was conducted on 200 women undergoing lower segment cesarean section. Hundreds of them that were given tranexamic acid immediately before LSCS were compared to hundred others to whom tranexamic acid was not given. Blood loss was collected and measured during the two periods, from plancental delivery to end of LSCS and second from end of LSCS to two hours postpartum. RESULTS: Tranexamic acid significantly reduced the quantity of blood loss from placental delivery to end of LSCS, 202.25ml in the study group vs392.20 ml in the control group (p<0.001; from the end of LSCS, to 2 hours postpartum 3.80ml in the study group versus 112.25ml in the control group (p<0.001; In totality, it significantly reduced the quantity of blood loss from placental delivery to two hours postpartum i.e. 27.05ml in the study group versus 510.45ml in the control group (p < 0.001. No complications or side effects were noted. CONCLUSION: Tranexamic acid significantly reduced the amount of blood loss during and after LSCS. Tranexamic acid can be used prophylactically; moreover it is safer and effective in women undergoing LSCS.

  6. 全膝关节置换中静脉与关节腔内应用氨甲环酸效果比较的Meta分析%Clinical outcomes of intra-articular route versus intravenous route of tranexamic acid during total knee arthroplasty:a meta-analysis

    Institute of Scientific and Technical Information of China (English)

    周恺棣; 王弘毅; 燕宇飞; 洪伟祥; 冯建民

    2016-01-01

    背景:研究证实在全膝关节置换中,静脉与关节腔内应用氨甲环酸可显著减少围手术期失血量和输血率,但目前在临床工作中对氨甲环酸的应用方式仍有争议。  目的:比较全膝关节置换中静脉与关节腔内应用氨甲环酸的临床效果。  方法:检索PubMed、OVID、Web of Science和EMBASE数据库2015年5月1日以前发表的,关于“全膝关节置换中氨甲环酸静脉与关节腔内应用对比”的随机对照临床试验,将输血率、血红蛋白下降值、引流量和血栓并发症发生率等作为评价临床效果的指标,进行Meta分析。  结果与结论:共纳入6项随机对照临床试验,包括847例患者。Meta分析结果显示,氨甲环酸静脉与关节腔内应用的输血率、血红蛋白下降程度、引流量、总失血量和血栓发生率比较差异均无显著性意义;亚组分析中,当引流管术后夹闭时间 OBJECTIVE:To compare the clinical outcomes of tranexamic acid in intra-articular route and intravenous route during total knee arthroplasty. METHODS:PubMed, OVID, Web of Science, and EMBASE were searched to identify randomized control ed trials concerning the comparison of tranexamic acid in intra-articular route and intravenous route during total knee arthroplasty published before 1 May 2015. Transfusion rate, hemoglobin decline, drainage volume and thromboembolic complication rate were considered as indexes to evaluate the clinical effect, for meta-analysis. RESULTS AND CONCLUSION:Six randomized control ed trials involving 847 patients were included. Meta-analysis results showed no significant difference between intra-articular and intravenous administration of tranexamic acid in terms of transfusion rate, hemoglobin decline, drainage volume, total blood loss, and thromboembolic complication rate. Subgroup analysis for dose regimen showed that when occlusion time of drainage tube was<2 hours. Intra

  7. Combination Intravenous and Intra-Articular Tranexamic acid compared with Intravenous Only Administration and No Therapy in Total Knee Arthroplasty: A Case Series Study

    Directory of Open Access Journals (Sweden)

    Chris Buntting

    2016-07-01

    This study supports the existing literature and suggests that the use of IV Tranexamic acid alone or in combination with intra-articular dose in TKA may reduce the requirement for transfusion (Level IV evidence. Furthermore, this study suggests that the use of tranexamic acid as a combination of Intravenous and intra-articular administration has no effect on range of motion, or medical complications during hospital stay. Although it was not a statistically significant finding, our study suggested a trend towards a greater reduction in haemoglobin and haematocrit fall in the combination therapy group when compared to IV Tranexamic acid alone

  8. Tranexamic Acid Decreases Incidence of Blood Transfusion in Simultaneous Bilateral Total Knee Arthroplasty.

    Science.gov (United States)

    Bagsby, Deren T; Samujh, Christopher A; Vissing, Jacqueline L; Empson, Janene A; Pomeroy, Donald L; Malkani, Arthur L

    2015-12-01

    Blood management for simultaneous bilateral total knee arthroplasty (TKA) patients is more challenging than in unilateral arthroplasty. We examined if administration of tranexamic acid (TXA) to patients undergoing simultaneous bilateral TKA would reduce blood loss and decrease allogeneic blood transfusion requirements. A retrospective review of 103 patients, 57 in the control and 46 in the TXA group, was performed. There was higher postoperative day 1 hemoglobin in patients receiving TXA (2.95±1.33 versus 4.33±1.19, Ptransfusion incidence with administration of TXA (17.4% versus 57.9%, Ptransfusion rates by almost 70% in simultaneous bilateral total knee arthroplasty.

  9. Tranexamic acid, an inhibitor of plasminogen activation, reduces urinary collagen cross-link excretion in both experimental and rheumatoid arthritis

    NARCIS (Netherlands)

    Ronday, H.K.; TeKoppele, J.M.; Greenwald, R.A.; Moak, S.A.; Roos, J.A.D.M. de; Dijkmans, B.A.C.; Breedveld, F.C.; Verheijen, J.H.

    1998-01-01

    The plasminogen activation system is one of the enzyme systems held responsible for bone and cartilage degradation in rheumatoid arthritis (RA). In this study, we evaluated the effect of tranexamic acid (TEA), an inhibitor of plasminogen activation, on urinary collagen cross-link excretion and radio

  10. Pregabalin and Tranexamic Acid Evaluation by Two Simple and Sensitive Spectrophotometric Methods

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    Nawab Sher

    2015-01-01

    Full Text Available This paper demonstrates colorimetric visible spectrophotometric quantification methods for amino acid, namely, tranexamic acid and pregabalin. Both drugs contain the amino group, and when they are reacted with 2,4-dinitrophenol and 2,4,6-trinitrophenol, they give rise to yellow colored complexes showing absorption maximum at 418 nm and 425 nm, respectively, based on the Lewis acid base reaction. Detailed optimization process and stoichiometric studies were conducted along with investigation of thermodynamic features, that is, association constant and standard free energy changes. The method was linear over the concentration range of 0.02–200 µgmL−1 with correlation coefficient of more than 0.9990 in all of the cases. Limit of detection was in range from 0.0041 to 0.0094 µgmL−1 and limit of quantification was in the range from 0.0137 to 0.0302 µgmL−1. Excellent recovery in Placebo spiked samples indicated that there is no interference from common excipients. The analytical methods under proposal were successfully applied to determine tranexamic acid and pregabalin in commercial products. t-test and F ratio were evaluated without noticeable difference between the proposed and reference methods.

  11. Tranexamic acid reduces the blood loss and blood transfusion requirements following peri-acetabular osteotomy.

    Science.gov (United States)

    Wassilew, G I; Perka, C; Janz, V; Krämer, M; Renner, L

    2015-12-01

    We have investigated the effect of using tranexamic acid (TXA) during peri-acetabular osteotomy (PAO) on peri-operative blood loss and blood transfusion requirements. In addition we analysed whether the use of TXA was associated with an increased risk of venous thromboembolism (VTE) following this procedure. A consecutive series of 96 PAOs, performed by a single surgeon, were reviewed. A total of 48 patients received TXA and 48 did not. The TXA group received a continuous infusion of TXA at a rate of 10 mg/kg/h. The primary outcome measure was the requirement for blood transfusion. Secondary outcomes included total blood loss, the decrease in the level of haemoglobin in the blood, the length of hospital stay, and the complications of this treatment. The mean rate of transfusion was significantly lower in the TXA group (62.5% vs 12.5%, p transfusion after PAO significantly, without adverse effects such as an increased rate of VTE.

  12. Efficacy and Safety of Tranexamic Acid in Bilateral Total Knee Replacement: A Meta-Analysis and Systematic Review

    OpenAIRE

    He, Peiheng; Zhang, Ziji; Li, Yumin; Wang, Hua; Xu, Dongliang

    2015-01-01

    Background Tranexamic acid (TXA) has been well documented to reduce blood loss and transfusion requirements in patients undergoing unilateral total knee arthroplasty (TKA). However, the efficacy and safety of TXA in simultaneous bilateral TKA have not been clearly defined. The aim of our study was to systematically review the existing evidence regarding the role of TXA in patients undergoing simultaneous bilateral TKA. Material/Methods A systematic search of all studies published through June...

  13. Intravenous 1 gram tranexamic acid for prevention of blood loss and blood transfusion during caesarean section: a randomized case control study

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    Babita Ramani

    2014-04-01

    Full Text Available Background: Aim of current study was to determine the effect of tranexamic acid in reducing blood loss during and after C-section. Methods: All women undergoing LSCS were divided in two groups viz study and control group. All were requested for pre-op and post-op Hb%, PCV and TRBC. Intravenous tranexamic acid one gm was given to study group (not to control group 10 min prior to skin incision and blood loss in both groups was calculated by weighing prewieghed pads soaked in blood. Results: Post-op blood loss was significantly lower in study group (P = 0.020. Hb% changes in post-op period is significant in control group (P = 0.037. Conclusions: Tranexamic acid is safe and effective in preventing post-partum hemorrhage after caesarean section. [Int J Reprod Contracept Obstet Gynecol 2014; 3(2.000: 366-369

  14. Tranexamic acid reduces blood loss and blood transfusions in primary total hip arthroplasty: a prospective randomized double-blind study in 40 patients

    DEFF Research Database (Denmark)

    Husted, Henrik; Blønd, Lars; Sonne-Holm, Stig;

    2003-01-01

    INTRODUCTION: We performed a prospective, randomized, double-blind study on 40 patients scheduled for primary total hip arthroplasty due to arthrosis or osteonecrosis to determine the effect of tranexamic acid on per- and postoperative blood losses and on the number of blood transfusions needed....... PATIENTS AND METHODS: 40 patients were randomized to tranexamic acid (10 mg/kg given as a bolus intravenous injection, followed by a continuous infusion of 1 mg/kg/hour for 10 hours) or placebo (20 mL saline given intravenously) 15 minutes before the incision. We recorded the peroperative and postoperative...... blood losses at removal of the drain 24 hours after the operation and the number of blood transfusions. RESULTS: Patients receiving tranexamic acid had a mean peroperative blood loss of 480 mL versus 622 mL in patients receiving placebo (p = 0.3), a postoperative blood loss of 334 mL versus 609 mL (p...

  15. 氨甲环酸用于全髋关节置换有效性与安全性的Meta分析%Efficacy and safety of tranexamic acid application in total hip arthroplasty:a meta-analysis

    Institute of Scientific and Technical Information of China (English)

    刘丙根; 庞清江

    2014-01-01

    BACKGROUND:Whether tranexamic acid can effectively and safely reduce blood loss and al ogeneic transfusion rate in total hip arthroplasty remains controversial at present. OBJECTIVE:To assess the efficacy and safety of tranexamic acid administration in total hip arthroplasty using meta-analysis. METHODS:Clinical randomized control ed trials concerning tranexamic acid application in total hip arthroplasty published from January 1969 to December 2013 were retrieved from the PubMed, Ovid, Elsevier, Cochrane library, China National Knowledge Infrastructure and Wanfang database. Intraoperative blood loss, postoperative blood loss, total blood loss, al ogeneic transfusion rate and incidence of venous thromboembolism were compared using meta-analysis between the tranexamic acid and control groups. Detection and literature references were used as supplementary data. RevMan 5.0 software provided by Cochrane col aboration was used for meta-analyses. Conclusion was obtained according to analysis. The analysis checked the heterogeneity of data. RESULTS AND CONCLUSION:After comprehensive and rigorous screening, 19 high-quality (Jadad score not less than 3) randomized control ed studies were included. Meta-analysis results demonstrated that compared with the control group, tranexamic acid decreased the total blood loss [weighted mean difference (WMD)=-341.04, 95%confidence interval (CI) (-508.10,-173.97), P<0.001], intraoperative blood loss [WMD=-63.26, 95%CI (-111.33,-15.18), P=0.01] and postoperative blood loss [WMD=-229.53, 95%CI (-338.11,-120.94), P<0.000 1], and diminished al ogeneic transfusion rate [relative risk=0.45, 95%CI (0.35, 0.57), P<0.000 1] in patients undergoing total hip arthroplasty. No significant difference in incidence of venous thromboembolism was detectable. These data suggested that tranexamic acid could reduce blood loss and transfusion rate in patients undergoing total hip arthroplasty without increasing the risk of incidence of venous thromboembolism

  16. EFFECT OF TRANEXAMIC ACID ON BLEEDING CONTROL IN TOTAL KNEE ARTHROPLASTY

    Science.gov (United States)

    SADIGURSKY, DAVID; ANDION, DANIEL; BOUREAU, PÉRICLES; FERREIRA, MARIA CORDULINA; CARNEIRO, ROGÉRIO JAMIL FERNANDES; COLAVOLPE, PAULO OLIVEIRA

    2016-01-01

    ABSTRACT Objectives: To analyze the effectiveness of intravenous (IV) tranexamic acid (TA) in reducing blood loss in total knee arthroplasty (TKA). Method: The population sample was composed of patients with a diagnosis of primary knee osteoarthritis. The patients undergoing TKA were divided in two groups. Group A: comprised patients who used IV TA and B group, formed by patients who did not use TA in the intra or post-operative period. For descriptive analysis, quantitative variables were represented by mean and standard deviations when their distribution was normal and interquartile ranges and medians for non-normal variables. Results: The mean age of patients was 68 years old, most of them were female and with involvement of the left knee. Postoperatively patients who had used IV TA showed less bleeding rate and less hemoglobin rate reduction. Conclusion: The use of IV TA in TKA reduces blood loss in peri- and postoperative periods. Regarding total blood loss reduction, hemoglobin rate and need for blood transfusions, IV TA should be used routinely during TKA since it has been shown to be safe with no increase in side effects as thromboembolic events. Level of Evidence III. Retrospective Comparative Study. PMID:27217813

  17. Tranexamic acid for control of blood loss in bilateral total knee replacement in a single stage

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    Mandeep S Dhillon

    2011-01-01

    Full Text Available Background: Tranexamic acid (TEA reduces blood loss and red cell transfusions in patients undergoing unilateral total knee arthroplasty (TKA. However, there is not much literature regarding the use of TEA in patients undergoing bilateral TKA in a single stage and the protocols for administration of TEA in such patients are ill-defined. Materials and Methods: We carried out a case control study evaluating the effect of TEA on postoperative hemoglobin (Hb, total drain output, and number of blood units transfused in 52 patients undergoing bilateral TKA in a single stage, and compared it with 56 matched controls who did not receive TEA. Two doses of TEA were administered in doses of 10 mg / kg each (slow intravenous (IV infusion, with the first dose given just before tourniquet release of the first knee and the second dose three hours after the first one. Results: A statistically significant reduction in the total drain output and requirement of allogenic blood transfusion in cases who received TEA, as compared to the controls was observed. The postoperative Hb and Hb at the time of discharge were found to be lower in the control group, and this result was found to be statistically significant. Conclusion: TEA administered in patients undergoing single stage bilateral TKA helped reduce total blood loss and decreased allogenic blood transfusion requirements. This might be particularly relevant, where facilities such as autologous reinfusion might not be available.

  18. Synthesis and description of intermolecular interactions in new sulfonamide derivatives of tranexamic acid

    Science.gov (United States)

    Ashfaq, Muhammad; Arshad, Muhammad Nadeem; Danish, Muhammad; Asiri, Abdullah M.; Khatoon, Sadia; Mustafa, Ghulam; Zolotarev, Pavel N.; Butt, Rabia Ayub; Şahin, Onur

    2016-01-01

    Tranexamic acid (4-aminomethyl-cyclohexanecarboxylic acid) was reacted with sulfonyl chlorides to produce structurally related four sulfonamide derivatives using simple and environmental friendly method to check out their three-dimensional behavior and van der Walls interactions. The molecules were crystallized in different possibilities, as it is/after alkylation at its O and N atoms/along with a co-molecule. All molecules were crystallized in monoclinic crystal system with space group P21/n, P21/c and P21/a. X-ray studies reveal that the molecules stabilized themselves by different kinds of hydrogen bonding interactions. The molecules are getting connected through O-H⋯O hydrogen bonds to form inversion dimers which are further connected through N-H⋯O interactions. The molecules in which N and O atoms were alkylated showed non-classical interaction and generated centro-symmetric R22(24) ring motif. The co-crystallized host and guest molecules are connected to each other via O-H⋯O interactions to generate different ring motifs. By means of the ToposPro software an analysis of the topologies of underlying nets that correspond to molecular packings and hydrogen-bonded networks in structures under consideration was carried out.

  19. Tranexamic Acid for Recurring Subdural Hematomas Following Surgical Evacuation: A Clinical Case Series.

    Science.gov (United States)

    Stary, Joel M; Hutchins, Leslie; Vega, Rafael A

    2016-09-01

    Background Chronic subdural hematomas (SDHs) are commonly encountered in neurosurgery. Optimal management of SDHs remains a significant challenge. Current treatment options generally include supportive care or surgical intervention. A significant proportion of patients have surgery; however, the reoperation rate is considered high. There are also cases in which additional surgical procedures would carry significant morbidity, and as a result, there is a need for nonsurgical medical therapies. We describe the use of tranexamic acid (TXA) as a nonsurgical option for the treatment of recurrent SDHs following surgery. Methods Patients were identified as candidates for potential TXA therapy and followed prospectively. The decision to administer TXA was made on the basis of history, presentation, and prognosis after further surgical intervention. Data collected included patient imaging, treatment administered, and both radiologic and clinical outcomes. Results Three patients underwent surgical evacuation of a chronic SDH (two via burr hole washout and one via craniotomy). All patients had recurrence identified on subsequent imaging. Two patients had poorer predicted outcomes if additional surgical intervention was necessary, and one refused additional surgical intervention. TXA was administered, in the same dosing and scheduled course, to all patients. Complete resolution was observed on imaging, and in the case of the patient who was symptomatic, clinical improvement was also noted. Conclusion TXA may be considered for the treatment of recurrent SDHs following surgical evacuation in patients for whom additional surgery would add significant morbidity. PMID:27300772

  20. The association between tranexamic acid and convulsive seizures after cardiac surgery: a multivariate analysis in 11 529 patients.

    Science.gov (United States)

    Sharma, V; Katznelson, R; Jerath, A; Garrido-Olivares, L; Carroll, J; Rao, V; Wasowicz, M; Djaiani, G

    2014-02-01

    Because of a lack of contemporary data regarding seizures after cardiac surgery, we undertook a retrospective analysis of prospectively collected data from 11 529 patients in whom cardiopulmonary bypass was used from January 2004 to December 2010. A convulsive seizure was defined as a transient episode of disturbed brain function characterised by abnormal involuntary motor movements. Multivariate regression analysis was performed to identify independent predictors of postoperative seizures. A total of 100 (0.9%) patients developed postoperative convulsive seizures. Generalised and focal seizures were identified in 68 and 32 patients, respectively. The median (IQR [range]) time after surgery when the seizure occurred was 7 (6-12 [1-216]) h and 8 (6-11 [4-18]) h, respectively. Epileptiform findings on electroencephalography were seen in 19 patients. Independent predictors of postoperative seizures included age, female sex, redo cardiac surgery, calcification of ascending aorta, congestive heart failure, deep hypothermic circulatory arrest, duration of aortic cross-clamp and tranexamic acid. When tested in a multivariate regression analysis, tranexamic acid was a strong independent predictor of seizures (OR 14.3, 95% CI 5.5-36.7; p < 0.001). Patients with convulsive seizures had 2.5 times higher in-hospital mortality rates and twice the length of hospital stay compared with patients without convulsive seizures. Mean (IQR [range]) length of stay in the intensive care unit was 115 (49-228 [32-481]) h in patients with convulsive seizures compared with 26 (22-69 [14-1080]) h in patients without seizures (p < 0.001). Convulsive seizures are a serious postoperative complication after cardiac surgery. As tranexamic acid is the only modifiable factor, its administration, particularly in doses exceeding 80 mg.kg(-1), should be weighed against the risk of postoperative seizures. PMID:24588023

  1. Metabolic profiling of plasma from cardiac surgical patients concurrently administered with tranexamic acid:DI-SPME-LC-MS analysis

    Institute of Scientific and Technical Information of China (English)

    Barbara Bojko; Marcin Wąsowicz; Janusz Pawliszyn

    2014-01-01

    A metabolic profile of plasma samples from patients undergoing heart surgery with the use of cardiopulmonary bypass (CPB) and concurrent administration of tranexamic acid was determined. Direct immersion solid phase microextraction (DI-SPME), a new sampling and sample preparation tool for metabolomics, was used in this study for the first time to investigate clinical samples. The results showed alteration of diverse compounds involved in different biochemical pathways. The most significant contribution in changes induced by surgery and applied pharmacotherapy was noticed in metabolic profile of lysophospholipids, triacylglycerols, mediators of platelet aggregation, and linoleic acid metabolites. Two cases of individual response to treatment were also reported.

  2. The effect of aprotinin, tranexamic acid, and aminocaproic acid on blood loss and use of blood products in major pediatric surgery : A meta-analysis

    NARCIS (Netherlands)

    Schouten, Esther S.; van de Pol, Alma C.; Schouten, Anton N. J.; Turner, Nigel M.; Jansen, Nicolaas J. G.; Bollen, Casper W.

    2009-01-01

    Objective: Aprotinin reduces the blood loss and transfusion of blood products in children undergoing major surgery. Aprotinin has been associated with severe side effects in adults, and tranexamic acid and aminocaproic acid have been found to be safer alternatives in adults. This systematic review a

  3. EFFICACY OF TRANEXAMIC ACID IN DECREASING BLOOD LOSS DURING AND AFTER CAESAREAN SECTION IN MULTIGRAVIDA PARTURIENTS: A CASE CONTROLLED PROSPECTIVE STUDY

    Directory of Open Access Journals (Sweden)

    Gunavathi Kandappan

    2016-06-01

    Full Text Available OBJECTIVES To study the efficacy of Tranexamic acid in reducing blood loss during and after the lower segment caesarean section in Multigravida parturients. METHODOLOGY A case controlled prospective study was conducted in 50 multigravida parturient women undergoing elective lower segment caesarean section in our hospital after getting Institutional Ethical Committee approval, over a period of two months. 25 of them were given Tranexamic acid 15 mg/kg immediately before caesarean section. Blood loss was collected and measured during two periods. The first period was from placental delivery to end of LSCS and the second from the end LSCS to 2 hours postpartum. RESULTS Tranexamic acid significantly reduces the quantity of blood loss from the end of LSCS to 2 hours post-partum in multigravida parturients. No complications or side effects are noted in both the groups. CONCLUSION Tranexamic acid significantly reduces the amount of blood loss during and after the lower segment caesarean section in multigravida parturients and its use was not associated with any side effects or complications.

  4. Effect of low dose tranexamic acid on intra-operative blood loss in neurosurgical patients

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    Ramya Vel

    2015-01-01

    Full Text Available Background: Blood loss is often a major complication in neurosurgery that requires transfusion of multiple units of blood. The purpose of this study was to assess the effect of tranexamic acid (TXA on intraoperative blood loss and the need for blood transfusion in patients undergoing craniotomy for tumor excision. Materials and Methods: A total of 100 patients aged 18-60 years, with American Society of Anesthesiologists physical Status 1 and 2 scheduled to undergo elective craniotomy for tumor excision were enrolled. Patients received 10 mg/kg bolus about 20 min before skin incision followed by 1 mg/kg/h infusion of either TXA or saline. Hemodynamic variables, intravenous fluid transfused, amount of blood loss and blood given were measured every 2 h. Laboratory parameters such as serum electrolytes and fibrinogen values were measured every 3 h. On the 5 th postoperative day hemoglobin (POD Hb5, Hb estimation was done and the estimated blood loss (EBL calculated. Patients were also monitored for any complications. Results: The Mean heart rate in TXA group was significantly lower compared with the saline group. Mean arterial pressure and fibrinogen levels were higher in TXA group. The mean total blood loss in the TXA group was less than in the saline group. Blood transfusion requirements were comparable in two groups. The EBL and POD5 Hb were comparable in two groups. Conclusion: Even though, there is a significant reduction in the total amount of blood loss in TXA group. However, there was no reduction in intraoperative transfusion requirement.

  5. Does tranexamic acid stabilised fibrin support the osteogenic differentiation of human periosteum derived cells?

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    J Demol

    2011-03-01

    Full Text Available Fibrin sealants have long been used as carrier for osteogenic cells in bone regeneration. However, it has not been demonstrated whether fibrin’s role is limited to delivering cells to the bone defect or whether fibrin enhances osteogenesis. This study investigated fibrin’s influence on the behaviour of human periosteum-derived cells (hPDCs when cultured in vitro under osteogenic conditions in two-dimensional (fibrin substrate and three-dimensional (fibrin carrier environments. Tranexamic acid (TEA was used to reduce fibrin degradation after investigating its effect on hPDCs in monolayer culture on plastic.TEA did not affect proliferation nor calcium deposition of hPDCs under these conditions. Expression profiles of specific osteogenic markers were also maintained within the presence of TEA, apart from reduced alkaline phosphatase (ALP expression (day 14. Compared to plastic, proliferation was upregulated on 2D fibrin substrates with a 220% higher DNA content by day 21. Gene expression was also altered, with significantly (p<0.05 decreased Runx2 (day 7 and ALP (day 14 expression and increased collagen I expression (day 14 and 21. In contrast to plastic, mineralisation was absent on fibrin substrates. Inside fibrin carriers, hPDCs were uniformly distributed. Moderate cell growth and reduced osteogenic marker expression was observed inside fibrin carriers. After 2 weeks, increased cell death was present in the carrier’s centre. In conclusion, fibrin negatively influences osteogenic differentiation, compared to culture plastic, but enhanced proliferation (at least in 2D cultures for hPDCs cultured in osteogenic conditions. TEA maintained the integrity of fibrin-based constructs, with minor effects on the osteogenic differentiation of hPDCs.

  6. Giving tranexamic acid to reduce surgical bleeding in sub-Saharan Africa: an economic evaluation

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    Perel Pablo

    2010-02-01

    Full Text Available Abstract Background The identification of safe and effective alternatives to blood transfusion is a public health priority. In sub-Saharan Africa, blood shortage is a cause of mortality and morbidity. Blood transfusion can also transmit viral infections. Giving tranexamic acid (TXA to bleeding surgical patients has been shown to reduce both the number of blood transfusions and the volume of blood transfused. The objective of this study is to investigate whether routinely administering TXA to bleeding elective surgical patients is cost effective by both averting deaths occurring from the shortage of blood, and by preventing infections from blood transfusions. Methods A decision tree was constructed to evaluate the cost-effectiveness of providing TXA compared with no TXA in patients with surgical bleeding in four African countries with different human immunodeficiency virus (HIV prevalence and blood donation rates (Kenya, South Africa, Tanzania and Botswana. The principal outcome measures were cost per life saved and cost per infection averted (HIV, Hepatitis B, Hepatitis C averted in 2007 International dollars ($. The probability of receiving a blood transfusion with and without TXA and the risk of blood borne viral infection were estimated. The impact of uncertainty in model parameters was explored using one-way deterministic sensitivity analyses. Probabilistic sensitivity analysis was performed using Monte Carlo simulation. Results The incremental cost per life saved is $87 for Kenya and $93 for Tanzania. In Botswana and South Africa, TXA administration is not life saving but is highly cost saving since fewer units of blood are transfused. Further, in Botswana the administration of TXA averts one case of HIV and four cases of Hepatitis B (HBV per 1,000 surgical patients. In South Africa, one case of HBV is averted per 1,000 surgical patients. Probabilistic sensitivity analyses confirmed the robustness of the model. Conclusion An economic

  7. 氨甲环酸在非体外循环冠脉移植手术中应用效果与安全性的系统评价%The efficacy and safety of tranexamic acid in patients undergoing off-pump coronary bypass grafting:a systematic review and meta-analysis

    Institute of Scientific and Technical Information of China (English)

    娄小飞; 阚全程; 杜书章; 付俊涛

    2015-01-01

    Objective The aim of this study is to evaluate the efficacy and safety of tranexamic acid for patients undergoing off-pump coronary bypass grafting .Methods The MEDLINE ,Embase were searched for randomized controlled trials(RCTs) of patients undergoing off-pump coronary bypass grafting .And the Cochrane Collaboration′s RevMan 5 .2 software was used to evalu-ate the quality of the included studies and to perform the meta-analyses .Results 10 trials involving 851 patients were included . Tranexamic acid significantly reduced the postoperative blood loss (24 h:SD= -208 .41 ,95% CI:-311 .48 - -105 .35 ,P<0 .000 1) ,overall risk of allogeneic blood component transfusion(RR=0 .47 ,95% CI:0 .33 -0 .66 ,P< 0 .000 1) ,and packed red blood cell transfusions(RR=0 .60 ,95% CI:0 .49-0 .74 ,P<0 .001) .But no association was found between tranexamic acid and ad-verse thrombotic events .Conclusion Tranexamic acid significantly reduced the postoperative blood loss and overall risk of allogene-ic in patients undergoing OPCAB .However ,due to the limited quality of the included studies ,further evidence with more high quali-ty studies is still needed .%目的:系统评价氨甲环酸(T A )在非体外循环冠状动脉移植手术中使用的有效性与安全性。方法计算机检索MEDLINE、Embase等数据库,收集TA用于非体外循环冠状动脉移植术的随机对照临床试验(RCT),使用Cochrane协作网的RevMan 5.2软件对纳入文献进行系统评价。结果共纳入10个RCT ,共851例患者。TA可显著减少术后总出血量(24 h:SD=-208.41,95% CI:-311.48~-105.35,P<0.0001),降低围术期同种异体输血风险(RR=0.47,95% CI:0.33~0.66,P<0.0001),可显著降低输入袋装红细胞的人数(RR=0.60,95% CI:0.49~0.74,P<0.001)。该研究尚无足够证据证明 TA与血栓栓塞事件有关。结论 TA可减少OPCAB手术患者的出血量和输血风

  8. Effect of combined therapy of danaparoid sodium and tranexamic acid on chronic disseminated intravascular coagulation associated with abdominal aortic aneurysm.

    Science.gov (United States)

    Ontachi, Yasuo; Asakura, Hidesaku; Arahata, Masahisa; Kadohira, Yasuko; Maekawa, Mio; Hayashi, Tomoe; Yamazaki, Masahide; Morishita, Eriko; Saito, Masanori; Minami, Shinji; Nakao, Shinji

    2005-09-01

    Chronic disseminated intravascular coagulation (DIC) is a well-known complication of aortic aneurysm. A 63-year-old man with bleeding tendency and a large palpable abdominal aortic aneurysm (AAA) was diagnosed as having fibrinolysis dominant DIC by the excessive activation of both coagulation and fibrinolysis (plasmin -alpha2 plasmin inhibitor complex concentration is usually >4 microg/ml). Although several treatments were tried, DIC could not be controlled until the patient was given combined therapy of danaparoid (1,250 U/12 h, bolus IV) and tranexamic acid (0.5 g x 3/day, oral administration). This therapy may be beneficial when control for bleeding is required without restricting the ambulatory movement of patients by continuous drip. PMID:16127203

  9. Kasabach-Merritt syndrome associated with giant liver hemangioma: the effect of combined therapy with danaparoid sodium and tranexamic acid.

    Science.gov (United States)

    Ontachi, Yasuo; Asakura, Hidesaku; Omote, Mika; Yoshida, Tomotaka; Matsui, Osamu; Nakao, Shinji

    2005-11-01

    n patients with Kasabach-Merritt syndrome (KMS), local activation of coagulation commonly results in disseminated intravascular coagulation (DIC). Progress of DIC is associated with 30-40% mortality as a result of uncontrollable hemorrhage. A 39-year-old woman with an enlarging giant liver hemangioma was diagnosed as having KMS with DIC. To control the hemorrhagic diathesis, we commenced combination therapy for DIC with danaparoid (1,250 Ux2/day, intravenously (IV)) and tranexamic acid (0.5 g x 3/day, peros (PO). Rapid improvement of the bleeding tendency and coagulopathy occurred in response to this treatment - that is, DIC was controlled without removing the giant hemangioma. The therapy did not restrict the behavior of the patient by continuous drip and angiography could be performed without bleeding. Such therapy may be beneficial in chronic DIC with activation of fibrinolysis. PMID:16266920

  10. Tranexamic acid combined with recombinant factor VIII increases clot resistance to accelerated fibrinolysis in severe hemophilia A

    DEFF Research Database (Denmark)

    Hvas, Anne-Mette; Sørensen, Hanne Thykjær; Norengaard, Lisbeth;

    2007-01-01

    BACKGROUND: Most patients with severe hemophilia A suffer from a profoundly compromised hemostatic response. In addition to both the delayed and slow development of a clot, previous studies have documented that severe hemophilia A is also associated with reduced clot stability. OBJECTIVES: We...... examined whether the clot stability in hemophiliacs could be improved by treatment with tranexamic acid (TXA) in combination with recombinant factor VIII (rFVIII). PATIENTS/METHODS: Baseline blood samples were obtained from eight males with severe hemophilia A. Thereafter, a bolus injection of r...... the elasticity curve increased 5-fold after rFVIII and 24-fold after addition of TXA. CONCLUSIONS: The study demonstrates that simultaneous treatment with TXA and rFVIII significantly improves the clot stability in patients with hemophilia A. Udgivelsesdato: December...

  11. ROLE OF TRANEXAMIC ACID IN REDUCING POSTOPERATIVE BLOOD LOSS AND TRANSFUSION REQUIREMENT IN PATIENTS UNDERGOING LOWER LIMB ORTHOPEDIC SURGERIES

    Directory of Open Access Journals (Sweden)

    Yashwant

    2014-09-01

    Full Text Available AIM: Aim of our study to assess the effects of tranexamic acid (TA in patients undergoing lower limb orthopedic surgeries. OBJECTIVE: Assess the effects of tranexamic acid on prevention of bleeding and requirement of blood transfusion after major lower limb orthopedic surgeries. MATERIAL AND METHOD: 90 patients ASA grade I & II undergoing elective surgery for femoral fracture like open reduction internal fixation, hemiarthroplasty, total hip replacement (THR under anaesthesia were taken. Patients were classified randomly into 2 groups (forty five patients in each group. Group T: Patients received inj. TA 10 mg/kg body weight. Group P: Patients received normal saline 1 ml/kg body weight 15 min before surgery. Postoperative hemoglobin concentration (on day 0 and day 2 and volume of blood in the drain were measured. The number of units of packed red cells transfused during the hospital stay was recorded and any thromboembolic and other complications were documented. RESULT: Analysis revealed that there were no significant differences between the patients with respect to age, sex, duration and type of surgery and preoperative mean hemoglobin concentration. Neither heart rate nor MABP has statistically significant difference or results (P>0.05. The drains were removed in the evening of the first postoperative day. Mean volume of blood in the drain compared to placebo group showing a highly significant reduction in postoperative blood loss (P=0.01. Mean fall in hemoglobin at day 0 and day 2 was 2 less in the study group as compared to the placebo that has P value 0.01 making it significant finding. CONCLUSION: the present paired study demonstrated that the administration of TA given preoperatively reduces the blood loss in the first 24 h by a highly significant degree as well it causes a significant reduction in postoperative anemia and need for transfusion among these patients.

  12. 氨甲环酸与抑肽酶对心脏手术血液保护的Meta分析%Effects of tranexamic acid and aprotinin on blood-conservation in heart surgery: a meta-analysis

    Institute of Scientific and Technical Information of China (English)

    叶博; 张国荣; 范勤; 曹晨; 魏国

    2011-01-01

    目的 系统评价氨甲环酸与抑肽酶在体外循环心脏手术中的血液保护效果.方法 检索Medline、PubMed、中国期刊全文数据库、中国生物医学文献数据库中氨甲环酸与抑肽酶对CPB心脏手术患者血液保护的随机对照研究文献,收集各研究中的血小板、凝血指标、血红蛋白、血细胞比容、术中出血量、术后24 h纵隔心包引流量、输血例数、术后并发症及术后近期死亡例数.计数资料采用优势比和95%可信区间表示,计量资料采用加权平均值和95%可信区间(CI)表示,所有计算和统计用RevMan 4.2.10软件完成,异质性检验采用χ2和I2完成.结果 符合标准的文献共16篇,3 393例患者.分析显示,与抑肽酶相比,氨甲环酸术后24 h纵隔心包引流量偏多(WMD=-65.28 CI:-103.92,-26.65 P=0.0009),但术后肾功能障碍患者例数明显较少(OR=1.36 CI:1.11,1.67 P=0.03),而血小板计数、凝血指标、血红蛋白值、术中出血量、成分输血例数均无显著差异(P>0.05).结论 在体外循环心脏手术中,氨甲环酸的血液保护效果比抑肽酶稍差,但其安全性能高,不易引起肾功能损害.%Objective To systematically evaluate the effect of tranexamic acid and aprotinin on blood conservation in open heart surgery with cardiopulmonary bypass.Methods A systematic overview and Meta - analysis were undertaken on all the randomized controlled trials of tranexamic acid and aprotinin in heart surgery from MEDLINE, PubMed, CNKI and CMB disk, with all the data as to platelets, coagulation indexes, hemoglobin ( Hb ), hematocrit ( Hct ), intraoperative hemorrhage volume, postoperative 24 h mediastinal pericardial drainage, cases of blood transfusion, postoperative complications and recent postoperative deaths.The weighted mean difference ( WMD ) with 95% confidence intervals ( CI ) for continuous data and odds ratio ( OR ) with 95% CI for dichotomous data were calculated.Statistical analysis was

  13. Effect of tranexamic acid on perioperative blood loss during transurethral resection of prostate%氨甲环酸对经尿道前列腺电切术失血量的影响

    Institute of Scientific and Technical Information of China (English)

    蒙倩倩; 熊君宇; 潘宁

    2014-01-01

    Objective To determine the effect of tranexamic acid on perioperative blood loss in patients who underwent transurethral resection of the prostate ( TURP) , as well as its safety.Methods A double blind randomized control trial was conducted from January 2012 to February 2013.In this trial, 30 patients of the tranexamic acid group (T group), between age of 55-85 years, underwent TURP and received 1 g of tranexamic acid in 200 mL normal saline after induction of anes-thesia and 30 patients of the control group (C group) received a placebo (normal saline only).The medicine dripping speed ranged 20-40 drops/minute.The amount of blood loss was measured during the operation and at 4 h and 24 h post-operatively and the difference between the two groups was analyzed.Coagulation profiles, including prothrombin time, thrombin time and fibrinogen level, were measured preoperatively and 4 h postoperatively.Any signs of thromboembolic e-vent especially in the lower limbs or within 7 days were noted.Results The blood losses during operation and 4 h postopera-tion were (102.0 ±11.4) mL and (61.9 ±6.1) mL, respectively in the T group and (303.6 ±24.8) mL and (84.8 ± 15.2) mL, respectively in the C group.The values were significantly lower in the T group compared to those in the C group (P<0.05).However, there was no significant difference at 24 h postoperative blood loss between the groups.The coagu-lation profiles in the two groups were statistically not relevant.There was no evidence of deep vein thrombosis in the lower limbs or in both groups.Conclusion Tranexamic acid can reduce intraoperative blood loss during TURP without increasing the risk of thrombosis.%目的:探讨人工合成的抗纤溶药物氨甲环酸对接受经尿道前列腺电切术的患者失血量的影响及其安全性。方法2012年1月—2013年2月行经尿道前列腺电切术的60例患者,随机双盲分为氨甲环酸组( T组)和空白对照组( C组),每组30例。 T组在麻

  14. 氨甲环酸用于非体外循环冠状动脉搭桥术血液保护作用的Meta分析%The Blood Preservation Effect of Tranexamic Acid in Off-pump Coronary Bypass Graft Surgery: A Meta-analysis

    Institute of Scientific and Technical Information of China (English)

    王古岩; 杜英杰; 杨丽静; 吉冰洋; 郑哲

    2013-01-01

    目的 采用系统回顾和Meta分析评价氨甲环酸用于非体外循环冠状动脉搭桥术(OPCAB)的血液保护效果及安全性.方法 全面检索Pubmed、Coehrane CENTRAL、EMBASE数据库,将行OPCAB术患者,分为氨甲环酸组和对照组进行比较,报道了至少一项明确临床结果的所有随机临床试验均纳入本Meta分析,日期截止至2012年1月.使用Review Manager 5.1统计学软件行Meta分析,计数资料计算优势比(OR)和95%可信区间(CI),连续变量计算加权均数差(WMD)和95%CI.结果 共10项随机临床试验中的849例病人纳入该Meta分析.在OPCAB术中,同对照组相比,氨甲环酸可明显减少病人24h的胸腔引流量(WMD-209ml,95%CI:-310ml~-107ml,p<0.001),并显著降低异体红细胞(OR 0.46,95%CI:0.33~0.63,p<0.001)和新鲜冰冻血浆(OR 0.30,95%CI:0.18~0.51,p< 0.001)的使用率.两组病人术后严重栓塞并发症(包括急性心肌梗死、中风和肺栓塞)和肾功能衰竭的发生率,以及ICU停留时间、住院时间均无显著差别.结论 现有证据表明OPCAB术应用氨甲环酸可减少术后出血量,减低异体血使用率,有明确的血液保护作用.%Objective To determine the blood preservation efficacy and safety of tranexamic acid for off-pump coronary bypass graft (OPCAB) surgery by systematic review and meta-analysis. Methods A comprehensive search was undertaken to identify all randomized trials of tranexamic acid in OPCAB surgery. Pubmed, Cochrane CENTRAL and EMBASE databases were searched up to January 2012. All randomized trials comparing tranexamic acid and placebo in OPCAB surgery and reporting at least one predefined clinical outcome were included. Meta-analysis was conducted using the Cochrane Collaboration' s Revman 5.1 software. The odd radio (OR and confidence intervals [CI]) and weighted mean differences (WMD, 95% CI) were calculated for dichotomous and continuous vaviables, respectively. Results Ten randomized trials

  15. 拉曼光谱快速检测氨甲环酸注射液%Rapid Raman spectra identification and determination of Tranexamic acid injection

    Institute of Scientific and Technical Information of China (English)

    刘惠军; 吴丽红; 张继春; 傅莉萍

    2013-01-01

    OBJECTIVE To develop a method for the rapid identification,test and determine of Tranexamic acid injection using Raman spectra.METHODS Raman spectra was used to identify,test and determine the Tranexamic acid injection.RESULTS The result showed that the method of Raman spectra could identify,check pH value and determinate the Tranexamic acid injection.CONCLUSION Owing to its fast and nondestructive properties,the presented method can be developed as a analysis method for injection.%目的 运用拉曼光谱技术快速鉴别、检查和测定氨甲环酸注射液.方法 以氨甲环酸原料及注射液为研究对象,应用拉曼光谱方法快速检测氨甲环酸.结果 拉曼光谱方法可以鉴别氨甲环酸注射液,并进行pH值检查和含量测定.结论 所用方法操作简便、快速,可发展成为注射剂快速检测的分析方法.

  16. 氨甲环酸与纤维蛋白胶在关节置换术后疗效比较的 Meta分析%Comparison of effect between tranexamic acid versus fibrin sealant after joint arthroplasty:a Meta-analysis

    Institute of Scientific and Technical Information of China (English)

    饶烽; 丁浩; 王琰; 陈福宇; 史晨辉; 王维山

    2016-01-01

    目的:比较氨甲环酸与纤维蛋白胶在关节置换术中应用的有效性和安全性。方法通过检索PubMed,Embase, Cochrane Library ,CNKI ,CBM ,万方等数据库有关关节置换术应用氨甲环酸和纤维蛋白胶的文献,由2位研究者按照纳入和排除标准独立筛选文献,采用Rev M an 5.2软件对提取的数据进行统计学分析。结果共纳入4个随机对照试验,2个回顾性试验,共449例患者。Meta分析结果显示:氨甲环酸与纤维蛋白胶在总失血量上差异无统计学意义[MD=—192.24,95% CI(—496.16,111.69),P=0.22],血红蛋白丢失量差异无统计学意义[MD=—0.49,95% CI (—1.19,0.20),P=0.16],输血率差异具有统计学意义[OR=0.30,95% CI (0.18,0.52),P<0.01],术后并发症差异无统计学意义[OR=1.20,95% CI (0.36,3.99),P=0.76]。结论氨甲环酸在控制关节置换术术后输血率方面比纤维蛋白胶更加有效。%Objective To compare the effectiveness and safety of tranexamic acid and fibrin sealant in joint arthroplasty . Methods The literatures on the application of tranexamic acid and fibrin sealant in joint arthroplasty were retrieved from PubMed , Embase ,Cochrane Library ,CNKI and other internet databases .Two reviewers independently screened the literatures according to the inclusion and exclusion standard .The RevMan 5 .2 software was adopted to conduct the statistical analysis on the extracted da‐ta .Results Four randomized controlled trials(RCTs) and 2 retrospective experiments were included ,involving 449 patients .The meta analysis results showed that tranexamic acid and fibrin sealant had no statistically significant difference in total blood loss[MD= -192 .24 ,95% CI(-496 .16 ,111 .69) ,P=0 .22] and hemoglobin loss amount[MD= -0 .49 ,95% CI(-1 .19 ,0 .20) ,P=0 .16] , had statistically significant difference in the blood transfusion rate[OR=0 .30 ,95% CI(0 .18 ,0

  17. Co-drug strategy for promoting skin targeting and minimizing the transdermal diffusion of hydroquinone and tranexamic acid.

    Science.gov (United States)

    Hsieh, Pei-Wen; Chen, Wei-Yu; Aljuffali, Ibrahim A; Chen, Chun-Che; Fang, Jia-You

    2013-01-01

    Hydroquinone and tranexamic acids (TXA) are skin-lightening agents with a hydrophilic nature and low skin absorption. A high dose is needed for clinical use, resulting in a high incidence of skin irritation. Co-drugs formed by conjugating hydroquinone and TXA were synthesized and their in vitro and in vivo skin absorption characteristics were evaluated. The two synthesized co-drugs were 4-hydroxyphenyl 4-(aminomethyl)cyclohexanecarboxylate (HAC) and 1,4- phenylene bis(aminomethyl)cyclohexanecarboxylate (BAC). The co-drugs were chemically stable in aqueous solution, but rapidly degraded to the respective parent drug in esterases and skin homogenates. Compared to hydroquinone application, 7.2- and 2.4-fold increments in the hydroquinone skin deposition were obtained with the in vitro application of HAC and BAC. HAC and BAC led to 3- and 2-fold enhancements of equivalent TXA deposition compared to TXA administration. The in vivo experiment showed a further enhancement of co-drugs compared to the in vitro setup. The transdermal penetration of co-drugs, especially BAC, was much lower than that of hydroquinone and TXA. This indicated high-level skin targeting by the co-drugs. HAC and BAC revealed strong affinities for the viable epidermis/dermis. Hair follicles are important reservoirs for co-drug delivery. Daily administration of co-drugs to the skin did not generate irritation for up to 7 days. Both co-drugs are superior candidates for treating skin hyperpigmentation.

  18. Co-drug strategy for promoting skin targeting and minimizing the transdermal diffusion of hydroquinone and tranexamic acid.

    Science.gov (United States)

    Hsieh, Pei-Wen; Chen, Wei-Yu; Aljuffali, Ibrahim A; Chen, Chun-Che; Fang, Jia-You

    2013-01-01

    Hydroquinone and tranexamic acids (TXA) are skin-lightening agents with a hydrophilic nature and low skin absorption. A high dose is needed for clinical use, resulting in a high incidence of skin irritation. Co-drugs formed by conjugating hydroquinone and TXA were synthesized and their in vitro and in vivo skin absorption characteristics were evaluated. The two synthesized co-drugs were 4-hydroxyphenyl 4-(aminomethyl)cyclohexanecarboxylate (HAC) and 1,4- phenylene bis(aminomethyl)cyclohexanecarboxylate (BAC). The co-drugs were chemically stable in aqueous solution, but rapidly degraded to the respective parent drug in esterases and skin homogenates. Compared to hydroquinone application, 7.2- and 2.4-fold increments in the hydroquinone skin deposition were obtained with the in vitro application of HAC and BAC. HAC and BAC led to 3- and 2-fold enhancements of equivalent TXA deposition compared to TXA administration. The in vivo experiment showed a further enhancement of co-drugs compared to the in vitro setup. The transdermal penetration of co-drugs, especially BAC, was much lower than that of hydroquinone and TXA. This indicated high-level skin targeting by the co-drugs. HAC and BAC revealed strong affinities for the viable epidermis/dermis. Hair follicles are important reservoirs for co-drug delivery. Daily administration of co-drugs to the skin did not generate irritation for up to 7 days. Both co-drugs are superior candidates for treating skin hyperpigmentation. PMID:23931279

  19. Evaluations of topical application of tranexamic acid on post-operative blood loss in off-pump coronary artery bypass surgery

    OpenAIRE

    Habibollah Hosseini; Ali Akbar Rahimianfar; Mohammad Hassan Abdollahi; Mohammad Hossein Moshtaghiyoon; Mahdi Haddadzadeh; Asefeh Fekri; Kazem Barzegar; Fatemeh Rahimianfar

    2014-01-01

    Objective: One of the major complications of cardiac surgery is the presence of post-operative bleeding. The aim of the present study was to investigate the topical application of tranexamic acid in the pericardial cavity on post-operative bleeding in off-pump coronary artery bypass graft (CABG) surgery. Materials and Methods: This study was on 71 patients who underwent off-pump CABG. The anesthesia and surgery methods were the same for all patients. Patients were assigned to two equal groups...

  20. 氨甲环酸结合术后引流管临时夹闭降低单侧全膝置换术后失血量的有效性及安全性%Use of intravenous tranexamic acid combined with temporary clamping of drain reduce postoperative blood loss in total knee arthroplasty

    Institute of Scientific and Technical Information of China (English)

    彭慧明; 翁习生; 翟吉良; 金今; 林进; 钱文伟; 左宇志; 赵丽娟

    2014-01-01

    Objective To evaluate the efficacy and safety of one dose tranexamic acid combined with temporary drain lamping in primary unilateral total knee arthroplasty (TKA).Methods In a randomized,double-blind,placebo-controlled trial,90 patients were randomized to receive 15 mg/kg of tranexamic acid or an equivalent volume of placebo (normal saline solution) 15 min before the tourniquet deflated.Both groups were combined with drain lamping for 4 h.The first 12 h drainage,total drainage,blood transfusion rate,postoperative 1 d,3 d,5 d hemoglobin,hematocrit,postoperative 24 h D-dimer,incidence of lower limb ecchymosis and postoperative complications were recorded.Doppler ultrasound applied in all patients 5-7 days postoperation to evaluate the incidence of deep vein thrombosis.Results Seventy-seven patients were included in the intention-to-treat analysis (39 cases in tranexamic acid group and 38 cases in placebo group).The demographic data was well matched in both groups.The mean drainage in the first 12 hours (142.6±202.1 ml),total blood loss (962.2±286.2 ml),and hidden blood loss (685.4±40.3 ml) was reduced in the tranexamic acid group in comparison with the placebo group (257.4±245.3 ml; 1168.4±455.4 ml; 834.3±200.0 ml).The postoperative 3 d hemoglobin levels were higher in the tranexamic acid groups (104.0± 12.7 g/L) in comparison with the placebo group (96.0±13.4 g/L).The incidence of postoperative lower limb ecchymosis was lower in tranexamic acid group (2.6%,1/ 39) in comparison with the placebo group (18.4%,7/38).There was no significant difference in total drainage,rates of transfusion,incidence of deep vein thrombosis or pulmonary embolism between the two groups.Conclusion Application of intravenous infusion of 15 mg/kg tranexamic acid 15 min before the tourniquet deflated combined with 4 h drain lamping in TKA is effective and safe.%目的 评估单次静脉应用氨甲环酸结合术后引流管临时夹闭降低单侧全膝关节置换(total knee

  1. Prospective comparative research on blood loss after total hip arthroplasty between single dose intraarticular injection of tranexamic acid and during operation and postoperative injection of tranexamic acid%氨甲环酸止血对全髋关节置换术围术期失血量影响

    Institute of Scientific and Technical Information of China (English)

    华政哲; 张敬东; 韩文峰; 何勇; 张攀; 孙保飞

    2015-01-01

    目的 评价术中髋臼及股骨髓腔创面应用氨甲环酸止血同时在关闭切口后经引流管髋关节腔内单次灌注应用氨甲环酸止血和关闭切口后经引流管髋关节腔内单次灌注应用氨甲环酸止血对全髋关节置换围手术期失血量的影响. 方法前瞻性研究分析自2014年1月至2015年1月收治的64例因股骨头坏死行全髋关节置换术患者,按治疗方法不同分为A组和B组. A组患者32例:关闭切口后,经引流管髋关节腔内单次灌注氨甲环酸2. 5 g(25 ml)止血. B组患者32例:术中髋臼及股骨髓腔创面分别应用0. 5 g(5 ml)氨甲环酸浸润,并用纱布填塞止血,同时在关闭切口后经引流管髋关节腔内单次灌注1. 5 g(15 ml)氨甲环酸止血. 两组患者均由同一术者、同一术式完成全髋关节置换. 比较两组患者手术时间、术中失血量、术后引流量、术后血红蛋白变化和总失血量. 结果 术后24 h,A组患者血红蛋白为(10. 4 ±0. 8)g/L,B组(11. 6 ±0. 9)g/L,两组间比较差异有统计学意义(P0. 05). 两组患者术后均未发生假体周围感染、下肢深静脉血栓或其他并发症. 结论 全髋关节置换术中,髋臼及股骨髓腔创面应用氨甲环酸止血同时,在关闭切口后经引流管髋关节腔内局部灌注氨甲环酸止血,较关闭切口后经引流管髋关节腔内单次灌注氨甲环酸止血效果更好,并且不增加手术时间、假体周围感染及静脉血栓形成的风险.%Objective To explore the efficiency of single dose intra-articular injection of tranexamic acid( TXA) and during operation and postoperative injection of tranexamic acid on the blood loss after total hip arthroplasty(THA). Methods A total of 64 patients with necrosis of femoral head,who were performed THA,were prospective analyzed. Due to the TXA control method,patients were ran-dom divided into two groups including single dose intra-articular injection of tranexamic acid group( A group

  2. Prophylactic use of tranexamic acid combined with thrombelastogram guided coagulation management may reduce blood loss and allogeneic transfusion in pediatric hemispherectomy: case series.

    Science.gov (United States)

    Xiao, Wei; Fu, Wenya; Wang, Tianlong; Zhao, Lei

    2016-09-01

    Hemispherectomy is an established surgical procedure to treat medically refractory epilepsy caused by diffuse hemispheric diseases. The most common complication of hemispherectomy is intraoperative bleeding. Perioperative allogeneic blood transfusion increases mortality and morbidity in pediatric patients. Etiologies of massive blood loss during hemispherectomy include intraoperative diffuse vascular damage, antileptic drugs induced coagulation dysfunction, hyperfibrinolysis and dilutional coagulopathy. Great efforts should be made to minimize the need of blood transfusion. We present a series of three cases undergoing pediatric hemispherectomy, where a new algorithm was employed to manage coagulation. This new algorithm was mainly based on timely thrombelastogram analyses guided clotting factors supplement and continuous administration of tranexamic acid. In our cases, the amount of blood loss and subsequent allogeneic blood transfusion seemed to be less than literature reported. PMID:27555151

  3. 氨甲环酸在脊柱矫形手术中的应用%Application of Tranexamic Acid in Major Spinal Surgery

    Institute of Scientific and Technical Information of China (English)

    刘洪秀; 思永玉

    2011-01-01

    较大脊柱手术的病人常常需要大量的输血.抗纤维蛋白溶解药的使用可以减少心脏外科和全膝关节置换手术的输血.但合成的抗纤维蛋白溶解药,如氨甲环酸(tranexamic acid)在减少脊柱手术输血量的作用仍不明确.脊柱手术的病人使用这类药的研究和报道是少见的.本综述的目的是简要的讨论氨甲环酸(TXA)的药理学,抗纤维蛋白溶解药潜在的风险和优点.

  4. Prospective comparative research on the blood loss after total knee arthroplasty be-tween single dose intraarticular injection of tranexamic acid and during operation and postoperative injection of tranexamic acid%氨甲环酸应用方式对膝关节置换围手术期失血量影响对照研究

    Institute of Scientific and Technical Information of China (English)

    华政哲; 张敬东; 韩文峰; 何勇; 张攀; 孙保飞

    2016-01-01

    Objective To compare the efficiency of single dose intra-articular injection of tranexamic acid( TXA) and during operation and postoperative injection of tranexamic acid on the blood loss after total knee arthroplasty( TKA) . Meth-ods A total of 68 patients with osteoarthritis of knee joint,who were performed TKA,were prospective analyzed. Due to the TXA control method,patients were random divided into two groups including single dose intra-articular injection of tranex-amic acid group(Group A)and in operation and postoperative injection of tranexamic acid group(Group B). In Group A, 2. 5 g tranexamic acid was intra-articular injected after skin suture. In Group B,1. 0 g tranexamic acid was injected to femo-ral medullary cavity in operation,and the other 1. 5 g tranexamic acid was intra-articular injected after skin suture. All oper-ations in the two groups were performed by the same surgeon,and the same knee joint prosthesis. The data of hemoglobin, operation time,drainage blood and total blood loss after TKA were analyzed. Results There were no significant difference between two groups with respect of age,gender,body mass index. At 24 hours postoperatively,the hemoglobin in Group A was(11. 2 ± 0. 9)g/L,and(11. 9 ± 0. 8)g/L in Group B,and there was significant difference between the two groups. At 48 hours postoperatively,the hemoglobin of Group A was(10. 5 ± 1. 0) g/L,and that was(11. 3 ± 0. 6) g/L in Group B,and there was significant difference between the two groups. The postoperative drainage volume was(320. 5 ± 21. 0)ml in Group A and(260. 9 ±18. 7)ml in Group B,and there was significant difference between the two groups(P<0. 01). The total blood loss was(962. 0 ±43. 6)ml in Group A and(780. 0 ±42. 3)ml in Group B,and there was also significant difference between the two groups(P<0. 01). No case suffered from deep vein thrombosis and other complications in both groups. Conclusion Combined with intraoperative and postoperative injection of tranexamic

  5. Clinical Trials

    Science.gov (United States)

    Clinical trials are research studies that test how well new medical approaches work in people. Each study answers ... prevent, screen for, diagnose, or treat a disease. Clinical trials may also compare a new treatment to a ...

  6. 荟萃分析氨甲环酸治疗特发性月经过多的疗效%Meta-analysis of Tranexamic Acid in the Treatment of Idiopathetic Menorrhagia

    Institute of Scientific and Technical Information of China (English)

    沈岚; 刘玲; 蒋希菁

    2012-01-01

    OBJECTIVE To review the quality of studies about the treatment of tranexamic acid in idiopathetic menorrhagia systematically and meta-analyze the effect of tranexamic acid on idiopathetic menorrhagia. METHODS Collected all the studies about the treatment of tranexamic acid in idiopathetic menorrhagia, then evaluated their qualities by using the Jadad scale. Finally, compared the efficacy and safety of tranexamic acid with placebo, progesterone and non-steroidal drugs in the treatment of idiopathetic menorrhagia. RESULTS According to the inclusion and exclusion criteria, a total of eight articles were include in this study, seven of them were English literatures and one was Chinese. The proportion of high quality articles was 87.5%. All the drugs used in these articles could reduce the bleeding of patients with idiopathetic menorrhagia. However, on the reduction in loss, treatment efficiency and the improvement ratio of patient feel, the effect of tranexamic acid was significantly higher than placebo and other drug group. Tranexamic acid didn't change the length of the patient's menstrual period, and the proportion of adverse reactions was significantly lower than progesterone drugs. CONCLUSION Tranexamic acid is a safe and effective drug for the treatment of idiopathetic menorrhagia. However, because the number of literatures rolled in this study was small, there is a certain bias, which needed further research.%目的 系统评价氨甲环酸治疗特发性月经过多文献的质量,荟萃分析氨甲环酸治疗特发性月经过多的疗效.方法 全面收集关于氨甲环酸治疗月经过多的相关文献,并根据改良Jadad量表严格评价文献质量,用RevMan 4.2荟萃分析软件分析比较氨甲环酸与安慰剂、孕激素类药物及非甾体类药物治疗月经过多的有效性与安全性.结果 根据纳入与排除标准对收集到的文献进行筛选,共有8篇文献纳入本次研究,其中英文文献7篇,中文文献1

  7. 氨甲环酸在全膝关节置换术中的应用进展%Application of tranexamic acid in total knee arthroplasty

    Institute of Scientific and Technical Information of China (English)

    吴洁; 陈晓勇; 朱锦宇

    2016-01-01

    全膝关节置换术(total knee arthroplasty,TKA)如今被应用的日益广泛,但是该手术围手术期常常会有大量出血而严重影响术后恢复.抗纤溶药物氨甲环酸(tranexamic acid,TXA)作为近年来许多学科纷纷采用的安全有效的止血剂,在国内外诸多研究中被证明在全膝关节置换术中应用也能安全有效的减少出血,从而减少输血率.本文拟对TKA围手术期使用TXA的血液保护机制、有效性、安全性、给药途径、给药剂量以及给药时机等加以综述.

  8. Tranexamic acid reduces blood loss and need of blood transfusion in total knee arthroplasty: A prospective, randomized, double-blind study in Indian population

    Directory of Open Access Journals (Sweden)

    Abhishek Shinde

    2015-01-01

    Full Text Available Introduction: For quite a few years, tranexamic acid (TEA has been used during total knee arthroplasty (TKA to reduce blood loss. However, no consensus exits regarding its timing and doses. Materials and Methods: We conducted a prospective, randomized double-blinded study of 56 patients in the Indian population undergoing TKA from 2011 to 2012. A dose of 10 mg/kg body weight of TEA (three doses was given in one group and normal saline was administered in the other. Results: The mean blood loss in the TEA unilateral group was 295 mL ± 218 mL and in the placebo group was 482 mL ± 186 mL (P < 0.005. In the bilateral TEA group, the mean blood loss was 596 mL ± 235 mL and in the placebo group was 1349 mL ± 41 mL (P < 0.005. Conclusion: The number of patients requiring blood transfusion reduced substantially. There was no increase in the risk of deep vein thrombosis (DVT and pulmonary embolism. TEA reduces intraoperative and postoperative blood loss and thus reduces the need of allogenic blood transfusion.

  9. Intra-articular injection of tranexamic acid via a drain plus drain-clamping to reduce blood loss in cementless total knee arthroplasty

    Directory of Open Access Journals (Sweden)

    Mutsuzaki Hirotaka

    2012-09-01

    Full Text Available Abstract Background Patients undergoing cementless total knee arthroplasty (TKA sometimes suffer large blood loss. In a retrospective study, we explored whether postoperative intra-articular retrograde injection of tranexamic acid (TA and leaving a drain clamp in place for 1 h reduced blood loss. Patients and methods Patients (n = 140 treated with unilateral primary cementless TKA (posterior cruciate ligament retained were divided into two groups: those who had an intra-articular injection of TA (1000 mg and drain clamping for 1 h postoperatively (study group, n = 70 and those who were not given TA and did not undergo clamping of their drains (control group, n = 70. Postoperative total blood loss, volume of drainage, hemoglobin level, transfusion amounts and rates, D-dimer level at postoperative day (POD 7, and complications were recorded. Results Total blood loss, total drainage, mean transfusion volume, and transfusion rates were lower in the study group than in controls (P P P  Conclusions Immediately postoperative intra-articular retrograde injection of TA and 1 h of drain-clamping effectively reduced blood loss and blood transfusion after cementless TKA. We believe that this method is simple, easy, and suitable for these patients.

  10. Tranexamic Acid in a Multimodal Blood Loss Prevention Protocol to Decrease Blood Loss in Revision Total Knee Arthroplasty: A Cohort Study#

    Science.gov (United States)

    Ortega-Andreu, Miguel; Talavera, Gloria; Padilla-Eguiluz, Norma G.; Perez-Chrzanowska, Hanna; Figueredo-Galve, Reyes; Rodriguez-Merchán, Carlos E.; Gómez-Barrena, Enrique

    2016-01-01

    Purpose: To clarify if blood loss and transfusion requirements can be decreased in revision knee surgery through a multimodal blood loss approach with tranexamic acid (TXA) Patients and Methods: A retrospective study was designed in 87 knees (79 patients) that received a knee revision between 2007 and 2013. To avoid heterogeneity in the surgical technique, only revisions with one single implant system were included. A treatment series of 44 knees that received TXA and other techniques in a multimodal blood loss protocol was compared to a control series of 43 knees that received neither TXA nor the rest of the multimodal blood loss protocol. No differences in the complexity of surgeries or case severity were detected. Results: A significant decrease was observed from 58% transfusion rate in the control group to 5% in the treated group. The postoperative haemoglobin drop was also significantly different. Although the use of a blood loss prevention approach including TXA was the most relevant factor in the transfusion risk (OR=15), longer surgical time also associated an increased risk of transfusion (OR=1.15). Conclusion: This study supports the use of a two-dose intravenous TXA under a multimodal blood loss prevention approach in revision knee replacement with significant reduction in the transfusion rate, postoperative blood loss and haemoglobin drop.

  11. 氨甲环酸治疗黄褐斑的研究进展%Research progress of tranexamic acid in treatment of chloasma

    Institute of Scientific and Technical Information of China (English)

    李健和; 胡焰; 赵子影; 刘新义; 彭六保; 易利丹

    2013-01-01

    More and more clinical studies have shown that oral and (or) local administration of tranexamic acid as either monotherapy or adjunctive therapy is effective and safe for chloasma patients.The mechanism of its action is related with tyrosinase.It may interfere with the catalysis of tyrosinase by producing competition with tyrosine directly or may inhibit melanin synthesis in melanocytes by interfering with the interaction of melanocytes and keratinocytes for reducing the activity of tyrosinase through inhibition of the plasminogen/plasmin system.%越来越多的临床研究表明,口服和(或)局部给予氨甲环酸治疗黄褐斑疗效良好,不良反应小,可单独或联合其他药物或方法进行治疗.其作用机制与酪氨酸酶相关,可能直接与酪氨酸竞争,干扰酪氨酸酶对酪氨酸代谢的催化作用;也可能通过抑制纤溶酶原-纤溶酶系统干扰黑色素细胞和角化细胞的相互作用,降低酪氨酸酶的活性,从而抑制黑色素细胞黑色素的合成.

  12. Acido tranexâmico e hemostasia em cirurgia de revascularização do miocárdio com circulação extracorpórea Tranexamic acid and hemostasis in myocardial revascularization with extracorporeal circulation

    Directory of Open Access Journals (Sweden)

    Guilherme F Vargas

    1992-12-01

    Full Text Available O antífibrinolítico sintético ácido tranexâmico (Transamin ® foi avaliado em seus efeitos hemostáticos e poupadores de transfusões homólogas, em pacientes submetidos a revascularização do miocárdio com circulação extracorpórea (CEC. Quarenta pacientes receberam placebo e 55 pacientes foram operados sob o efeito do ácido tranexâmico na dose de 10 g endovenosa no trans-operatório (2 g administrados na indução anestésica e os restantes 8 g nas 4 horas seguintes de cirurgia, de modo contínuo. O ácido tranexâmico, na dosagem utilizada, demonstrou possuir efeito hemostático impressionante, promovendo uma redução no débito pelos drenos torácicos da ordem de 47% nas 12 horas de P.O., 42,5% nas 24 horas de P. O. e 40,5% até a retirada dos drenos, em relação ao grupo-controle (pThe synthetic antif ibrinolytic drug tranexamic acid was evaluated in its hemostatic and blood saving effects, in patients submitted to myocardial revascularization with extracorporeal circulation. To 40 patients were administered placebo and to 55 tranexamic acid I.V. in a dosage of 10 g in the operative period (2 g in the anesthetic induction and the remaining 8 g in a continuous way during the operative procedure. Tranexamic acid, in this dosage, has proved to have a very impressive hemostatic effect, leadir g to a reduction in post operative bleeding of 47% in 12 h, 42,5% in 24 h and 40,5% when drains were taken off, related to the control group (p < 0.05. Tranexamic acid have led to less utilization for homologous paked red cells per patient, but statistical significance was found only in the 24 h of post operative period, with 1,025 units/patient in control group and 0,333 units/ patient in treated group. Concerning post operative complications, there have been more neurological alterations without sequelae (2.5% against 12.7% and creatinin alterations (5% against 10.9% in the tranexamic acid group. Such alterations were attributed to the high

  13. 膝关节置换术前、术后使用氨甲环酸的临床观察%Clinical observation of tranexamic acid applied before and after the total knee arthroplasty

    Institute of Scientific and Technical Information of China (English)

    任厚相; 叶川; 刘日光; 王建吉; 孙琦

    2015-01-01

    目的:探讨膝关节置换术前、术后使用氨甲环酸的临床效果。方法:收治行全膝关节置换手术患者60例,随机分成试验组与对照组,各30例。试验组给予氨甲环酸,比较两组的临床效果。结果:试验组术后失血量与隐性失血量以及输血量均明显少于对照组(P<0.05)。结论:膝关节置换术前、术后使用氨甲环酸可以显著减少患者的失血量与输血量。%Objective:To explore the clinical effect of tranexamic acid applied before and after the total knee arthroplasty.Methods:60 cases of patients with total knee arthroplasty were randomly divided into the experimental group and the control group,with 30 cases in each group.The experimental group were given tranexamic acid.The clinical effect of the two groups were compared. Results:The postoperative blood loss and hidden blood loss and blood transfusion volume of the experimental group were significantly lower than those of the control group(P<0.05).Conclusion:Tranexamic acid applied before and after the total knee arthroplasty could reduce the blood loss and blood transfusion volume significantly.

  14. Q开关1064 nm激光联合氨甲环酸治疗黄褐斑的临床分析%Analysis Clinical of 1064 nm Laser Switch Q Combine With Tranexamic Acid Treatment of Chloasma.

    Institute of Scientific and Technical Information of China (English)

    高微

    2015-01-01

    目的:分析Q开关1064 nm激光联合氨甲环酸治疗黄褐斑的临床价值。方法选取2014年6月~2014年12月我院收治的60例黄褐斑患者为研究对象,将其随机分为观察组和对照组。观察组给予Q开关1064 nm激光联合氨甲环酸治疗,对照组仅给予Q开关1064 nm激光治疗,比较两组临床治疗效果。结果观察组总有效率高于对照组, P<0.05,差异具有统计学意义。结论Q开关1064 nm激光联合氨甲环酸治疗黄褐斑的临床价值显著。%Objective Analyze the clinical value of 1064 Q switch nm laser combined with tranexamic acid in the treatment of chloasma. Methods Selected 60 cases with chloasma from June 2014 to December 2014 in our hospital as the research object, divided into the observation group and the control group randomly. The observation group was given 1 064 nm laser Q switch combined with tranexamic acid treatment, the control group only received 1 064 nm laser Q switch treatment, compared clinical curative effect of two groups. Results The total effective rate of observation group was higher than that of the control group, P<0.05, had difference statistically signiifcance. Conclusion The clinical value of 1 064 nm laser Q switch combine with tranexamic acid in the treatment of chloasma is signiifcant.

  15. Application and safety of tranexamic acid in total knee arthroplasty%氨甲环酸在全膝关节置换中的应用及安全性

    Institute of Scientific and Technical Information of China (English)

    林业; 张国梁; 王跃文

    2016-01-01

    BACKGROUND:Studies suggested that blood loss was great during total knee arthroplasty, even blood transfusion was needed. Application of the tourniquet wil destroy the coagulation system, and is not conducive to hemostasis after replacement. Recently, tranexamic acid has been extensively used to reduce blood loss during total knee arthroplasty, because of low price, simple administration pathway, and effective effects on hemostasis. OBJECTIVE:To summarize the application and safety of tranexamic acid in total knee arthroplasty. METHODS:The first author retrieved PubMed and Chinese Journal Ful Text Database for articles from inception to October 2015. The key words were tranexamic acid, total knee arthroplasty, hemorrhage. More than 200 articles were retrieved, and finaly 50 articles met the inclusion criteria. RESULTS AND CONCLUSION:Tranexamic acid is a fibrinolytic inhibitor, can reversibly block the binding of plasminogen to fibrin, effectively inhibit fibrinolysis, and reduce hemorrhage after total knee arthroplasty. Nevertheless, there were significant differences in the use, dose and effect of tranexamic acid on hemostasis among different studies. Tranexamic acid was an effective drug for hemostasis during total knee arthroplasty. During total knee arthroplasty, tranexamic acid had been used to reduce dominant blood loss and hidden blood loss after arthroplasty, and could not increase the risk for venous thrombosis of lower limb. Currently, the timing of use, dosage, route of administration, and possible complications of tranexamic acid remain controversial.%背景:研究表明全膝关节置换出血量往往较大,甚至需要输血。而止血带的应用会破坏纤溶/凝血系统,不利于置换后伤口止血。近几年来,氨甲环酸由于低廉的使用价格、简单的给药途径、超高的止血效价被广泛应用于减少全膝关节置换失血。目的:综述近年国内外氨甲环酸在全膝关节置换中的应用效果及

  16. Application of tranexamic acid in perioperative period of total hip arthroplasty%氨甲环酸在全髋关节置换围手术期的应用

    Institute of Scientific and Technical Information of China (English)

    许德慧

    2016-01-01

    ObjectiveTo investigate clinical effect by tranexamic acid applied in perioperative period of total hip arthroplasty (THA).MethodsA total of 65 THA patients were randomly divided into treatment group with 33 cases and control group with 32 cases. The treatment group received 1 g tranexamic acid with 100 ml normal saline by intravenous drip before operation, followed by temporary drainage tube closure for 3 h after operation and then repeated administration of tranexamic acid. The control group received no hemostasis drug, along with normal drainage after operation. Comparison was made on intraoperative bleeding volume, postoperative drainage volume and total bleeding volume between the two groups, and observation was made on thrombus-related complications. ResultsThe treatment group had all less intraoperative bleeding volume, incision drainage volume and total bleeding volume than the control group, and their differences all had statistical significance (P<0.05). No thromboembolism as complications occurred in the two groups.ConclusionApplication of tranexamic acid in perioperative period of THA can precisely reduce bleeding volume in operation, along with satisfactory clinical effect.%目的:探讨氨甲环酸在全髋关节置换(THA)围手术期应用的临床效果。方法65例行THA患者,随机分为治疗组33例与对照组32例。治疗组患者在开皮前将氨甲环酸1 g 溶于100 ml生理盐水中静脉滴注,术后临时夹闭引流管3 h,术后3 h重复上述方法应用氨甲环酸1次;对照组不给予止血药物,术后正常引流。比较两组术中出血量、术后引流量及手术总失血量,观察血栓相关并发症的发生情况。结果治疗组术中出血量、切口引流量及手术总失血量均少于对照组,差异均具有统计学意义(P<0.05);术后两组无血栓栓塞等并发症发生。结论 THA围手术期使用氨甲环酸能有效减少手术失血量,临床效果满意。

  17. Tranexamic Acid renovate skin texture in damaged skin%氨甲环酸对损伤后皮肤纹理的修复作用

    Institute of Scientific and Technical Information of China (English)

    袁超; 王学民; 谈益妹; 杨丽洁; 高延瑞

    2013-01-01

    Objective To determine whether or not Tranexamic Acid (TA) could renovate skin texture in damaged skin. Methods Two kinds of damaged skin models were set up and subjected to the repeated application of SLS (sodium lauryl sulfate) and irradiation of UVB (ultraviolet B). TA -induced changes in skin were detected by Visioscan 98. Results After 3, 7 and 14 days of application, TA can significantly increase all the Texture Parameters in SLS application, and only increase the Energy in UVB irradiation. TA could improve the SESM and SEW in two damaged skin models. Conclusion These experiments suggest that TA can significant improve skin texture in damaged skin.%目的:探讨氨甲环酸对化学损伤和物理损伤后皮肤纹理的修复作用.方法:5% SLS溶液反复涂抹形成化学损伤模型,3MED照射后形成物理损伤模型.两种不同皮肤损伤模型同时应用5%氨甲环酸水溶液进行涂抹.应用皮肤扫描仪对氨甲环酸组和自我修复组的皮肤纹理改变进行14天观察.结果:氨甲环酸可有效改善化学损伤后质地参数,物理损伤中仅可改善NRJ;氨甲环酸可改善两种损伤后的皮肤表面光滑度和细纹.结论:氨甲环酸在14天内对因化学或物理损伤引起的皮肤表面纹理有显著改善作用.

  18. 氨甲环酸在人工关节外科领域的应用%Application of tranexamic acid in artiifcial joint surgery

    Institute of Scientific and Technical Information of China (English)

    马金辉; 孙伟; 高福强; 王云亭; 李子荣

    2014-01-01

    Tranexamic acid ( TXA ) is economical and safe, with good hemostatic effects in joint surgery. The intravenous route is most commonly used. TXA can also be administrated orally or intra-articularly but not intrathecally or intra-cerebrally. Better hemostatic effects can be achieved both in spinal surgery and total hip arthroplasty ( THA ) with the use of TXA. TXA is generally injected intra-articularly in total knee arthroplasty ( TKA ) before the tourniquet was released and after the capsule was sutured. The patients who underwent TKA were divided into 2 groups, including one group receiving 1.5% TXA intra-articularly and the other group receiving 3.0% TXA intra-articularly. The postoperative blood loss volume was 1295 ml in the 1.5% TXA group, and 1208 ml in the 3.0% TXA group. Statistically signiifcant differences were observed between the 2 groups, and the patients receiving more TXA had less blood loss. Only the articular cavity is affected with the intra-articular administration of TXA. Such advantages as minimal systemic absorption, less intra-articular bleeding and reduced risk of deep venous thrombosis ( DVT ) and pulmonary embolism ( PE ) can be found with the intra-articular administration of TXA when compared with the intravenous administration. The intra-articular administration of TXA is superior to the intravenous administration. ( 1 ) Potential complications related to the intravenous administration of TXA can be avoided or decreased, particularly in high-risk patients, such as the patients with cardiovascular diseases, venous thromboembolism, renal dysfunction and so on. ( 2 ) The blood loss, blood transfusion and transfusion rate after TKA can be reduced with the intra-articular administration of TXA. TXA is contraindicated in the patients with a history of arterial or venous thrombosis, hematological system diseases, acute renal failure, seizures and/or hypersensitivity. Postoperative hemorrhage is caused by many factors, and the physicians

  19. 氨甲环酸对单侧全膝关节置换失血量的影响及安全性评价%Efficacy and safety of tranexamic acid on blood loss after unilateral total knee arthroplasty

    Institute of Scientific and Technical Information of China (English)

    闵鹏; 彭银虓; 胡江海; 顾祖超

    2015-01-01

    背景:全膝关节置换围手术期出血较多,而输血不仅额外增加费用,延长康复时间,也存在免疫反应和传染疾病的风险.因此,减少全膝关节置换失血量显得十分重要.目的:评估氨甲环酸在全膝关节置换中止血的有效性和安全性.方法:将 64 例因骨关节病拟行单侧全膝关节置换的患者随机分为两组,每组 32 例.氨甲环酸组于置换前 15 min将氨甲环酸按10 mg/kg稀释于250 mL等渗盐水中静脉滴注;对照组同时间点给予等量生理盐水.对比术中失血量、置换后可见失血量、置换后血红蛋白减少量、输血量、输血人数和置换后纤维蛋白原、凝血酶原时间等凝血评价指标.观察置换后下肢深静脉栓塞的症状,并在置换后30 d行下肢血管多普勒检查.结果与结论:两组术中出血量差异无显著性意义(P>0.05),氨甲环酸组置换后可见失血量低于对照组(P<0.001),氨甲环酸组的输血量和输血人数同样低于对照组(P<0.001);置换后血红蛋白值氨甲环酸组明显高于对照组(P<0.001).置换后3 h两组的凝血指标差异无显著性意义;但两组D-二聚体均明显高于置换前,氨甲环酸组低于对照组,差异有显著性意义(P<0.001).两组患者置换后均未发现下肢深静脉血栓形成.提示氨甲环酸能够有效减少全膝关节置换后的失血量、降低输血率和输血量,且不增加置换后深静脉血栓形成的风险.%BACKGROUND:Total knee arthroplasty is always associated with peripheral blood loss.Blood transfusion not only involves additional cost and prolongs rehabilitation time,but also carries substantial risk of immunologic reaction and disease transmission.Therefore it is very important to reduce blood loss of total knee arthroplasty.OBJECTIVE:To investigate the efficacy and safety of tranexamic acid on reducing blood loss after total knee arthroplasty.METHODS:We enroled 64 patients with primary osteoarthritis

  20. 氨甲环酸对全髋关节置换术隐性失血的影响%Effect of tranexamic acid on the hidden blood loss after total hip arthroplasty

    Institute of Scientific and Technical Information of China (English)

    傅峥; 张健; 姚海

    2012-01-01

    Objective: To assess the impact of tranexamic acid on the hidden blood loss after unilateral total hip arthroplasty. Methods: Totally 40 patients who received unilateral total hip arthroplasty due to femoral neck fracture were randomly divided into two groups. Group A included 20 cases without tranexamic acid,in which the patients were just given 250 ml normal saline when the surgery star-tod ; Group B included 20 cases with tranexamic acid, and the patients in this group were given 20 mg/kg tranexamic acid with 250 ml normal saline when the surgery started. The total red blood cell loss,visible red blood cell loss and hidden red blood cell loss of the two groups were measured and the comparative analysis was conducted. Results: Results of the visible red blood losses in group A and group B were (95.43 ±17.72)ml and (48.84 ± 15.04)ml,respectively; the hidden red blood loss in group A and group B were (322.37 ± 57.69) ml and (169. 89 ±58.50) ml,respectively. The visible and hidden red blood cell losses in group B were both significantly less than those in group A(P<0.05). Conclusion:Tranexamic acid reduces both the visible and hidden red blood loss after the unilateral total hip arthroplasty.%目的:探讨氨甲环酸对单侧全髋关节置换术隐性失血的影响.方法:40例因单侧股骨颈骨折行全髋关节置换术患者随机分为2组.A组20例,不使用氨甲环酸,手术开始时予250 ml生理盐水静滴;B组20例,使用氨甲环酸,手术开始时将氨甲环酸按20 mg/kg稀释于250 ml生理盐水中静滴.分别计算其显性及隐性红细胞丢失量,并进行相应对比分析.结果:A组与B组显性红细胞丢失量分别为(95.43 ±17.72) ml和(48.84±15.04) ml(P<0.05);A组与B组隐性红细胞丢失量分别为(322.37 ±57.69) ml和(169.89±58.50) ml(P<0.05).结论:氨甲环酸能明显减少单侧全髋关节置换术的显性及隐性失血.

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  3. Tranexamic Acid and Reduced Glutathione Clinical Observation of Treating Melasma%氨甲环酸联合还原型谷胱甘肽治疗黄褐斑的临床观察

    Institute of Scientific and Technical Information of China (English)

    陆海山; 郭剑; 陈智勇; 赵启明; 甘精兵; 周蓉蓉; 吴近芳

    2011-01-01

    [目的]观察氧甲环酸联合还原型谷胱甘肽治疗黄褐斑的临床疗效.[方法] 152例黄褐斑患者使用氧甲环酸联合还原型谷胱甘肽口服治疗.观察服药后的临床效果、疗效出现时间、不良反应等.[结果]治疗时间2~6个月,平均3.9个月.治疗后随访3个月,92.11%的患者色斑减轻;服药6个月后痊愈者13.16%、无效者7.89%;停药后色素重新加深及复发者12例,出现胃肠道反应5例,出现月经量减少4例,出现口腔溃疡1例,其余未发现其他明显的不良反应.[结论]氨甲环酸联合还原型谷胱甘肽治疗黄褐斑有较好效果,值得临床应用借鉴.%[Objective] Observation of tranexamic acid and reduced glutathione treatment of melasma the clinical efficacy. [Methods] One hundredand fifty-two patients with melasma were treated with oral administrationof tranexamic acid and reduced glutathione. A retrospective study was madeon the therapeutic effect and Side effects. [Results] The treatment period was 2-6 months (mean 3.9 months). The patients were followed for 3 monthsafter treatment. The total improvement rate was 92.11%. After 6 months'treatment , the percentages of patients who were curetl.or Invalided were13.16% and 7.89% respectively. 12 patients had recurrences. There were no obvious side effects of the treatment except 5 cases of gastrointestinalreaction,4 cases of reduced menstrual, 1 case of oral ulcers . [Conclusion] Tranexamic acid and reduced glutathione treatment of nw-lasma has goodeffect, worthy of clinical application and reference.

  4. 氨甲环酸局部压迫法治疗牙龈出血的临床评价%A Clinical Evaluation of Topical Application of Tranexamic Acid for the Treatment of Gingival Bleeding

    Institute of Scientific and Technical Information of China (English)

    于鑫; 杜小沛; 张婷婷; 朱文彦

    2016-01-01

    Objective To evaluate the clinical effection of topical application of tranexamic acid used to treat with gingival bleeding in the cavity filling. Methods 115 patients with gingival bleeding after the cavity preparation were randomly divided into the experimental group and the control group. Tranexamic acid and 3% hydrogen peroxide were respectively used to stop the bleeding in two groups. Hemostasis effectiveness and hemostasis time were recorded. Results The hemostasis time in the experimental group was significantly shorter than that in the control group (P<0.05). There was no significant difference between two groups in the hemostatic efficiency. Conclusion Topical application of tranexamic acid is an effective treatment for gingival bleeding in the cavity filling. It can significantly shorten the hemostasis time compared with hydrogen peroxide. It is worthy of popularization and application.%目的:评价氨甲环酸局部压迫法治疗窝洞充填术中牙龈出血的临床效果。方法将窝洞预备后出现牙龈出血的115例患者随机分为试验组和对照组,分别采用氨甲环酸和3%过氧化氢进行局部压迫止血,分别记录止血有效性和止血时间。结果试验组止血时间较对照组显著缩短(P <0.05),两组止血有效率的差别无统计学意义(P >0.05)。结论氨甲环酸局部压迫法可有效治疗窝洞充填术中牙龈出血,较过氧化氢可明显缩短止血时间,值得推广应用。

  5. Influence by different tranexamic acid administration time on intraoperative and postoperative bleeding volume of total hip arthroplasty%氨甲环酸不同给药时间对全髋关节置换术中及术后失血量的影响

    Institute of Scientific and Technical Information of China (English)

    许小志; 谢学文

    2016-01-01

    目的:探讨氨甲环酸不同给药时间对全髋关节置换(THA)术中及术后失血量的影响。方法300例行THA患者,随机分为A、B、C三组,各100例。A组不给予氨甲环酸, B组手术前10 min给予氨甲环酸1 g, C 组手术结束前10 min给予氨甲环酸1 g, B、C两组均术后6 h再次给予氨甲环酸1 g。记录三组的术中、术后失血量及深静脉血栓形成(DVT)发生情况。结果 B组术中、术后失血量均少于A、C组(P0.05)。结论氨甲环酸可有效减少THA术中、术后失血量,且手术前10 min、术后6 h使用止血效果更佳。%ObjectiveTo investigate influence by different tranexamic acid administration time on intraoperative and postoperative bleeding volume of total hip arthroplasty (THA).MethodsA total of 300 THA patients were randomly divided into groups A, B and C, with 100 cases in each group. Group A received no tranexamic acid, group B received 1 g tranexamic acid in preoperative 10 min, and group C received 1 g tranexamic acid at 10 min before operation ending. Both groups B and C received additional 1 g tranexamic acid in postoperative 6 h. Records were made on intraoperative and postoperative bleeding volume and occurred deep venous thrombosis (DVT) in three groups.ResultsGroup B had all less intraoperative and postoperative bleeding volume than groups A and C (P0.05). ConclusionTranexamic acid can effective reduce intraoperative and postoperative bleeding volume in THA, and its administration in preoperative 10 min and postoperative 6 h provides precisely hemostatic effect.

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    ... this page please turn Javascript on. Participating in Clinical Trials About Clinical Trials A Research Study With Human Subjects A clinical ... to treat or cure a disease. Phases of Clinical Trials Clinical trials of drugs are usually described based ...

  8. 氨甲环酸对Stanford A型主动脉夹层术患者的血液保护作用%Blood-saving effect of tranexamic acid in patients undergoing Stanford type A aortic dissection surgery

    Institute of Scientific and Technical Information of China (English)

    徐红党; 周俊辉; 韩宇; 刘旭平; 王平凡; 高传玉

    2015-01-01

    Objective To investigate the blood-saving effect of tranexamic acid in patients undergoing Stanford type A aortic dissection surgery.Methods Fifty-six patients of both sexes with acute Stanford type A aortic dissection, aged 34-58 yr, weighing 62-84 kg, of American Society of Anesthesiologists physical status Ⅱ or Ⅲ , with their left ventricular ejection fraction > 40%, undergoing emergency surgery, were randomly divided into 2 groups: control group (group C, n=26) and tranexamic acid group (group TA, n=30).Tranexamic acid was infused as a bolus of 10 mg/kg over 30 min before skin incision followed by an infusion of 10 mg · kg-1 · h-1 throughout the surgery in group TA.The equal volume of normal saline was given instead in group C.The total volume of drainage at 24 h after operation, the postoperative requirement of allogeneic red blood cells, fresh frozen plasma and platelets, and re-thoracotomy for bleeding were recorded.The postoperative mechanical ventilation time, duration of intensive care unit stay, and complications after operation were also recorded.Results Compared with group C, the total volume of drainage at 24 h after operation, and the requirement of allogeneic red blood cells, fresh frozen plasma and platelets were significantly reduced, the incidence of rethoracotomy for bleeding was decreased, the postoperative mechanical ventilation time, and duration of intensive care unit stay were shortened, and the incidence of postoperative acute lung injury and transient neurological dysfunction were decreased in group TA.Conclusion Tranexamic acid has blood-saving effect and can reduce postoperative bleeding and allogeneic blood transfusion in patients undergoing Stanford type A aortic dissection surgery.%目的 探讨氨甲环酸对Stanford A型主动脉夹层术患者的血液保护作用.方法 急诊行Stanford A型主动脉夹层术患者56例,性别不限,年龄34~58岁,体重62~84 kg,ASA分级Ⅱ或Ⅲ级,左室射血分数>40%.采

  9. 氨甲环酸对玫瑰痤疮患者皮肤屏障功能和炎症反应的影响%The influence of tranexamic acid on skin barrier function and inflammation in rosacea

    Institute of Scientific and Technical Information of China (English)

    孙楠; 牛悦青; 陈璨; 仲少敏; 刘慧贤; 吴艳

    2013-01-01

    Objectives: To examine the influence of tranexamic acid on rosacea lesions and skin barrier function. Methods: Thirty patients with rosacea were included in the split-face study. 3% tranexamic acid solution was applied on one half of the face and matrix solution on the other side. After 2 weeks, the severity of erythema and number of inflammatory lesions were assessed. Skin barrier related indexes (water content in the stratum corneum, pH value and TEWL) were measured by non-invasive skin physiological test, and the integrity of the stratum corneum, serine protease activity and amount of LL-37 were tested. Results: Compare to the control side, the severity of erythema and the number of the inflammatory lesions of the test side reduced significantly (P < 0.05); skin barrier related indexes, the integrity of the stratum corneum and the result of the lactic test improved obviously (P<0.05); tranexamic acid can also inhibit the stratum corneum serine protease activity (P < 0.05) and the expression of LL-37. Conclusions: Tranexamic acid can inhibit serine protease activity and reduce the processing of LL-37 in stratum corneum, it can also improve the damaged skin barrier function in patients with rosacea. Clinically, it can also inhibit the inflammation. It may serve as an adjuvant therapy in rosacea.%目的:研究氨甲环酸对玫瑰痤疮患者皮肤屏障功能及炎症反应的影响.方法:对30例玫瑰痤疮患者采用自身左右脸对照的方法,治疗侧外用3%氨甲环酸溶液,对照侧外用基质溶液,每天2次.2周后评价双侧红斑程度、炎症性皮损数量及屏障相关生理指标[角质层含水量、经皮水分丢失(TEWL)、pH值],并检测角质层完整性、角质层丝氨酸蛋白酶活性以及LL-37表达.结果:治疗侧较对照侧红斑程度轻,炎症性皮损数量显著减少(P < 0.05);皮肤屏障相关生理指标、角质层完整性及乳酸刺激试验结果有显著改善,差异有统计学意义(P < 0.05);氨甲

  10. Efficacy of Ruby Dot Matrix Laser Combined with Tranexamic Acid Tablets in the Treatment of Melasma%红宝石点阵激光联合氨甲环酸治疗黄褐斑临床观察

    Institute of Scientific and Technical Information of China (English)

    张璃; 林孝华; 唐东阳

    2012-01-01

    Objective To observe the clinical therapeutic efficacy of ruby dot matrix laser combined with tranexamic acid tablets in the treatment of melasma. Methods Laser treatment; choice dot matrix pattern, with energy density from 2. 5mJ/mm to 3. 5mJ/mm . Everyone accepted treatment twice one month. One course included 4 times of treatment. Everyone accepted only one course treatment. Tranexamic acid tablets treatment; Everyone was given tranexamic acid tablets 500mg per day, 2 months as 1 course. Everyone accepted 3 courses treatment. The severity and the area of melasma was assessed by two dermatologists using the melasma area severity index ( MASI). At regular in tervals the degree of improvement in pigmentation was reassessed with MASI scores. Effect appearance, recurrence, side-effects were also recorded. Results The 120 patients were followed for 6 ~ 12 months after treatment. 118 patients(98. 33% ) appeared the varying degree facial pigmentation loss. 5 cases(4. 17% ) was cured thoroughly, 74 cases(61.67% ) were cured better than before obviously. And in 39 cases treated for effective. The efficiency was 65. 84%. 37 patients (30. 83% ) showed clinical effect at the half-month treatment, 52 patients (43. 33%) showed clinical effect after one month treatment. Furthermore, only 8 patients(6. 67% ) had recurrences. There were no obvious side-effects of the treatment except a hypomenorrhea in 7 patients. Conclusion Ruby dot matrix laser combined with tranexamic acid tablets is a novel therapy, which is safe and effective in the treatment of melasma.%目的 对红宝石点阵激光联合氨甲环酸片治疗黄褐斑进行临床疗效观察.方法 激光治疗:采用点阵模式,能量密度2.5 ~ 3.5J/cm2,每隔2周治疗1次,2个月为1个疗程;同时口服氨甲环酸片500mg,1次/d,2个月为1个疗程,连续治疗3个疗程;对患者进行黄褐斑皮损面积和严重程度指数(MASI)评分,采用自身治疗前/后对照法进行疗效观察,记录起效

  11. 氨甲环酸对老年全髋关节置换术患者的血液保护效果%Blood-saving effect of tranexamic acid in elderly patients undergoing total hip replacement

    Institute of Scientific and Technical Information of China (English)

    潘宁; 熊鹰; 熊君宇

    2012-01-01

    目的 评价氨甲环酸对老年全髋关节置换术患者的血液保护效果.方法 择期全髋关节置换术患者160例,性别不限,年龄65-70岁,体重指数16-22 kg/m2,ASA分级Ⅱ或Ⅲ级,采用随机数字表法,将其分为2组(n=80):对照组(C组)和氨甲环酸组(T组).切皮前T组经15 m in静脉输注氨甲环酸15 mg/kg,C组给予等容量生理盐水.术中监测Hb、PIt、PT和APTT指导输血.记录术中出血量、术后12 h和48 h出血量,术中、术后异体血输注情况.记录术后并发症的发生情况.结果 两组术中出血量比较差异无统计学意义(P>0.05).与C组比较,T组术后出血量、异体红细胞使用率降低(p<0.05),两组末见术后并发症的发生.结论 氨甲环酸对老年全髋关节置换术患者具有一定血液保护效应,但是临床价值有限.%Objective To evaluate the blood-saving effect of tranexamic acid in elderly patients undergoing total hip replacement.Methods One hundred and sixty ASA Ⅱ or Ⅲ patientss of both sexes,aged 65-70 yr,with a body mass index of 16-22kg/m2,undergoing total hip replacement,were randomly divided into 2 groups(n =80,each):control group(group C)and tranexamic acid group(group T).Anesthesia was induced with midazolam,fentanyl,etomidate and atracurium.The patients were tracheal intubated and mechanically ventilated.PEr CO2 was maintained at 35-45 mm Hg.Aneslhesia was maintained with propofol,remifentanil and atracurium.Before the skin incision,tranexamic acid 15 mg/kg was infused over 15 m in in group T,while the equal volume of normal saline was given instead in group C.Hemoglobin(Hb),platelet count(PLT),prothrombin time(PT),and activated partial thromboplastin time(APTT)were monitored during operation to guide blood transfusion.Intraoperative and postoperative blood loss and allogeneic blood transfusion were recorded.Postoperative complications were also recorded.Results There was no significant difference in the amount of intraoperative

  12. 静脉滴注联合关节腔内使用氨甲环酸对初次全膝关节置换术后隐性失血的效果%The effect on intravenous and intra-articular cavity injection of tranexamic acid on recessive loss of blood in primary total knee arthroplasty

    Institute of Scientific and Technical Information of China (English)

    侯颖周; 王少华; 魏瑄; 宋树春; 王爱国

    2016-01-01

    目的 探讨氨甲环酸在减少膝关节置换术后隐性失血的效果.方法 将100例人工全膝关节置换(TKR)患者随机平均分为2组:氨甲环酸组和对照组.切皮前15 min均使用氨甲环酸0.5g静脉滴注,术后氨甲环酸组在松止血带前给予氨甲环酸0.5g静脉滴注,同时在关闭切口后由引流管逆行灌入2%氨甲环酸25 ml,而对照组予以等量生理盐水静脉滴注和灌入.术后2d分别计算总失血量、术中失血量、术后引流量、隐性失血量和输血率.结果 氨甲环酸组的总失血量、置换术后引流量、隐性失血量、输血率分别为(0.326±0.221)L、(0.048±0.018)L、(0.210±0.113)L、(0.231±0.176)L、19%,低于对照组的(1.012±0.520)L、(0.056±0.012)L、(0.402±0.231)L、(0.532±0.514)L、65%,差异均有统计学意义(P<0.05).结论 氨甲环酸在减少膝关节置换术后隐性失血方面效果显著.%Objective The effection of tranexamic acid in recessive loss of blood in primary total knee arthroplasty.Methods One hundred patients having primary total knee arthroplasty were randomly divided into 2 groups,the tranexamic acid group and the control group,with 50 patients in each.the groups,0.5 g tranexamic acid was infused intravenously within 15 minutes befor skin incision,before deflation of the tourniquet,the tranexamic acid group accepted 0.5 g tranexamic acid and 25 ml intra-articular cavity injection of tranexamic acid intravenously,while an equal volume of normal saline was given instead in the control group.After 2 days,respectively calculate the total amount of blood loss,intraoperative blood loss,postoperative drainage,hidden blood loss and transfusion rates.Results The total amount of blood loss tranexamic acid group and the control group,after the replacement of drainage,hidden blood loss and transfusion rate in the ranexamic acid group were (0.326 ±0.221) L,(0.048 ±0.018) L,(0.210 ±0.113) L,(0.231 ±0.176) L,19%,lower than the control

  13. Relationship of tranexamic acid therapy duration with hidden blood loss after total hip arthroplasty%氨甲环酸使用时间与全髋关节置换术隐性失血的临床研究

    Institute of Scientific and Technical Information of China (English)

    傅峥; 张健

    2013-01-01

    Objective To assess the impact of tranexamic acid on visible and hidden blood loss after the preliminary unilateral total hip arthtoplasty (THA).Methods The study involved 60 patients who received primary unilateral THA due to femoral neck fracture from March 2010 to September 2011.They were 18 males and 42 females,at 58 to 86 years of age (average 74.5 years).They were divided into Group A (n =20),not given tranexamic acid,Group B (n =20),given tranexamic acid in operation,Group C (n =20),given tranexamic acid at preoperative one hour according to stratified random method.Total red blood cell loss,visible red blood cell loss,and hidden red blood cell loss in each group were calculated.Results Visible red blood cell loss in Groups A,B,and C was (95.4 ± 17.7) ml,(45.5 ± 11.5) rnl,and (45.3 ± 8.4) ml respectively.Moreover,difference of visible red blood cell loss was significant between Groups A and B (P < 0.05),but insignificant between Groups B and C (P > 0.05).Hidden red blood cell loss in Groups A,B,and C was (322.4 ± 57.7) ml,(203.8 ±46.6) ml,and (137.6 ± 34.7) ml respectively,with significant difference between Groups A and B (P<0.05) and between Groups B and C (P<0.05).Conclusions Tranexamic acid reduces the visible and hidden blood loss in primary unilateral THA significantly.While tranexamic acid administered at preoperative one hour gains advantage of less hidden blood loss over the intraoperative administration.%目的 探讨氨甲环酸对初次单侧全髋关节置换术(total hip arthroplasty,THA)显性及隐性失血的影响. 方法 选取2010年3月-2011年9月行初次单侧THA患者60例,其中男18例,女42例;年龄58 ~86岁,平均74.5岁,诊断均为股骨颈骨折.按分层随机分组法分为:A组(20例,不使用氨甲环酸)、B组(20例,术中使用氨甲环酸)和C组(20例,术前1h使用氨甲环酸).计算总红细胞丢失量、显性红细胞丢失量及隐性红细胞丢失量. 结果 A、B、C组显性

  14. Effects of different dose tranexamic acid in fibrinolysis during liver transplantation%不同剂量氨甲环酸对肝移植术中纤溶功能的影响

    Institute of Scientific and Technical Information of China (English)

    陈祯; 李坤河; 郭隽英; 肖亮灿; 白雪

    2015-01-01

    Objective To investigate the effects of different dose of tranexamic acid in fibrinolysis during liver transplantation. Methods Sixty ASA Ⅱ~ Ⅳ liver transplant recipients, were randomly, double-blind assigned to one of 3 groups (n = 20): group control (group C), group tranexamic acid 1 (group T1) and group tranexamic acid 2 (group T2). The patients in group C received a loading dose of normal saline 10 mL, then continued infuse normal saline at 20 mL/h until neohepatic phase 120 min, while in other two groups, patients received a loading dose of tranexamic acid 1 g, totally 10 mL, followed by continuous infusion at 10 mg/(kg·h) in group T1 or 20 mg/(kg·h) in group T2 until neohepatic phase 120 min. Prothrombin time, fibrinogen, fibrin degradation product and D-dimers were measured before operation (T0), 120 min after the skin incision (T1), nonhepatic phase 30 min (T2), neohepatic phase 120 min (T3). Blood loss, fresh frozen plasma dosage, fibrinogen dosage and thromboembolic events were recorded. Results The plasma concentration of fibrin degradation product and plasma concentration of D-dimers were different in the 3 groups, group T2 0.05). Conclusions Continuous infusion of tranexamic acid can inhibit fibrinolysis during liver transplantation. No adverse event of thrombosis was detected. Larger dose of tranexamic acid can reduce blood loss and fresh frozen plasma transfusion.%目的:观察肝移植手术中采用不同剂量的氨甲环酸(TXA)对患者纤溶功能的影响。方法:60例拟行肝移植的患者随机、双盲分为3组(n =20),对照组(C组)、TXA1组(T1组)、TXA2组(T2组)。 C组:手术前经静脉给予10 mL生理盐水,随后20 mL/h泵注至新肝期120 min;T1组和T2组则给予1 g TXA共10 mL,随后T1组为10 mg/(kg·h),T2组为20 mg/(kg·h)泵注至新肝期120 min。于手术前(T0)、手术120 min (T1)、无肝期30 min(T2)、新肝期60 min(T3)测凝血酶原

  15. A randomized prospective analysis of alteration of hemostatic function in patients receiving tranexamic acid and hydroxyethyl starch (130/0.4 undergoing off pump coronary artery bypass surgery

    Directory of Open Access Journals (Sweden)

    Murali Chakravarthy

    2012-01-01

    Full Text Available Postoperative hemorrhagic complications is still one of the major problems in cardiac surgeries. It may be caused by surgical issues, coagulopathy caused by the side effects of the intravenous fluids administered to produce plasma volume expansion such as hydroxyl ethyl starch (HES. In order to thwart this hemorrhagic issue, few agents are available. Fibrinolytic inhibitors like tranexamic acid (TA may be effective modes to promote blood conservation; but the possible complications of thrombosis of coronary artery graft, precludes their generous use in coronary artery bypass graft surgery. The issue is a balance between agents that promote coagulation and those which oppose it. Therefore, in this study we have assessed the effects of concomitant use of HES and TA. Thromboelastogram (TEG was used to assess the effect of the combination of HES and TA. With ethical committee approval and patient′s consent, 100 consecutive patients were recruited for the study. Surgical and anesthetic techniques were standardized. Patients fulfilling our inclusion criteria were randomly allocated into 4 groups of 25 each. The patients in group A received 20 ml/kg of HES (130/0.4, 10 mg/kg of T.A over 30 minutes followed by infusion of 1 mg/kg/hr over the next 12 hrs. The patients in group B received Ringer′s lactate + TA at same dose. The patients in the Group C received 20 ml/kg of HES. Group D patients received RL. Fluid therapy was goal directed. Total blood loss was assessed. Reaction time (r, α angle, maximum amplitude (MA values of TEG were assessed at baseline, 12, 36 hrs. The possible perioperative myocardial infraction (MI was assessed by electrocardiogram (ECG and troponin T values at the baseline, postoperative day 1. Duration on ventilator, length of stay (LOS in the intensive care unit (ICU were also assessed. The demographical profile was similar among the groups. Use of HES increased blood loss significantly (P < 0.05. Concomitant use of TA

  16. How Do Clinical Trials Work?

    Science.gov (United States)

    ... Trials Clinical Trial Websites How Do Clinical Trials Work? If you take part in a clinical trial, ... kol). This plan explains how the trial will work. The trial is led by a principal investigator ( ...

  17. Preparation and Ultrasound Imaging of Tranexamic Acid Microbubble-liposome Compound%氨甲环酸脂质体微泡复合物的制备及体外超声显影的初步研究

    Institute of Scientific and Technical Information of China (English)

    李婷; 严飞; 靳巧锋; 许瑞雪; 郑海荣; 李叶阔

    2013-01-01

    Purpose To prepare the tranexamic acid liposome with high encapsulation efficiency and stability, through interaction of avidin and biotin, and to prepare its microbubble-liposome compound whose properties are to be assessed. Materials and Methods Thin film hydration technology was used to prepare tranexamic acid liposome. Taking encapsulation efficiency as indication, the microbubble-liposome compound was optimized by the design of orthogonal experiment. The basic properties of the compound were tested and the acoustic characteristic was measured by ultrasound and gray-scale values. Results The optimum formula of tranexamic acid liposome were as follows:molar ratio of 1,2-dipalmitoyl-sn-glycero-3-phosphocholine, cholesterol and 1,2-distearoyl-sn-glycero-3-phosphoethanolamine-N-[biotinyl (polyethylene glycol) 2000] was 85∶10∶5;concentration of tranexamic acid was 5.0%;ultrasonic time was 15 min. The encapsulation efficiency was 62.62%. The size was approximately (104.00±1.84) nm. The Zeta potential was approximately (-50.50±0.56) mV. The liposome was good in stability. The size of the microbubble-liposome compound was approximately (4.56±0.28)μm. Under the microscope, they were round with transparent center, evenly distributed without aggregation. The acoustic characteristic of the compound in vitro showed typical characteristics of microbubble, which was compatible with the results under the microscope. As the concentrations of the compound increased, both ultrasound imaging effect and the gray-scale values enhanced. However, to avoid acoustic shadows, the imaging concentrations were supposed to be at least lower than 1.15×108/ml in vitro. Conclusion The preparation of the tranexamic acid microbubble-liposome compound can be optimized by taking encapsulation efficiency as reference, and it can be effectively traced by ultrasound according to its acoustic characteristics in vitro.%目的制备包封率高、稳定性好的氨甲环酸脂质体,并与微

  18. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... Participating in Clinical Trials: About Clinical Trials In This Topic About Clinical Trials Risks and Benefits Terms ... with Your Doctor Taking Medicines The information in this topic was provided by the National Library of ...

  19. Participating in Clinical Trials

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    Full Text Available ... Participating in Clinical Trials About Clinical Trials A Research Study With Human Subjects A clinical trial is a research study that involves human subjects. The purpose of ...

  20. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... that could identify a disease in its early stages. Usually, trial participants must show signs of the ... Trials Clinical trials of drugs are usually described based on their phase. The U.S. Food and Drug ...

  1. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... trial is to find out if an experimental drug, therapy, medical device, lifestyle change, or test will ... disease. Phases of Clinical Trials Clinical trials of drugs are usually described based on their phase. The ...

  2. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... on. Participating in Clinical Trials About Clinical Trials A Research Study With Human Subjects A clinical trial is a research study that involves human subjects. The purpose ...

  3. 静脉输注氨甲环酸对全膝关节置换后隐性失血的影响%Effect of intravenous tranexamic acid on hidden blood loss in total knee arthroplasty

    Institute of Scientific and Technical Information of China (English)

    赵旻暐; 李子剑; 张克; 曾琳; 方拓

    2015-01-01

    背景:人工全膝关节置换过程中,止血带的使用、手术创伤等因素会导致纤溶系统的异常激活,是术后失血的主要原因。氨甲环酸是一类抗纤溶药物,在人工全膝关节置换中使用,可减少置换后显性失血、总失血量,并降低异体血输血率。然而,氨甲环酸对人工全膝关节置换后隐性失血的影响尚未明确。目的:观察静脉输注氨甲环酸对初次全膝关节置换后隐性失血的影响。方法:回顾性分析2013年6至12月北京大学第三医院行初次单侧全膝关节置换54例患者的临床资料,按照是否使用氨甲环酸分为两组。氨甲环酸组22例在术中经静脉给予总量2 g的氨甲环酸,对照组32例使用等量生理盐水。两组患者置换后均口服利伐沙班抗凝。记录患者置换前及置换后连续5 d的血红蛋白、血红细胞压积,采用Gross方程计算总失血量和隐性失血量,比较两组间失血量的差异性。置换后1周行下肢静脉超声检查,判断有无下肢深静脉血栓形成。结果与结论:两组患者一般资料、围术期情况等比较差异均无显著性意义(P >0.05)。氨甲环酸组患者置换后引流量、显性失血量、总失血量、自体血回输量、异体血输注量均明显少于对照组,差异有显著性意义(P 0.05). Postoperative drainage, dominant blood loss, total blood volume, the amount of autologous blood transfusion and the amount of alogeneic blood transfusion were significantly less in the tranexamic acid group than in the control group (P < 0.05). According to Gross formula, the difference of hidden blood loss was statisticaly significant between the tranexamic acid group (302.9±189.9) mL and the control group (596.8±271.4) mL (P < 0.05). Deep vein thrombosis appeared in one case between the two groups after replacement. Results indicate that intravenous infusion of tranexamic acid dramaticaly decreased the hidden blood

  4. Tranexamic Acid Reduce Blood Loss in Complex Posterior Lumbar Surgery%氨甲环酸对减少复杂腰椎后路手术围手术期出血的临床疗效

    Institute of Scientific and Technical Information of China (English)

    石厚银; 江锋; 谢显平; 马川; 胡旭光

    2016-01-01

    Objective To evaluate the efficacy of tranexamic acid on blood loss associated with complex posterior lumbar surgery. Methods 238 patients who received complex posterior lumbar surgery,from June 2013 to December 2015,were retrospectively analyzed. 123 patients were received tranexamic acid before incision in treatment group. 115 patients were not received tranexamic acid during perioperative period in the control group. Intraoperative estimated blood loss,postoperative drainage volume,amount of blood transfusion,hemoglobin and complications were compared. Results The average intraoperative estimated blood loss was significant difference between the groups[TXA group(523±153)ml vs. control group(785±188) ml,P=0.026]. The average postoperative drainage volume was significant difference too,between the groups[TXA group(265±84)ml vs. control group(381±105)ml,P=0.031]. The amount of blood transfusion was no statistical different between groups[TXA group(278±53)ml vs. control group(335±71)ml,P=0.187]. There was insignificantly different in operative time. Deep vein thrombosis and other adverse effects did not discover in both groups. Conclusion Tranexmaic acid is safe and effective in complex posterior lumbar surgery.%目的:观察氨甲环酸减少复杂腰椎后路手术围手术期出血的疗效与安全性。方法回顾2013年6月~2015年12月238例行复杂腰椎后路手术患者,其中氨甲环酸组123例,对照组115例。比较氨甲环酸组与对照组术中出血量,术后引流量,输血量,血红蛋白及深静脉血栓等。结果术中出血量:氨甲环酸组(523±153)ml,对照组(785±188)ml,差异有统计学意义(P=0.026);术后引流量:氨甲环酸组(265±84) ml,对照组(381±105)ml,差异有统计学意义(P=0.031);输血量:氨甲环酸组(278±53)ml,对照组(335±71)ml,差异无统计学意义(P=0.187);两组均未见深静脉血栓、肾功能

  5. 离子色谱法测定氨甲环酸注射液中依地酸二钠的含量%IC determination of disodium edetate in tranexamic acid injection

    Institute of Scientific and Technical Information of China (English)

    李恒; 晏菊姣; 黄京芳

    2012-01-01

    Objective: To establish an ion chromatography (IC) method for the determination of disodium edetate in tranexamic acid injection. Methods; The determination was performed on an Ionpac AS14A column (4 mm × 250 mm) with an Ionpac AG14A guard column(4 mm × 50 mm) using a mixture of sodium carbonate 5 mmol · L-1 and sodium bicarbonate 1 mmol · L-1 as the mobile phase at a flow rate of 1. 0 mL · min-1. A conductivity detector and an ASRS suppressor were used as ASRS - ULTRA(4 mm) was set at an automatic restrain circulation pattern,with inhibit current of 50 mA, conductivity detection pool at 35 ℃ , sample quantity of 25 μL. The content of disodium edetate in tranexamic acid injection was detected directly by the standard working curve of disodium edetate. Results ; The standard curve was linear over the range of 5. 226 - 209. 0μg · mL-1 (r = 0. 9981). The average recovery (n =3) was 97. 4% - 100. 1% . Conclusion; The method is simple,accurate,and suitable for the determination of disodium edetate in tranexamic acid injection.%目的:建立氨甲环酸注射液中依地酸二钠的含量测定方法.方法:采用离子色谱法测定.使用Ionpac AS14A阴离子分离柱,Ionpac AG14A保护柱,淋洗液为含5mmol·L-1碳酸钠、1 mmol·L-1碳酸氢钠的混合溶液,流速为1.0 mL·min-1,ASRS -ULTRA 4 mm自动抑制循环模式,抑制电流为50 mA,电导检测池温度为35℃,进样量为25 μL.由依地酸二钠标准工作曲线直接测得氨甲环酸注射液中依地酸二钠含量.结果:依地酸二钠浓度在5.226 ~209.0 μg· mL-1范围内呈良好的线性关系(r=0.9981);平均回收率(n=3)为97.4%~100.1%.结论:本方法简单、快速,可以用于氨甲环酸注射液中依地酸二钠含量的测定.

  6. 氨甲环酸在心肺转流下心内直视手术麻醉中的应用%Clinical efficiency of tranexamic acid in cardiac patients undergoing cardiopulmonary bypass

    Institute of Scientific and Technical Information of China (English)

    肖敬波; 汪卫兵; 周新; 王胜斌; 方才

    2011-01-01

    Aim To evaluate the efficiency and security of tranexamic acid in cardiac patients undergoing cardiopulmonary bypass. Meth ods 60 patients, scheduled for cardiopulmonary bypass were randomly divided into two groups with 30 patients in each group. In tranex amic acid group( group A ),patients received tranexamic acid( total dosage 90 mg · kg -1 ), one half of total dosage was injected after in duction of anesthesia,the remaining dosage was injected at a rate of 1.0 mg · kg -1 · h -1 via microinfusion pump during intraoperation. In placebo group( group B ), patients acted as group A injected normal saline( total dosage 9 ml · kg -1 ). The haematocrit( Hct) ,platelet counts( Plt )and level of creatinine both prime and postoperation in two groups were recorded. The postoperative mediastinal chest tube drainage during 24 hours, blood product transfusions were all recorded, and the allergic reactions for all patients were observed. Results The postoperative mediastinal chest tube drainage during 24 hours and blood product transfusions were significantly more in group B than in group A( P < 0.05 ), and no adverse effects such as allergic reactions, renal dysfunction were observed in two groups. Conclusion The tranexamic acid was effective to reduce postoperative bleeding and blood product transfusions in cardiac patients undergoing cardiop ulmonary bypass.%目的 观察和评估在心肺转流手术中应用抗纤溶药氨甲环酸的疗效和安全性.方法 60例拟行心肺转流手术患者,随机分为氨甲环酸组(A组,n=30)和对照组(B组,n=30),其中A组按总量90 mg·kg-1分两次给予氨甲环酸,诱导后切皮前静注1/2量,另1/2量术中持续泵注1.0 mg·kg-1·h-1.B组给予0.9%氯化钠液9 ml·kg-1.记录两组手术前后血细胞压积(Hct)、血小板计数(Plt)、肌酐、术毕及术后24 h心包纵隔引流量和输血量,并观察过敏反应.结果 与B组比较,A组术后24 h心包纵隔引流量和输血量显著降低(P<0.05),无

  7. 卡络磺钠和氨甲环酸治疗肺结核咯血的疗效%Carbazochrome Sodium Sulfonate and Tranexamic Acid for the Treatment of Pulmonary Tuberculosis Hemoptysis

    Institute of Scientific and Technical Information of China (English)

    杜冉

    2013-01-01

    Objective Observation of carbazochrome sodium sulfonate and tranexamic acid in the treatment of hemoptysis of pulmonary tuberculosis the clinical ef ect. Methods In 2010 January~2012 June treated 60 cases of patients with pulmonary tuberculosis hemoptysis as the research object, divide them into two groups, Group A (n=30) patients using carbazochrome sodium sulfonate treatment, B group (n=30) using tranexamic acid treatment, comparative analysis of two groups of patients with clinical ef ects and adverse reactions. Results A group (5.6±3) bleeding time is slightly shorter than the H B group (6±3.3) bleeding time of H, but the two groups of hemostatic time dif erence was not significant, the difference was not statisticaly significant (P>0.05);after treatment, A group total effective rate was 93.5%, total effective rate was 90% in group B the two group, no significant difference, the dif erence was not statisticaly significant (P>0.05); A group did not show any adverse reaction in 7 cases in group B, the occurrence of adverse reactions, between the two groups was significant, with statistical significance (P<0.05). Conclusion For mild hemoptysis of pulmonary tuberculosis, recommended the use of carbazochrome sodium sulfonate treatment, for the more serious hemoptysis of pulmonary tuberculosis, suggested that the preferred tranexamic acid treatment.%  目的观察卡络磺钠和氨甲环酸在治疗肺结核咯血方面的临床效果。方法将2010年1月~2012年6月期间收治的60例肺结核咯血患者为研究对象,将其随机分为两组,A组(n=30)患者采用卡络磺钠治疗,B组(n=30)采用氨甲环酸治疗,对比分析两组患者的临床效果以及不良反应。结果 A组的止血时间(5.6±3.0)h要略短于B组的止血时间(6.0±3.3)h,但两组止血时间差异不显著,不具有统计学意义(P>0.05);经过治疗后,A组总有效率为93.5%, B组总有效率为90.0%,两组差异不显著

  8. EFECTO DE DOS DOSIS BAJAS DE ÁCIDO TRANEXÁMICO EN EL SANGRADO POSTOPERATORIO DE CIRUGÍA CARDÍACA / Effect of two low doses of tranexamic acid in post-operative bleeding after cardiac surgery

    Directory of Open Access Journals (Sweden)

    Osvaldo González Alfonso

    2010-12-01

    Full Text Available Resumen Introducción y objetivos: En la cirugía cardiovascular puede ocurrir un sangrado excesivo, durante la intervención y después de esta. El objetivo de la investigación fue valorar los efectos de un protocolo de dosis bajas de ácido tranexámico en la prevención del sangrado postoperatorio cardiovascular. Método: Se realizó un estudio descriptivo, longitudinal, prospectivo, no aleatorizado, en el Cardiocentro de Santa Clara, con 51 pacientes operados con circulación extracorpórea, a los que se les administraron dos dosis de 1 gramo de ácido tranexámico; se evaluaron variables, como: tiempos de circulación extracorpórea, número de reintervenciones por fibrinolisis, cantidad de transfusiones administradas y cuantía de las pérdidas hemáticas en las primeras 24 horas de la intervención. Resultados: El sangrado postoperatorio promedió 1272,9 ± 1148,8 ml, el 52,9 % de los enfermos tuvieron pérdidas sanguíneas menores a 1000 ml en las primeras 24 horas de operados. El 58,8 % de los pacientes no requirió de transfusiones sanguíneas alogénicas, y solo se administraron a los enfermos transfundidos, un promedio de 1,7 ± 3,4 unidades de concentrado de glóbulos rojos. Solo dos pacientes requirieron ser reintervenidos por fibrinólisis exagerada. Conclusiones: Las dosis bajas de ácido tranexámico empleadas en el estudio demostraron ser útiles para reducir el sangramiento postoperatorio en la cirugía cardíaca, a la vez que mantienen bajo el número de transfusiones alogénicas. / Abstract Introduction and objectives: In cardiovascular surgery an excessive bleeding can occur, both during the surgical procedure and after it. The objective of this investigation was to assess the effects of a low dose protocol of tranexamic acid in the prevention of bleeding following cardiovascular surgery. Method: A descriptive, longitudinal, prospective and non-randomized study with 51 patients who underwent surgery with extracorporeal

  9. Q开关1064 nm激光联合氨甲环酸治疗黄褐斑临床观察%Combined Q-Switched Nd: YAG Laser and oral tranexamic acid for the treatment of melasma

    Institute of Scientific and Technical Information of China (English)

    邓永辉; 苑凯华; 李勤; 蔡金辉

    2013-01-01

    目的 探讨Q开关1064 nm激光联合氨甲环酸治疗黄褐斑的临床疗效和安全性.方法 100例黄褐斑患者随机分为两组,每组50例.A组接受Q开关1064 nm激光治疗,同时口服氨甲环酸;B组单纯接受Q开关1064 nm激光治疗.经过3个疗程治疗后观察疗效及不良反应.结果 A组基本治愈率46%,有效率74%;B组基本治愈率18%,有效率30.2%,两组疗效差异有统计学意义(P<0.05).口服氨甲环酸8个月未见严重不良反应.结论 口服氨甲环酸可提高Q开关1064 nm激光治疗黄褐斑的临床疗效,且不良反应小.%Objective To explore the clinical effect and safety of treating melasma with the combination of Q-Switched Nd:YAG Laser and oral tranexamic acid. Methods One hundred patients were randomly divided into group A and B. Group A was treated by Q-Switched Nd:YAG Laser combinated with oral tranexamic acid. Group B was only treated by Q-Switched Nd:YAG Laser. The clinical effect and side effects were observed after three courses of treatment. Results In group A, the basic cure rates was 46%, total effective rate was 74%. In group B, the basic cure rates was 18%, total effective rate was 30.2%. The results had significant difference between the two groups (P<0.05). Conclusion Combination therapy can promote the efficacy of melasma and without severe side-effects.

  10. Clinical trials of homoeopathy.

    OpenAIRE

    Kleijnen, J.; Knipschild, P; ter Riet, G

    1991-01-01

    OBJECTIVE--To establish whether there is evidence of the efficacy of homoeopathy from controlled trials in humans. DESIGN--Criteria based meta-analysis. Assessment of the methodological quality of 107 controlled trials in 96 published reports found after an extensive search. Trials were scored using a list of predefined criteria of good methodology, and the outcome of the trials was interpreted in relation to their quality. SETTING--Controlled trials published world wide. MAIN OUTCOME MEASURE...

  11. 关节腔注射氨甲环酸对全膝关节置换术后的影响%Effect of intra-articular injection of tranexamic acid after total knee arthroplasty

    Institute of Scientific and Technical Information of China (English)

    王绍钱; 郑曙翘

    2014-01-01

    Objective To explore the effect of articular cavity injection of tranexamic acid on blood loss ,function recovery and post-operative complication after total knee arthroplasty .Methods Forty-six patients who got total knee arthroplasty caused by osteoarthritis ( OA) from Jan 2012 to Aug 2013 were selected and randomly divided into group A with topical application of tranexamic acid (23 cases) and group B(23 cases).Patients in group A were all injected 2.0g tranexamic acid with 20ml normal saline into articular cavity after ending seam skin surgery,while those in group B were injected 20ml normal saline and closed drainage tube 2h.The postoperative blood loss ,number of blood transfusion and blood transfusion volume,post operative hemoglobin(Hb) and hematocrit(Hct),6W postoperative knee HSS score,lower ex-tremity deep vein thrombosis ( DVT) or pulmonary embolism were compared between the two groups .Results Intraoperative total postopera-tive blood loss ,the number of blood transfusion and blood transfusion volume ,postoperative hemoglobin and hematocrit between the two groups indicated statistical significance(P0.05).The postoperative knee HSS scores of the two groups indicated no statistical significance (P 0.05).DVT was not found in 46 cases of patients by lower limb vascular Doppler ultrasound examination after oper -ating 2w,and neither were lower limb DVT or pulmonary embolism found by flowing up visiting in 6w postoperative.Conclusion Articular cavity injection of tranexamic acid can obviously decrease the postoperative blood loss and transfusion rate ,and it also doesn't increase the risk of DVT occurrence at the end of total knee arthroplasty .%目的:探讨关节腔注射氨甲环酸( TXA)对全膝关节置换术( TKA)术后出血量、术后功能恢复及术后并发症的影响。方法因骨性关节炎( OA)行全膝关节置换术的患者46例,随机分为氨甲环酸组( A组,23例),对照组( B组,23例),A组于手

  12. Significant improvement in crow's feet after treatment with Jet-M and a mixed solution of copper-GHK, oligo-hyaluronic acid, rhodiolar extract, tranexamic acid, and β-glucan (GHR formulation).

    Science.gov (United States)

    Byun, Sang-Young; Chae, Je-Byeong; Na, Jung-Im; Park, Kyoung-Chan

    2016-10-01

    Jet-M (Tav-Tech Ltd., Israel) is an instrument for skin resurfacing. When it sprays microdroplets of solution or shoots air on the skin, exfoliation and stretching of superficial layers can occur. Thus, it will increase percutaneous absorption of vitamins and other cosmetic agents. A cosmetic preparation containing copper-glycyl-L-histidyl-L-lysine, oligo-hyaluronic acid, rhodiolar extract, tranexamic acid, and β-glucan was used with Jet-M in one patient. Anesthesia was not administered and there was no pain during the treatment. A male aged 59 years was treated once a week for 12 weeks. In the clinical photographs, wrinkles around the treated eye were greatly decreased. Skin biopsies were taken from treated and untreated areas. Hematoxylin and eosin and Masson's trichrome staining showed increased collagen production in the upper dermis. On the other hand, collagen IV production was slightly increased. Fibrillin-1 and procollagen type 1 were greatly increased and tropoelastin was also increased. There was no adverse effect during and after treatment. PMID:27064823

  13. 氨甲环酸外用对小鼠角质形成细胞分化脱落相关蛋白表达水平的影响%Effect of Topical Tranexamic Acid on Expression of Proteins Involved in Differentiation and Desquamation of keratinocyte

    Institute of Scientific and Technical Information of China (English)

    路雪艳; 门月华; 李云珠; 刘静; 赵暕; 姜薇

    2013-01-01

    Objective To investigate the mechanism of topical tranexamic acid and its effects on skin barrier. Methods In the study, a chronic dermatitis was induced in BALB/c mouse, followed by the application of 5% tranexamic acid (tranexamic acid group) or distilled water (vehicle group) to the eruption once a day for fourteen days. Then data were obtained from two groups of mice with respect to their Transepidermal Water Loss (TEWL) , the expression of protein and mRNA of Filaggrin (FLG) , Involucrin (IVL) , Transglutami-nase 1 (TGM1) and Kallikrein7 (KLK7). Results Compared with the vehicle group [ (12. 10 ± 1. 33) g/(m2 · h)] , mice in the tranexamic acid group had significantly lower TEWL[ (9. 78 ±0. 54)g/( m2 · h)] ( P = 0.003) , and increased expression of FLG and IVL in epidermis. The mRNA level of FLG (269. 76 ± 140.02 vs 1 335. 80 ± 396. 34) and KLK7(113. 49 ±71. 80 vs 659.44 ± 368. 33) were significantly lower in the tranexamic acid group than that in vehicle group (P <0. 05). Conclusion Tranexamic acid may help the recovery of skin barrier by changing the expression of some protein involved in keratinocyte differentiation and desquamation.%目的 研究外用氨甲环酸对皮肤屏障功能的影响及其分子机制.方法 在BALB/c小鼠背部制备慢性皮炎模型,皮损处分别涂抹5%氨甲环酸水溶液(氨甲环酸组)及蒸馏水(基质组),1次/d,共14d.测定两组小鼠经表皮水分丢失量及丝聚蛋白、外皮蛋白、转谷氨酰胺酶1和激肽释放酶7的蛋白及mRNA表达情况.结果 与基质组[(12.10±1.33)g/(m2·h)]相比,氨甲环酸组小鼠背部皮损处经表皮水分丢失量[(9.78±0.54)g/(m2·h)]显著降低(P =0.003),而表皮丝聚蛋白、外皮蛋白表达强度增强.氨甲环酸组丝聚蛋白(269.76±140.02 vs 1 335.80±396.34)、激肽释放酶7(113.49±71.80vs 659.44±368.33)的mRNA表达量均显著低于基质组(P<0.05).结论 氨甲环酸可能通过影响某些角质形成细胞分化脱落相

  14. 乌司他丁及氨甲环酸联合应用抑制瓣膜置换术患者炎性因子及粒细胞弹性蛋白酶的临床研究%Combined ulinastatin and tranexamic acid provides beneficial effects by inhibiting inflammatory and fibrinolytic response in patients undergoing heart valve replacement surgery

    Institute of Scientific and Technical Information of China (English)

    陈婷婷; 王刚; 周琪; 张凌

    2012-01-01

    Objective To investigate the effect of ulinastatin and tranexamic acid administered alone or in combination on inflammatory cytokines and neutrophil elastase(NE) in patients undergoing heart valve replacement surgery during cardiopulmonary bypass (CPB). Methods One hundred and twenty patients undergoing heart valve replacement surgery during CPB were randomly assigned into 4 groups of 30 patients each: blank control group (Group C), tranexamic acid group (Group T), ulinastatin group (Group U) and tranexamic acid-ulinastatin combination group (Group D). Physiological saline, tranexamic acid, ulinastatin and a combination of tranexamic acid and ulinastatin were given to the groups respectively. Arterial blood was collected from the radial artery at four time points, that is, after induction of anesthesia (T1), un-clamping the ascending aorta (T2), at 1 h (T3) and 24 h (T4) after CPB. The levels of plasma tumor necrosis factor-alpha (TNF-α), interleukin 6 (IL-6), NE were observed and recorded. Results The plasma TNF-α, IL-6 and NE levels significantly increased in patients from all 4 groups at time points of T2, T3 and T4 in comparison to those before CPB (P < 0.05), while the plasma TNF-α and IL-6 levels in Groups U and D were significantly lower than those in other 2 groups (P < 0.05). Conclusions Ulinastatin inhibits the release of inflammatory factors and reduces the inflammatory response during CPB. Tranexamic acid exhibits a mild anti-inflammatory response.%目的 研究乌司他丁和氨甲环酸单独或联合应用在体外循环(CPB)心脏瓣膜置换手术中对炎性细胞因子及中性粒细胞弹性蛋白酶(NE)的影响.方法选择择期体外循环下行瓣膜置换术患者120例,随机分为空白对照组(C组)、氨甲环酸组(T组)、乌司他丁组(U组)以及联合用药(氨甲环酸+乌司他丁)组(D组),每组30例,分别给予生理盐水、氨甲环酸、乌司他丁及联合应用氨甲环酸及乌司他丁.于麻醉诱导后(T1)

  15. 局部应用氨甲环酸减少初次单侧全膝关节置换术后失血量的临床研究%Clinical research of local application of tranexamic acid to reduce the blood loss after primary unilateral total knee arthroplasty

    Institute of Scientific and Technical Information of China (English)

    李华贵; 常炳营; 王伟; 张丽欣; 郑晓梅

    2015-01-01

    目的:探讨局部应用氨甲环酸对初次单侧全膝关节置换术出血量的影响。方法:收治骨性关节炎行单侧全膝关节置换术患者68例,分为两组各34例:A组:局部灌注氨甲环酸,B组:局部灌注生理盐水。结果:A组与B组相比较,术后24 h、48 h引流量以及术后48 h血红蛋白量、血红蛋白下降百分比差异均具有统计学意义(P<0.05)。结论:在全膝关节置换术中局部应用氨甲环酸能明显减少患者失血量,且不增加静脉血栓形成的风险。%Objective:To investigate the effects of topical application of tranexamic acid for the blood loss after primary unilateral total knee arthroplasty.Methods:68 patients with osseous arthritis who had unilateral total knee arthroplasty were selected,they were divided into two groups with 34 cases in each:the A group:infusion of tranexamic acid,the B group:local perfusion of saline. Results:The A group compared with the B group,the difference of the postoperative 24h,48h lead traffic and the postoperative 48h hemoglobin,hemoglobin decreased rate had statistically significant(P<0.05).Conclusion:The topical application of tranexamic acid in total knee arthroplasty can decrease blood loss significantly and does not increase the risk of venous thrombosis.

  16. 全髋关节置换术关节内注射氨甲环酸预防术后失血的效果%Efficacy of intra-articular injection of tranexamic acid to reduce postoperative blood loss dur- ing total hip arthroplasty

    Institute of Scientific and Technical Information of China (English)

    黄涛; 刘世清

    2015-01-01

    Objective To discuss the effect of using tranexamic acid for prevention of postoperative intra-articular hemorrhage in total hip arthroplasty. Methods 58 patients with total hip arthroplasty were randomly divided into two groups, 29 cases in each group, the experimental group after skin closure intra-articular injection of tranexamic acid 1g/10ml saline,and the control group injected with saline 10ml. Postoperative hemoglobin concentration, drainage, transfusion rate, blood transfusion and complications were obscured. Results Compared with the control group,the reduce of hemoglobin difference preoperative and postoperative in the experimental group was lower(P0. 05). Conclusions Tranexamic acid can effectively reduce postoperative bleeding, but does not increase the in-cidence of complications.%目的:探讨全髋关节置换术中关节内注射氨甲环酸预防术后失血的效果。方法将58例全髋关节置换患者随机分为两组,每组29例。试验组缝皮后关节腔注射氨甲环酸(1 g溶于10 ml生理盐水),对照组注射生理盐水10 ml。观察术后血红蛋白浓度、引流量、输血率、输血量及并发症。结果与对照组比较,试验组手术前后血红蛋白差值少(P0.05)。结论氨甲环酸能有效减少术后出血,但并不增加并发症发生率。

  17. The clinical observation of optimal pulse technology therapy combined with intradermal injection of tranexamic acid on melasma%优化脉冲技术联合皮内注射氨甲环酸治疗黄褐斑临床观察

    Institute of Scientific and Technical Information of China (English)

    吴志波; 芦桂青; 孙慧; 李冬花; 李丙燕

    2016-01-01

    Objective To explore the clinical efifcacy and safety of optimal pulse technology (OPT) combined with intradermal injection of tranexamic acid on melasma. Methods Total of 74 patients with melasma were randomly divided into two groups,the OPT group and the combining group. OPT group (39 cases) only accepted the OPT treatment, the combining group (35 cases) accepted treatment with OPT and intradermal injection of ammonia tranexamic acid. After one course of treatment, clinical efifcacy and adverse reaction of both groups were observed. Results In the OPT group, the cure rate was 20.5%, the efifcient rate was 64.1%. In the combining group, the cure rate was 31.4%, the efifcient rate was 85.7%. There were signiifcantly difference between OPT group and combining group (P<0.05). Local injection of tranexamic acid had no obvious adverse reaction. Conclusion OPT with local intradermal injection of tranexamic acid are effective on the treatment of melasma without side effects.%目的:探讨优化脉冲技术(Optimal Pluse Technology, OPT)联合皮内注射氨甲环酸治疗黄褐斑的临床疗效及安全性。方法:将74例黄褐斑患者随机分为两组,分别为OPT组和联合组。OPT组:39例,仅接受OPT治疗;联合组:35例,接受OPT治疗的同时皮内注射氨甲环酸注射液,经过1个疗程治疗后观察疗效及不良反应。结果:OPT组治愈率20.5%,有效率64.1%;联合组治愈率31.4%,有效率85.7%,两组疗效比较具有统计学差异(P<0.05),局部注射氨甲环酸未见明显不良反应。结论:OPT联合局部皮内注射氨甲环酸注射液能有效治疗黄褐斑,且安全性高。

  18. Comparison and observation on the hemostatic effects of tranexamic acid injection and hemocoagulase injection in cervical cancer radical surgery%氨甲环酸注射液与注射用血凝酶在宫颈癌根治手术中止血效果的比较观察

    Institute of Scientific and Technical Information of China (English)

    张旭垠; 赵宇清

    2011-01-01

    目的:比较氨甲环酸注射液和注射用血凝酶在宫颈癌根治手术中的止血效果.方法:随机将40例宫颈癌Ⅰ b1期患者分成氨甲环酸组(20例)和注射用血凝酶组(20例).注射用血凝酶组于术前1天晚、术前1 h、15 min各肌肉注射1 kU;氨甲环酸注射液组于手术开始时及手术2 h时各静脉滴注1 g.比较两组患者手术时间,术中出血量,手术前后的凝血酶原时间(PT)、血红蛋白量(Hb)、血小板(PLT)、纤维蛋白降解产物(FDP).结果:两组患者手术时间、术后PT与术前比较差异均无统计学意义.氨甲环酸注射液组术中出血量小于注射用血凝酶组(P<0.05).两组患者术后Hb与术前相比均减少,但氨甲环酸注射液组减少量小于注射用血凝酶组(P<0.05).氨甲环酸注射液组术后FDP与术前比较差异无统计学意义,而注射用血凝酶组术后FDP较术前升高(P<0.05).注射用血凝酶组术后PLT少于术前(P<0.05).结论:氨甲环酸注射液术中止血效果优于注射用血凝酶,能有效减少宫颈癌根治手术术中出血量,并可能有潜在的预防DIC的作用.%Objective: To compare the hemostatic effects of tranexamic acid injection and hemocoagulase injection in cervical cancer radical surgery. Methods: 40 cases with cervical cancer of stage I b1 were divided into tranexamic acid injection group (20 cases) and hemocoagulase injection group (20 cases) . The cases in hemocoagulase injection group were treated with intramuscular injection of hemocoagulase ( 1 KU) on the day before operation, one hour and 15 minutes before operation; the cases in tranexamic acid injection group were treated with intravenous injection of tranexamic acid ( 1 g) at the beginning of the operation and two hours after the beginning. The operation times, the amounts of blood loss during pregnancy, prothrombin times (PTs) before and after treatment, the levels of hemoglobin ( Hb), the counts of platelets (PLT) and the levels of

  19. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... Clinical Trials In This Topic About Clinical Trials Risks and Benefits Terms to Know Finding a Clinical ... researchers may gather information about experimental treatments, their risks, and how well they work compare existing therapies ...

  20. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... the body laboratory tests that check samples of blood, urine, or other body tissues genetic tests that look for genes linked to some types of disease. Diagnostic Trials In diagnostic trials, researchers ...

  1. Research Areas - Clinical Trials

    Science.gov (United States)

    Information about NCI programs and initiatives that sponsor, conduct, develop, or support clinical trials, including NCI’s Clinical Trial Network (NCTN) and NCI Community Oncology Research Program (NCORP) initiatives.

  2. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... was provided by the National Library of Medicine Topic last reviewed: December 2013 For an enhanced version of this page please turn Javascript on. Participating in Clinical Trials About Clinical Trials A Research Study With Human Subjects A clinical trial is ...

  3. Organising trials by themes

    NARCIS (Netherlands)

    Hop, M.E.C.M.

    2013-01-01

    In recent years in the Netherlands the demand for a different type of cultivar trial has increased: the themed trial. Themed trials gather information on one property of a range of garden plants, like their winter hardiness or scent, or research the suitability of a range of plants for a specific us

  4. Understanding noninferiority trials

    Directory of Open Access Journals (Sweden)

    Seokyung Hahn

    2012-11-01

    Full Text Available Noninferiority trials test whether a new experimental treatment is not unacceptably less efficacious than an active control treatment already in use. With continuous improvements in health technologies, standard care, and clinical outcomes, the incremental benefits of newly developed treatments may be only marginal over existing treatments. Sometimes assigning patients to a placebo is unethical. In such circumstances, there has been increasing emphasis on the use of noninferiority trial designs. Noninferiority trials are more complex to design, conduct, and interpret than typical superiority trials. This paper reviews the concept of noninferiority trials and discusses some important issues related to them.

  5. 婴幼儿体外循环期间氨甲环酸血液浓度研究%Study of plasma concentration of tranexamic acid during cardiopulmonary bypass in infants with tetralogy of Fallot

    Institute of Scientific and Technical Information of China (English)

    孙国林; 李生德; 齐萍; 文仁国; 肖颖彬

    2013-01-01

    Objective To study the plasma concentration of tranexamic acid (TA) during cardiopul-monary bypass in infants with tetralogy of Fallot (TOF). Methods Five TOF infants with body weight of (7.36 ±2.08) kg were given an slow intravenous injection of initial dose of TA (100 mg/kg, 〉 10 min) before thoracotomy, following by another 100 mg/kg TA before the initiation of cardiopulmonary bypass (CPB). The concentration of TA was measured in blood plasma using 1H-NMR spectroscopy. Results Plasma TA concentrations were (224. 61 ± 195. 28) μg/mL before CPB (at 20 min after TA administration) , (509. 58 ± 181.57) μg/mL at 60 min after CPB initiation, and (243. 95 ±32. 30) μg/mL at the end of operation, respectively. The plasma TA concentration before CPB was not significantly different from that at 60 min after CPB initiation ( P = 0. 052) and that at the end of operation (P = 0. 83 ) , but there was significant difference between plasma TA concentration at 60 min after CPB initiation and that at the end of operation (P =0. 02). Conclusion A 100 mg/kg initial dose of TA followed by an infusion of 100 mg/kg before the initiation of CPB is sufficient enough to provide an effective plasma concentration, which is higher than 125 μg/mL for patients with high risk of bleeding, indicating the dose of TA can be decreased.%目的 研究婴幼儿法洛四联症(tetralogy of fallot,TOF)根治术体外循环(cardiopulmonary bypaass,CPB)期间应用氨甲环酸(tranexamic acid,TA)的血液浓度.方法 5例先天性TOF患儿,体质量(7.36±2.08)kg,在开胸前应用TA100 mg/kg,单次静脉缓慢注射(>10 min),CPB开始前再次注射100 mg/kg.应用磁共振波谱仪(1 H-NMR)方法,检测不同时间段TA的血液浓度.结果 CPB开始前(负荷剂量用药后约20 min)、CPB开始后1h、手术结束时的血液TA浓度分别为(224.61±195.28)、(509.58±181.57)、(243.95±32.30) μg/mL.CPB开始前与CPB开始后1h及手术结束时TA浓度比较均无统计学差异(P =0

  6. Effects of intraarticular tranexamic acid injection combined with 3-hour drainage tube occlusion postoperatively on blood loss in unicompartmental knee arthroplasty%氨甲环酸关节腔内注射联合置换后3 h夹闭引流管对膝关节单髁置换失血量的影响

    Institute of Scientific and Technical Information of China (English)

    曾兵; 刘刚; 贺志盛; 郑连杰; 荆丰博; 吕浩

    2016-01-01

    BACKGROUND:Unicompartmental knee arthroplasty has become mainstream operation for treatment of unicompartmental osteoarthritis of the knee, but unicompartmental knee arthroplastystil has some problems, such as excessive bleeding-induced postoperative blood transfusion, increased blood transfusion rate, hospitalization expense and complication of blood transfusion. As tranexamic acid for total knee arthroplasty has achieved good effects. It is significant to investigate whether local application of tranexamic acid can effectively reduce blood loss in unicompartmental arthroplasty. OBJECTIVE:To investigate the efficacy and safety of the intra-articular tranexamic acid injection in treating perioperative blood loss in patients undergoing unicompartmental knee arthroplasty. METHODS:122 patients with knee osteoarthritis undergoing unicompartmental knee arthroplastyinthe Department of Orthopedics, the Second Affiliated Hospital ofDalian Medical University from January 2014 to August 2015wereenroled in this study. Al patients were randomly divided into two groups. Patients in the tranexamic acid group were injected with 10 mL of tranexamic acid (containing 1000 mg) + 10 mL of sodium chloride injection in the articular cavity before loosening the tourniquet. Patients in the control group received 20 mL of sodium chloride injection in the articular cavity. In both groups, the drainage tube was clipped for 3 hours after injection.At 48 hours after replacement, the drainage tube was puled out. We compared and analyzed hemoglobin levels and hematocrit at 2 days and 1 month postoperatively, total blood loss and drainage volume at 2 days postoperatively, the number of patients receiving blood transfusion, Hospital for Special Surgery scores of knee function at 1 week and 1 month postoperatively, and thrombosis at 1 week postoperatively, and evaluated effects of tranexamic acid on blood loss after unicompartmental knee arthroplasty. RESULTS AND CONCLUSION:(1) Hemoglobin levels

  7. 初次单侧骨水泥型全膝关节置换:氨甲环酸使用方式对失血量的影响%Primary unilateral cemented total knee arthroplasty:effect of tranexamic acid usage on blood loss

    Institute of Scientific and Technical Information of China (English)

    侯振扬; 苏长征; 庞涛; 吕东; 朱彪; 孙义玲; 李振; 柴星宇; 许正文

    2015-01-01

      结果与结论:B组及C组患者显性失血量和隐性失血量均较A组明显减少,差异有显著性意义(P0.05),在隐性失血量方面B组显著小于C组(P OBJECTIVE:To explore and discuss the effect of tranexamic acid and different usage methods on blood loss in the perioperative period of primary unilateral cemented total knee arthroplasty. METHODS:Sixty patients who were candidates for unilateral cemented total knee replacement in the Second Department of Joint Sports Medicine, Tengzhou Central People’s Hospital, from January 2013 to June 2014, were included in this study. Al patients were randomly divided into three groups. Group A (n=20):patients were injected with 100 mL normal saline through intravenous drip when the operation began, and then with 10 mL normal saline through intra-articular injection after skin closure. Group B (n=20):patients were injected with 10 mg/kg tranexamic acid which was dissolved in 100 mL normal saline when the operation began, and then with 10 mL normal saline through intra-articular injection after skin closure. Group C (n=20):patients were injected with 100 mL normal saline when the operation began, and then with 500 mg tranexamic acid dissolved in 10 mL normal saline through intra-articular injection after skin closure. The dominant blood loss, hidden blood loss, blood transfusion ratio and per capita of each group were compared. Clinical symptoms of pulmonary embolism and lower limb deep vein thrombosis were observed. Doppler ultrasound examine on lower extremity would be performed if necessary. RESULTS AND CONCLUSION:Dominant and hidden blood loss of patients from groups B and C were significantly lower than that of patients from group A (P0.05), the hidden blood loss in group B was significantly less than that in group C (P<0.05). The transfusion population and ratio of patients from groups B and C were significantly lower than that of patients from group A (P<0.05). In al three groups, no deep

  8. Comparison of Effects on Intravenous and Intra-Articular Cavity Injection of Tranexamic Acid on Blood Loss Volume in Total Knee Arthroplasty%氨甲环酸不同途径用药对全膝关节置换术失血量的影响

    Institute of Scientific and Technical Information of China (English)

    石永进; 王全彬; 邱庆虎

    2016-01-01

    目的:分析氨甲环酸静脉滴注与关节腔内局部注射对控制全膝关节置换手术失血量的有效性及安全性.方法:选取2012年1月—2014年10月收治的行全膝关节置换术患者73例随机分为静脉滴注组40例和腔内注射组33例,静脉组在麻醉诱导期使用氨甲环酸10 mg/kg体重,最大剂量1 g;腔内组关节囊缝合完成且止血带未放松前,将氨甲环酸1 g注入关节腔.记录两组患者术后引流量、隐性失血量、凝血酶原时间(PT)、活化部分凝血活酶时间(APTT),观察患者是否出现下肢深静脉栓塞症状.结果:腔内组患者术后引流量(252±63)mL低于静脉组(545±61)mL,隐性失血量(603±59)mL低于静脉组(882±114)mL,差异具有统计学意义.腔内组患者PT、APTT、INR与静脉组比较差异无统计学意义(P>0.05).每组1例发生深静脉血栓.结论:关节腔内注射氨甲环酸,能有效控制全膝关节置换术后失血量,且相对安全,并不增加术后深静脉血栓发生机率.%Objective To compare the effects and operative safety of intravenous drip and intra-articular cavity local injection of tranexamic acid on controlling blood loss volume in total knee arthroplasty. Methods Totally 73 patients with total knee arthroplasty treated in the hospital from January 2012 to October 2014 were randomly divided into the intravenous drip group(IVTA)(40 cases) and the intra-articular use group(IATA) (33 cases). The patients in the control group used intravenous tranexamic acid 10 mg/kg,with the maximum dose 1.0g during the anesthetic induction period,while the patients in the treatment group were intra-articularlly injected by tranexamic acid 1g at the finishing of articular capsule suture and before relaxing the tourniquet.The postoperative blood loss,the hidden blood loss,prothrombin time (PT),activated partial thromboplastin time (APTT) were recorded for both groups. Deep-vein thrombosis (DVT) were observed. Results The postopera

  9. 氨甲环酸静脉滴注联合关节腔注射对初次全膝关节置换患者术后出血量的影响%Effects of intravenous and intra - articular tranexamic acid on postoperative blood loss of primary total knee arthroplasty

    Institute of Scientific and Technical Information of China (English)

    王英明; 孔荣; 禹德万; 朱晨

    2015-01-01

    目的:探讨氨甲环酸静脉滴注联合关节腔注射对初次行全膝关节置换患者术后出血量的影响。方法以2015年1月至2015年5月收治的45例重度膝骨关节炎行初次全膝关节置换的患者为研究对象,随机分为氨甲环酸组(23例)与对照组(22例)。氨甲环酸组术中松止血带前30 min 静脉应用氨甲环酸10 mg/ kg,并于手术结束后经引流管向关节腔注射1.0 g 氨甲环酸,夹闭引流管4 h,弹力绷带包扎。对照组的处理为给予相应量的生理盐水。观察两组患者术后24 h、48 h 引流量并于术后第3天复查血常规。结果氨甲环酸组术后切口引流量平均约220 mL,与对照组450 mL 相比,差异有统计学意义(P <0.05)。术后第3天复查血红蛋白的降低程度,氨甲环酸组降低约12.9 g/ L,明显小于对照组23.5 g/ L,且差异有统计学意义(P <0.05)。结论氨甲环酸静脉滴注联合关节腔注射可以明显降低初次全膝关节置换患者术后出血量。%Objective To investigate the effect of intravenous and intra-articular tranexamic acid on postoperative blood loss of pri-mary total knee arthroplasty(TKA). Methods From Jan 2015 to May 2015,45 patients who received primary TKA due to severe knee os-teoarthritis were randomly allocated to tranexamic acid(TA)group(n = 23)and control group(n = 22). Patients in the TA group received intravenous tranexamic acid 10 mg/ kg at 30 min before tourniquet release and 1. 0 g tranexamic acid intra-articular injection through the drain tube rightly after wound closure,followed by drain tube clip for 4 hours and pressured elastic bandage. The corresponding amount of saline was administered in the control group. The volume of drainage was recorded at 24 and 48 hours after operation,and haemoglobin level was in-spected again at 3 days after operation. Results Compared with 450 ml drainage fluid in the control group,the mean volume of drainage

  10. Study of effectiveness and safety of tranexamic acid in reducing blood loss and blood transfusion rate of elderly hip fracture surgery%氨甲环酸减少老年髋部骨折手术失血量与输血率的有效性及安全性研究

    Institute of Scientific and Technical Information of China (English)

    杨明新; 于华; 赵金红; 苏杰

    2015-01-01

    Objective To investigate the effectiveness and safety of preoperative intravenous administration of tranex-amic acid in the hemiarthroplasty treatment of elderly hip fracture. Methods Seventy patients who received hemiarthro-plasty due to femoral neck fracture (Garden Ⅲ/Ⅳ) in our hospital from January 2008 to December 2012 were analyzed retrospectively, of which 35 patients were given preoperative intravenous administration of tranexamic acid and 35 pa-tients were not. The patients'preoperative and postoperative hemoglobin and hematocrit values were collected. The to-tal blood loss amount was calculated through Gross equation and the postoperative drainage amount, number of people receiving blood transfusion, blood transfusion amount and occurrence of thrombus events were recorded. Results The total blood loss amount of the tranexamic acid group was (867.79±76.93) mL, which was significantly lower than (1207.07±403.83) mL of the control group, with statistically significant difference(P=0.036). The postoperative drainage amount was (305.67±103.68) mL, which was lower than the (393.00±66.29) mL of the control group, with statistically significant difference (P<0.01). The application of tranexamic acid decreased the blood transfusion rate from 42.86% to 20.00%(P=0.039). The complications of postoperative thrombus events did not increase (P=0.643). Conclusion In the treatment of elderly femoral neck fracture, the preoperative intravenous administration of tranexamic acid can effec-tively and safely reduce the blood loss amount and blood transfusion rate of hemiarthroplasty.%目的:探讨术前静脉使用氨甲环酸在半髋关节置换术治疗老年髋部骨折中的有效性与安全性。方法回顾性分析我院2008年1月~2012年12月因股骨颈骨折(GardenⅢ/Ⅳ型)行半髋关节置换术患者70例,其中35例术前静脉使用氨甲环酸,35例未使用。收集患者的术前、术后血红蛋白及血细胞比容值,通过Gross方程计算

  11. 关节腔内灌注氨甲环酸降低全膝关节置换手术出血的前瞻性随机对照研究%Effects of tranexamic acid in total knee arthroplasty by intra-articular injection on reducing blood loss:a prospective randomized controlled study

    Institute of Scientific and Technical Information of China (English)

    闵令田; 翁文杰; 邱勇; 王渭君; 袁涛; 吴明达; 李佳怡; 刘飞

    2014-01-01

    目的:探讨关节腔内注射氨甲环酸在减少全膝关节置换术后出血的疗效和安全性。方法选取符合纳入标准的患者60例,采用RandA 1.0软件随机平均分为两组。氨甲环酸组于术后关节腔内注射50 ml溶有3.0 g氨甲环酸的生理盐水,夹闭引流管1 h后负压吸引;对照组则术后通过引流管直接向关节腔注入生理盐水50 ml,夹闭引流管1 h后负压吸引。术后三日每天复查患者血常规、凝血指标,并记录每日引流量,术后3~5d行下肢静脉造影,观察血栓发生率。结果氨甲环酸组术后3d总的引流量以及总失血量明显少于对照组。氨甲环酸组输血人数明显小于对照组。两组患者在术后凝血功能、血栓发生率及术后不良事件方面差异无统计学意义。结论全膝关节术后关节腔内注射氨甲环酸可有效减少出血量,并不增加血栓发生概率。%Objective To assess the efficacy and safety of tranexamic acid in reducing the blood loss during the primary total knee arthroplasty ( TKA ) by intra-articular injection . Methods A prospective randomized controlled study was carried out , including 60 patients who underwent the primary TKA by the same surgeon team on a standardized technique .Each group instantly accepted 50 ml normal saline intra-articular injection postoperatively with 3.0 g tranexamic acid dissolved in or not .Each patient had negative pressure drainage after the drainage-tube clamped for one hour and received the blood routine examination and the blood coagulation indicator test; their daily drainage in the first three days was recorded postoperatively .The vein angiography of the lower limb was carried out within 3 -5 days to observe the incidence of thrombosis .Results The postoperative drainge and the total blood loss in the tranexamic acid group were significantly less than the control group .The number of the patients accepted transfusion in the tranexamic group was

  12. Efficacy and safety of single preoperative dose tranexamic acid use for perioperative blood loss control in patients having primary total hip arthroplasty%术前单一剂量氨甲环酸对初次全髋关节置换术围手术期失血的影响及安全性评估

    Institute of Scientific and Technical Information of China (English)

    张弛; 乔志; 刘宏建; 殷力; 张宜远; 王义生

    2014-01-01

    目的 探讨使用氨甲环酸是否能够安全、有效地减少全髋关节置换术围手术期的出血量和输血率.方法 将100例行全髋关节置换术患者随机平均分为两组,氨甲环酸组于切皮前15 min将氨甲环酸按20 mg/kg单一剂量静脉输注,对照组同时间点给予等量生理盐水.对比术后2d的血红蛋白减少量、输血量、输血人数和术后静脉血栓形成风险的差异.结果 氨甲环酸组患者血红蛋白减少量、输血量和输血人数分别为(44.3±13.2) g/L、(338.8 ±92.7) ml、13例(26%),低于对照组的(53.4±8.9) g/L、(459.7±188.5)ml、29例(58%,P<0.05);两组患者术后深静脉血栓发生率差异无统计学意义(P>0.05).结论 氨甲环酸能够减少全髋关节置换术患者围手术期的出血量和输血率,不增加术后血栓形成的风险.%Objective To investigate the efficacy and safety of single preoperative dose tranexamic acid use for perioperative blood loss control in patients having primary total hip arthroplasty.Methods One hundred patients having primary total hip arthroplasty were randomly divided into 2 groups,the tranexamic acid group and the control group,with 50 patients in each.In the tranexamic acid group,a single dose of 20 mg/kg was infused intravenously within 15 minutes before skin incision,while an equal volume of normal saline was given instead in the control group.Hemoglobin losses,blood transfusion volume and blood transfusion rate of these two groups were measured before and two days after operation,the comparative analysis was conducted.Deep vein thrombosis was also observed in these two groups.Results Hemoglobin losses,blood transfusion volume and blood transfusion rate in the tranexamic acid group were (44.3 ± 13.2) g/L,(338.8 ±92.7) ml,13 (26%),lower than the control group (53.4 ± 8.9) g/L,(459.7 ± 188.5) ml,29 (58%) (P < 0.05); while no significant difference was detected in the incidence of venous thrombosis (P > 0

  13. Comparability of prostate trials

    DEFF Research Database (Denmark)

    Suciu, S; Sylvester, R; Iversen, P;

    1993-01-01

    The present overview of advanced prostate cancer required the identification of randomized clinical trials studying the question of maximal androgen blockade versus the classic castration therapy. The heterogeneity of the trials concerned the type of castration (surgical or chemical) and the type...... of antiandrogen (flutamide, Anandron, or cyproterone acetate) added to castration. This paper reviews the different types of heterogeneity that might exist among trials that are involved in the overview: study design, randomization procedure, treatment evaluation, statistical evaluation, and data maturity...

  14. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... on their phase. The U.S. Food and Drug Administration typically requires Phase 1, 2 and 3 trials ... 000 people. If the U.S. Food and Drug Administration agrees that the trial results are positive, they ...

  15. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... In This Topic About Clinical Trials Risks and Benefits Terms to Know Finding a Clinical Trial Informed ... for more information Scientists usually do years of experiments in the laboratory and in animals before they even consider testing an experimental treatment ...

  16. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... disease or prevent a disease from returning. Supportive Care Trials In supportive care trials, researchers look for ways to make life ... groups, and various types of social interventions. Supportive care interventions are not intended to treat or cure ...

  17. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... care trials, researchers look for ways to make life better for people living with a life threatening disease or chronic health problem. The goal ... IV trial for drugs or devices takes place after the U.S. Food and Drug Administration approves their ...

  18. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... In This Topic About Clinical Trials Risks and Benefits Terms to Know Finding a Clinical Trial Informed ... years of experiments in the laboratory and in animals before they even ... this early research occurs at universities and medical centers across the ...

  19. The Comparison of Efficacy and Safety between Aprotinin and Tranexamic in Pediatric Cardiac Surgery%抑肽酶和氨甲环酸在儿科先心手术中应用的疗效与安全性比较

    Institute of Scientific and Technical Information of China (English)

    王丽红; 邓萌; 张学锋; 周守静; 梁伟民

    2011-01-01

    Objective:To examine the benefits, risk of aprotinin compared to tranexamic acid in pediatrics cardiac surgery with cardiopulmonary bypass (CPB). Methods: Perioperative data of 557 patients undergoing open-heart cardiac surgery with CPB were collected between July 2007 and July 2008. During the first 6 months, 265 patients received aprotinin; in the next 6 months, 292 patients were treated with tranexamic acid. We divided all 557 patients into two groups, the complexity procedure group (n = 156) and the low complexity procedure group (n = 401 ). In low complexity procedure, two subgroups were set by patients <10kg and patients > 10kg. Aprotinin and tranexamic acid were compared in each procedure group and subgroup. Demographics and baseline laboratory findings, total blood loss and transfusion requirements during the period from protamine administration until 24h after admission to intensive care unit (ICU) and relevant laboratory findings were recorded. Postoperative complications and in-hospital mortality were also considered as outcome parameters. Results : Children who were treated with aprotinin had 21% less 24h blood loss compared with children who received tranexamic acid in complexity procedure group[9.6 (7.5-17.5)ml/kg vs 12.1 (6. 2-17)ml/kg](P<0. 05). No significant difference was found in low complexity procedure group.Also, no significant differences were observed in the postoperative transfusion requirements and rates, as well as the incidence of the postoperative complications and in-hospital mortality between the two treatment groups within each procedure group.Conclusions: Aprotinin was more effective than tranexamic acid in reducing 24h blood lose during complexity congenital heart defects procedure. There were no significant differences in risks of renal dysfunction, CNS complication or in-hospital mortality between aprotinin and tranexamic acid.%目的:评价抗纤溶药物抑肽酶和氨甲环酸在儿科先心手术中应用的安全

  20. 全膝关节置换后静脉与局部应用氨甲环酸对失血量的影响%Effects of intravenous versus topical application of tranexamic acid on blood loss following total knee arthroplasty

    Institute of Scientific and Technical Information of China (English)

    柴星宇; 苏长征; 庞涛; 吕东; 朱彪; 侯振扬; 李振; 许正文; 赵廷宝

    2015-01-01

    背景:目前关于全膝关节置换过程中使用氨甲环酸减少出血的报道越来越多,但对于使用方式的选择仍存在争议。  目的:通过术中关节腔周围组织局部注射和静脉注射两种不同的给药途径,探讨氨甲环酸对初次单侧全膝关节置换后失血量的影响。  方法:根据随机对照原则设计,选取滕州市中心人民医院2013年10月至2014年12月收治拟行单侧全膝关节置换的患者90例,随机分为静脉组和局部组(n=45)。静脉组患者在全身麻醉诱导期接受静脉输注氨甲环酸(10 mg/kg 最大剂量1.2 g);局部组于假体安装结束后,缝合关节囊前,在关节周围软组织注射氨甲环酸(2 g溶于50 mL生理盐水)。比较两组患者置换后引流量、置换后次日血红蛋白及红细胞压积、输血例数,同时观察是否有肺栓塞及下肢深静脉栓塞的临床症状出现,必要时行下肢血管多普勒超声检查。  结果与结论:置换后引流量、置换后次日血红蛋白值及红细胞压积、输血人数及输血比率比较,两组差异无显著性意义(P>0.05)。两组患者置换后14 d 均未发现下肢深静脉血栓形成。提示与静脉全身应用相比,全膝关节置换过程中关节周围局部应用氨甲环酸同样能达到有效减少置换后失血和输血的效果,并可避免静脉应用氨甲环酸可能带来的相关并发症。%BACKGROUND:Increasing reports have focused on the application of tranexamic acid to reduce bleeding during total knee arthroplasty, but its usage method remains controversial. OBJECTIVE:To explore the impact of topical articular application of tranexamic acid and intravenous application of tranexamic acid on blood loss during primary unilateral total knee arthroplasty. METHODS:According to randomized control ed principle, 90 patients who received unilateral total knee arthroplasty in the Tengzhou Central People’s Hospital from

  1. Aspirin and local application of tranexamic acid reduce blood loss for simultaneous bilateral total knee arthroplasty%双侧同期全膝关节置换术患者阿司匹林结合氨甲环酸局部应用有效性与安全性的回顾研究

    Institute of Scientific and Technical Information of China (English)

    顾建明; 潘盈; 杜辉; 蒋毅; 周一新

    2016-01-01

    目的:研究阿司匹林结合关节腔内应用氨甲环酸在减少同期双侧人工全膝关节置换术围手术期出血的有效性和安全性。方法将2012年1月至2015年1月,同期行双侧人工全膝置换术患者101例分为观察组与对照组。45例未使用氨甲环酸为对照组,使用氨甲环酸的56例为观察组。观察组患者在骨水泥固定后关节内喷洒氨甲环酸1 g (10 ml )。术后使用阿司匹林预防静脉血栓。记录两组患者的性别,男女比例,体重指数,术前血容量,术前血红蛋白水平以及血小板计数,再比较两组患者术后总失血量、有无输血、输血量以及有无症状性静脉栓塞( VTE )发生。结果氨甲环酸组和对照组在术后第1天总失血量分别为729.0 ml 和1163.0 ml,术后第5天总失血量为915.8 ml 和1358.2 ml,总输血量3.1 U 和4.2 U,输血率为92.9%和100.0%,观察组数据显著低于对照组(P<0.05)。观察组术后第5天的血红蛋白水平(1108 g / L )明显高于对照组(982 g / L )(P<0.05)。两组患者术后血小板计数[(159.4±44.4)×109/ L 和(165.4±45.7)×109/ L ]差异无统计学意义(P>0.05)。两组患者术后均未发生症状性静脉血栓。结论同期双侧人工全膝关节置换术局部使用氨甲环酸可以有效减少出血量,且不增加血栓发生风险。%Objective To investigate the efifcacy and safety of aspirin in combination with local tranexamic acid for simultaneous bilateral total knee arthroplasty.Methods From Jan. 2012 to Jan. 2015, 101 simultaneous bilateral TKA were retrospectively analyzed. Local application of tranexamic acid was given in 56 cases. Control group involved 45 cases without tranexamic acid uses. Aspirin was given for prevention of deep vein thrombosis. Total blood loss, transfusion volume, transfusion rate and venous thromboembolism were recorded and compared.Results Total blood loss in post-operative day one and ifve, transfusion volume

  2. Research of affection for blood loss in different ways to use tranexamic acid in total hip arthroplasty%氨甲环酸的使用方式对全髋置换术显隐性失血影响的研究

    Institute of Scientific and Technical Information of China (English)

    王剑; 谢飞; 刘先齐; 赵建军; 李茂生; 冷通国; 林洪伟

    2015-01-01

    目的:通过分组对照实验,探讨氨甲环酸的不同使用方式对全髋关节置换术(THA)显隐性失血的影响。方法病例选自该院骨科2010年3月至2013年8月共60例患者。诊断:股骨颈骨折47例,股骨头坏死13例;年龄45~82岁,平均62岁,均接受单侧T H A。所有病例分为A组、B组和C组共3组,各20例,经过筛选,每组男性6例,女性14例,均为初次全髋置换。A组术前0.5 h、术后3 h分别予100 mL生理盐水静滴;B组术前0.5 h将氨甲环酸按10 mg/kg稀释于100 mL生理盐水中静滴,术后3 h予100 mL生理盐水静滴;C组术前0.5 h、术后3 h分别将氨甲环酸按10 mg/kg稀释于100 mL生理盐水中静滴。计算各组患者的显性及隐性失血量,并进行统计学分析,探讨实验组中氨甲环酸2种使用方式的有效性及安全性。结果显性红细胞丢失量:A组(196.20±44.45)m L ,B组(114.84±35.21)m L ,C组(104.47±30.01)m L ;隐性红细胞丢失量:A组(614.50±98.41)m L ,B组(425.74±70.01)m L ,C组(337.12±52.23)m L。结论氨甲环酸的使用能明显减少T H A的显隐性失血量,术前0.5h合并术后3h使用较术前0.5h使用对减少隐性失血量效果更佳,进一步减少输血量,且不会明显增加下肢深静脉血栓形成的发生率。%Objective To explore the influence of tranexamic acid used in different modes in total hip arthroplasty (T HA ) blood loss by control experiment .Methods 60 patients accepted total hip arthroplasty from orthopaedics in our hospital were se‐lected between March 2010 to August 2013 ,among them femoral neck fracture were 47 cases and 13 cases were osteonecrosis .aged between 45‐82 years old ,and 62 in average .All gave unilateral total hip arthroplasty .All patients were divided into three groups ,A group(contradistinction group) ,B ,C group(experiment group) .each groups include 6 men

  3. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    Kraus, V B; Blanco, F J; Englund, M;

    2015-01-01

    The objective of this work was to describe requirements for inclusion of soluble biomarkers in osteoarthritis (OA) clinical trials and progress toward OA-related biomarker qualification. The Guidelines for Biomarkers Working Group, representing experts in the field of OA biomarker research from...... both academia and industry, convened to discuss issues related to soluble biomarkers and to make recommendations for their use in OA clinical trials based on current knowledge and anticipated benefits. This document summarizes current guidance on use of biomarkers in OA clinical trials...... and their utility at five stages, including preclinical development and phase I to phase IV trials. As demonstrated by this summary, biomarkers can provide value at all stages of therapeutics development. When resources permit, we recommend collection of biospecimens in all OA clinical trials for a wide variety...

  4. Clinical Study of Topical Application of Tranexamic Acid Blood Quantity and Safety of Primary Unilateral Knee Replacement in Perioperative Period%氨甲环酸局部应用对初次单侧膝关节置换围手术期失血量及安全性影响的临床研究

    Institute of Scientific and Technical Information of China (English)

    林祥波; 王建然; 李常辉; 王代宪; 陈波

    2016-01-01

    目的:对初次单侧膝关节置换围手术期局部应用氨甲环酸对出血量的影响进行探讨,并掌握其用药安全性。方法以我院关节外科收治的40例初次单侧膝关节置换术患者作为研究对象,随机分成M组和N组,均为20例;M组局部应用氨甲环酸;N组局部应用生理盐水,对两组的失血量及术后并发症发生情况予以分析。结果两组术后24 h、48 h的引流量、血红蛋白水平及术后总失血量,差异均有统计意义(P<0.05);在治疗中两组均未出现不良反应。结论在初次单侧膝关节置换围手术中,局部应用氨甲环酸可有效减少围术期失血量,促进患者术后恢复,未增加感染、静脉血栓发生风险,安全性较高。%Objective For primary unilateral knee replacement around tranexamic acid on blood loss affect the operation of the local application of ammonia to explore, and master their drug safety. Methods 40 cases of primary unilateral knee replacement patients in joint surgery in our hospital were chose as research subjects, were randomly divided into groups M and N group, 20 cases in each group, M group topical application of tranexamic acid, N group topical application of saline, two groups of blood loss and postoperative complications were to be analyzed. Results Two groups of postoperative 24 h, 48 h of the drainage volume, hemoglobin level and total blood loss, the difference was statistically signiifcant (P<0.05), in the treatment of the two groups were not adverse reactions. Conclusion In primary unilateral knee replacement surgery around, the local application of tranexamic acid may be effective in reducing perioperative blood loss, postoperative recovery promote me, did not increase the infection, the risk of venous thrombosis, high security.

  5. Influence of acute non-isovolemic hemodilution plus tranexamic acid on coagulation factors and hemorrhage%急性非等容量血液稀释联合氨甲环酸对凝血因子和失血量的影响

    Institute of Scientific and Technical Information of China (English)

    朱玉民; 骆喜宝; 刘志贵; 覃祥玲; 黄志华; 王菲; 翟庶文

    2015-01-01

    Objective To study the effect of acute non-isovolemic hemodilution (ANIH) plus tranexamic acid on bleeding and coagulation factors. Methods Forty-two patients with brain tumor under general anesthesia were randomly divided into group N and group T with 21 patients in each group. Group N was given ANIH , while group T was given tranexamic acid and ANIH. Bleeding, transfusion, urine volume were recorded. Coagulation factors and D-dimer were detected one day before and after surgery. Hemoglobin was recorded before and after ANIH and after auto-blood was transfused. Results There was less bleeding in group T. Hemoglobin in group T was higher after transfusion. No significant difference was found in Group T and group N in terms of urine volume and transfusion rate. Both the two groups had no difference on variation of coagulation factors. Conclusion ANIH with tranexamic acid has no significant effect on coagulation but produces synergetic effect on decreasing bleeding. They can be applied in surgery of brain tumor safely.%目的:探讨在脑肿瘤手术中急性非等容量血液稀释(CANIH)联合氨甲环酸应用对凝血因子和失血量的影响。方法:择期全麻脑肿瘤手术患者42例,分为N组和T组,每组21例。 N组只进行ANIH,T组采用ANIH和氨甲环酸联合应用。记录术中失血量、输血量、输液量和尿量,记录术前1 d和术后1 d凝血功能指标以及D-二聚体的变化,记录分析ANIH前、ANIH后和自体血回输后血红蛋白的变化。结果:T组失血量较N组少,自体血回输后,T组血红蛋白高于N组。T组和N组尿量和输血量无明显差异。两组对凝血因子影响不大。结论:ANIH联合氨甲环酸可以产生协同节血效果,对凝血功能影响不大,可以安全用于脑肿瘤手术。

  6. Impaction of iron supplement combined with tranexamic acid on perioperative blood loss and safety of unilateral total knee ar-throplasty%铁剂与氨甲环酸联合应用对单侧全膝关节置换术围手术期失血及安全性的影响

    Institute of Scientific and Technical Information of China (English)

    孟涛; 尚希福

    2015-01-01

    Objective To explore and discuss the efficacy and safety of iron supplement combined with tranexamic acid in reducing perioperative blood loss of unilateral total knee arthroplasty(TKA). Methods 142 patients suffered from unilateral knee osteoarthritis and underwent primary TKA in our hospital from July to December in 2014 were enrolled in this study,then they were randomly divided into study group(76 cases)and control group(66 cases). Besides the same treatment as the control group,patients in the study group were given oral iron supplement during 2 weeks before and after the operation,and during the operation they received intra - articular injection of tranexamic acid(1. 0 g)and 20 mL normal saline after suturing and intravenous tranexamic acid(15 mg/ kg)at 20 min before tourniquet release. The amounts of intraoperative blood loss,hidden blood loss,total blood loss and postoperative drainage,the number of patients needing blood transfusion,the operation time,and results of blood Hb,Hct,PT,APTT,FIB of the two groups before and after the operation were recorded and analyzed. Results The differences of preoperative general conditions and examinations of patients were of no statistically significant be-tween the two groups(P > 0. 05). There was no significant difference in operation time,intraoperative blood loss and postoperative levels of PT,APTT and FIB between the two groups(P > 0. 05). Results of Hb and Hct of the study group at 1 day,3 days,2 weeks after operation were significantly higher than those of the control group(P 0.05);两组患者手术时间、术中失血量、术后 FIB、PT、APTT 比较,差异无统计学意义(P >0.05),观察组术后1天、3天、2周时 Hb 及 Hct 均高于对照组(P <0.05),观察组术后引流量、隐性失血量、总失血量及输血人数均少于对照组(P <0.05)。结论联合应用铁剂和氨甲环酸可安全、有效地减少单侧 TKA 围手术期的失血,促进患者术后 Hb、Hct 水平的恢复。

  7. Clinical efficacy observation of intravenous drip of tranexamic acid injection combined with glutathione and Vitamin C in patients with chloasma%氨甲环酸注射液联合谷胱甘肽及维生素C治疗黄褐斑的近期临床观察

    Institute of Scientific and Technical Information of China (English)

    陈姮如; 邓列华

    2014-01-01

    目的:对氨甲环酸注射液联合谷胱甘肽及维生素C静滴治疗黄褐斑的临床疗效进行评价。方法将100例面部黄褐斑的患者分为两组。治疗组使用氨甲环酸0.25g注射液+谷胱甘肽1.2g+维生素C 5g静脉滴注8周。对照组仅用谷胱甘肽1.2g+维生素C 5g静脉滴注8周。结果治疗组总有效率为92%,对照组总有效率62%。两组疗效比较,差异有统计学意义(P<0.05)。结论氨甲环酸注射液联合谷胱甘肽及维生素C静滴治疗黄褐斑比单用谷胱甘肽1.2g+维生素C的疗效更好。%Objective To evaluate the clinical efficacy of intravenous drip of tranexamic acid injection combined with glutathione and vitamin C in patients with chloasma. Methods 100 patients with facial melasma were divided into two groups. The treatment group was given intravenous drip of 0.25g tranexamic acid injection combined with 1.2g glutathione and 5 g vitamin C for 8 weeks, and the control group was given intravenous drip of 1.2 g glutathione and 5 g vitamin C for 8 weeks. Results The total effective rate of treatment group and control group was 92% and 62% respectively, and the difference was statistically significant (P < 0.05). Conclusion The intravenous drip of tranexamic acid injection combined with glutathione and vitamin C is more effective in treating chloasma than the application of glutathione and vitamin C.

  8. Fundamentals of clinical trials

    CERN Document Server

    Friedman, Lawrence M; DeMets, David L; Reboussin, David M; Granger, Christopher B

    2015-01-01

    This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise.  Most chapters have been revised considerably from the fourth edition.  A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded.  Many contemporary clinical trial examples have been added.  There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing, and international trials.  This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of ...

  9. Comparability of prostate trials

    DEFF Research Database (Denmark)

    Suciu, S; Sylvester, R; Iversen, P;

    1993-01-01

    The present overview of advanced prostate cancer required the identification of randomized clinical trials studying the question of maximal androgen blockade versus the classic castration therapy. The heterogeneity of the trials concerned the type of castration (surgical or chemical) and the type...... of antiandrogen (flutamide, Anandron, or cyproterone acetate) added to castration. This paper reviews the different types of heterogeneity that might exist among trials that are involved in the overview: study design, randomization procedure, treatment evaluation, statistical evaluation, and data maturity...... with a larger number of patients and a longer follow-up will contribute more to the overview's results....

  10. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... experimental drug, therapy, medical device, lifestyle change, or test will help treat, find, or prevent a disease. A clinical trial may compare experimental products or tests to those already available or may compare existing ...

  11. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... out if an experimental drug, therapy, medical device, lifestyle change, or test will help treat, find, or ... specific medical problem. These trials find out if lifestyle changes, such as exercising more, getting more sleep, ...

  12. Anchor Trial Launch

    Science.gov (United States)

    NCI has launched a multicenter phase III clinical trial called the ANCHOR Study -- Anal Cancer HSIL (High-grade Squamous Intraepithelial Lesion) Outcomes Research Study -- to determine if treatment of HSIL in HIV-infected individuals can prevent anal canc

  13. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... radiotherapy. Click for more information Scientists usually do years of experiments in the laboratory and in animals ... term side effects. This phase can last several years. A Phase III trial gathers more information about ...

  14. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... Clinical Trials Videos quiz yourself MedlinePlus for More Information National Institute on Aging Related Topics Talking with Your Doctor Taking Medicines The information in this topic was provided by the National ...

  15. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... Drug Administration typically requires Phase 1, 2 and 3 trials to be conducted to determine if the ... subjects usually ranges from several hundred to about 3,000 people. If the U.S. Food and Drug ...

  16. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    Katz, J N; Losina, E; Lohmander, L S

    2015-01-01

    To highlight methodological challenges in the design and conduct of randomized trials of surgical interventions and to propose strategies for addressing these challenges. This paper focuses on three broad areas: enrollment; intervention; and assessment including implications for analysis. For eac...

  17. ClinicalTrials.gov

    Data.gov (United States)

    U.S. Department of Health & Human Services — Provides patients, family members, health care professionals, and members of the public easy access to information on clinical trials for a wide range of diseases...

  18. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... Learn More Participating in Clinical Trials Videos quiz yourself MedlinePlus for More Information National Institute on Aging Related Topics Talking with Your Doctor Taking Medicines The information in ...

  19. Polyp Prevention Trial

    Science.gov (United States)

    The primary objective of the Polyp Prevention Trial (PPT) is to determine whether a low fat, high fiber, high vegetable and fruit eating plan will decrease the recurrence of adenomatous polyps of the large bowel.

  20. Hemostatic effect of local application and intravenous application of tranexamic acid in total knee arthroplasty%氨甲环酸在全膝关节置换术中局部应用和静脉应用的止血效果比较

    Institute of Scientific and Technical Information of China (English)

    席少华; 周朝波; 赵桂林

    2015-01-01

    目的:比较氨甲环酸局部应用和静脉应用在减少全膝关节置换术患者出血量方面的效果和安全性。方法选择2012年6月至2013年12月符合标准的行初次单侧全膝关节置换术的100例患者。局部应用氨甲环酸术中止血的47例患者作为A组,静脉使用氨甲环酸术中止血的53例患者作为B组。分别记录两组术中出血量、术后失血量、输血例数、输血量、术后第1、3、5天血红蛋白值、红细胞压积、术前和术后3h纤维蛋白原、凝血酶原时间、活化的部分凝血酶原时间、D-二聚体,术后5~7d 双下肢静脉超声筛查有无深静脉血栓( DVT)。结果 A组术后引流量、总失血量、输血量少于B组,未输血患者术后1、3、5 d血红蛋白值高于B组,差异有统计学意义(P0.05);术后经双下肢静脉超声检查均未见下肢深静脉血栓,术后随访均无下肢深静脉栓塞和肺栓塞。结论全膝关节置换术中局部应用氨甲环酸和静脉应用比较能明显减少术后出血量、降低输血量,二者均不增加DVT形成的风险。%Objective To compare the efficacy and safety of tranexamic acid local use and intravenous use in reducing blood loss of patients who received total knee arthroplasty ( TKA ) . Methods A hundred patients who re-ceived primary unilateral TKA from June 2012 to December 2013 were analyzed retrospectively. Patients in group A (n=47) received local application of tranexamic acid,and patients in group B (n=53) were given tranexamic acid in-travenously. The amounts of intraoperative blood loss,postoperative visible blood loss,the number of patients needed blood transfusion,blood transfusion volume,hemoglobin at 1,3,5 d after operation,hematocrit,preoperative and post-operative 3 h fibrinogen,PT,APTT,D-dimer were recorded respectively. The lower limbs venous ultrasound was used to screen for patients with DVT at 5~7 d after operation. Results The postoperative suction

  1. Comparison of Effects on Intravenous and Intra-Articular Cavity Injection of Tranexamic Acid on Blood Loss Volume in Total Knee Arthroplasty%静脉与关节腔内使用氨甲环酸对全膝关节置换术失血量的影响比较

    Institute of Scientific and Technical Information of China (English)

    蒋华; 颜宇; 马红兵; 曾勇; 徐兵; 王俊瑞

    2015-01-01

    目的:对比静脉滴注与关节腔内局部注射氨甲环酸对控制全膝关节置换术(TKA)失血量的有效性及手术安全性。方法将医院2012年1月至2014年10月收治的行全膝关节置换术患者73例随机分为静脉滴注组(对照组)40例和腔内使用组(治疗组)33例,其中静脉滴注组患者在麻醉诱导期使用氨甲环酸10 mg/kg,最大剂量1 g;腔内使用组患者术中关节囊缝合完成且止血带未放松前将氨甲环酸1g注入关节腔。结果腔内使用组术后总失血量较静脉滴注组明显减少( P<0.05),术后检测凝血功能(PT,APTT,INR)、深静脉血栓(DVT)发生率与静脉滴注组相比,差异有统计学意义( P ?0.05);结论关节腔内注射氨甲环酸是一种能有效控制全膝关节置换术后失血量且较安全的方案,不增加术后深静脉血栓发生概率。%Objective To compare the effects and operative safety of intravenous drip and intra-articular cavity local injection of tranexamic acid on controlling blood loss volume in total knee arthroplasty. Methods Totally 73 patients with total knee arthroplasty treated in the hospital from January 2012 to October 2014 were randomly divided into the intravenous drip group(IVTA,contorl group, 40 cases) and the intra-articular use group(IATA,treatment group,33 cases). The patients in the control group used intravenous tranexamic acid 10 mg/kg,with the maximum dose 1. 0 g during the anesthetic induction period,while the patients in the treatment group were intra-articularlly injected by tranexamic acid 1 g at the finishing of articular capsule suture and before relaxing the tourni-quet. Results The postoperative total blood loss volume in the control group was significantly decreased compared with that in the treatment group( P < 0. 05);there were no statistically significant differences in the postoperative coagulation function(PT,APTT,INR) and the incidence rate of deep

  2. 曼月乐联合氨甲环酸治疗子宫疤痕愈合不良所致月经过多的疗效观察%Efficiency of mirena combined with tranexamic acid in excessive menstruation caused by uterine scar poor healing

    Institute of Scientific and Technical Information of China (English)

    阮晓燕

    2016-01-01

    Objective:To investigate the effect of mirena combined with tranexamic acid in excessive menstruation caused by uterine scar poor healing. Method:90 patients with uterine scar poor healing and excessive menstruation were randomly divided into mirena group(A group,29 cases),tranexamic acid group(B group,32 cases)and mirena com﹣bined tranexamic acid group(C group,29 cases). The efficiency after treatment were recorded and compared. Results:the menstrual quantity of the C group after treatment 1,3,6,9,12 months were significantly less than A and B group,and hemoglobin were significantly higher than A and B group,the differences were statistically significant(P < 0. 05 ). There were no significant differences in menstrual cycle,menstrual period and serum FSH,LH and E2(P ﹥ 0. 05). The total ef﹣fective rate of C group was 89. 6% ,it was significantly higher than 65. 5% and 65. 6% of A and B groups,the differences were statistically significant(P < 0. 05 ). Conclusion:mirena combined with tranexamic acid in the treatment of uterine scar healing has good effect.%目的:探讨曼月乐联合氨甲环酸治疗子宫疤痕愈合不良所致月经过多的临床疗效。方法将90例子宫疤痕愈合不良所致月经过多患者随机分为3组,分别为曼月乐组(A 组29人)、氨甲环酸组(B 组32人)和曼月乐组联合氨甲环酸组(C 组29人)。比较各组用药后各组间疗效差异。结果治疗后各组月经过多均得到有效治疗,C 组治疗后1、3、6、9、12个月时月经量均较其它两组明显减少,血红蛋白则明显升高,差异均有统计学意义( P〈0.05)。三组之间月经周期、月经期和血清 FSH、LH、E2水平比较均无统计学意义(P ﹥0.05)。C 组的总有效率89.6%,明显高于 A 组的65.5%和 B 组的65.6%,差异均有统计学意义(P <0.05)。结论曼月乐联合氨甲环酸治疗子宫疤痕愈合不良所致月经过多有显著疗效。

  3. Gadolinium Complex of 1,4,7,10-Tetraazacyclododecane-N,N',N'',N'''-1,4,7-trisacetic Acid (DO3A) Conjugate of Tranexamates: A Quest for a Liver-specific Magnetic Resonance Imaging Contrast Agent

    Energy Technology Data Exchange (ETDEWEB)

    Nam, Kisoo; Jeong, Hyunjeong; Kim, Heekyung; Choi, Garam; Chang, Yongmin; Kim, Taejeong [Kyungpook National Univ., Daegu (Korea, Republic of); Suh, Kyungjin [Dongguk Univ., Kyungju (Korea, Republic of)

    2014-01-15

    The work is directed toward the synthesis of a series of DO3A conjugates of tranexamates (1c-e) and their Gd complexes (2c-e) for use as a liver-specific MRI CA. All these complexes show thermodynamic and kinetic stabilities comparable to those of structurally related clinical agents such as Dotarem. Their R{sub 1} relaxivities also compare well with those of commercial agent, ranging 3.68-4.84 mM{sup -1}s{sup -1}. In vivo MR images of mice with 2a-e reveal that only 2a exhibits liver-specificity. Although 2b and 2c show strong enhancement in liver, yet no bile-excretion is observed to be termed as a liver-specific agent. The rest behaves much like ordinary ECF CAs like Dotarem. The new series possess no toxicity to be employed in vivo.

  4. Application of tranexamic acid reduces blood less in unilateral total knee arthroplasty with different methods:a prospective comparison analysis%不同氨甲环酸给药途径对全膝关节置换术出血量影响的临床研究

    Institute of Scientific and Technical Information of China (English)

    及松洁; 周一新; 李玉军; 徐辉

    2015-01-01

    目的:探讨单侧全膝关节置换(TKA)术中应用氨甲环酸的不同给药方法对出血量的影响。方法对2013年6月至2014年5月符合标准的120例初次单侧TKA术患者进行研究。其中男33例,女97例;年龄31~81岁,平均(65±9)岁。将患者分为静脉使用氨甲环酸组(V组)、局部使用氨甲环酸组(T组)、冲洗液使用氨甲环酸组(I组)以及未使用氨甲环酸组(L组),每组30例。4组患者的年龄、性别、体质量指数、疾病诊断、手术时间、术前血红蛋白、术前红细胞比积等参数差异均无统计学意义(P>0.05)。记录术后失红细胞量和输红细胞量,观察患者是否出现下肢深静脉栓塞症状。组间比较采用单因素方差分析。结果V组总红细胞丢失量为(368±95)mL,T组(407±118)mL,少于对照组(509±96)mL,差异有统计学意义(P<0.05)。I组总红细胞丢失量为(491±122)mL,与C组比较差异无统计学意义(P=0.924)。V组隐性失血量最少,T组可见失血量最少。4组均未出现深静脉栓塞、感染等并发症。结论TKA术中静脉和局部使用氨甲环酸均能明显减少术后出血量。冲洗液中加入氨甲环酸不能有效减少出血量。%Objective To investigate the effect of the application of tranexamic acid in unilateral total knee arthroplasty (TKA)with different methods .Methods Totally 120 cases of primary unilateral TKA patients admitted from June 2013 to May 2012 were studied ,including 33 males and 97 females ,with the average age of (65 ± 9) years (31 to 81 years) .Patients were divided into intravenous tranexamic acid group (group V ) ,topical tranexamic acid group (group T ) and irrigation using tranexamic acid group (group I) ,and control group (group C) .There were 30 cases in each group .Four groups of patients had no differences in age ,gender ,body mass index and disease diagnosis ,operative time

  5. Intra-articular and intravenous injection of tranexamic acid effectively reduces blood loss after total knee arthroplasty%氨甲环酸关节腔给药联合静脉给药可有效减少全膝关节置换后出血

    Institute of Scientific and Technical Information of China (English)

    徐建; 哈承志; 田少奇; 王远贺; 刘宁宁; 孙康

    2016-01-01

    背景:有研究表明氨甲环酸能够有效减少全膝关节置换术患者的术后出血量,但是氨甲环酸的给药方式有多种,包括关节腔注射,静脉注射和两者联合用药,但效果尚无定论。  目的:探讨关节腔注射,静脉注射和两者联合用药3种氨甲环酸给药方式是否能够有效的减少全膝关节置换后出血。  方法:试验选择2014年12月到2015年12月进行单侧全膝关节置换术的患者103例,根据氨甲环酸的给药方式不同随机分为4组:关节腔注射组术中膝关节切口缝合后给予关节腔注射液2000 mg氨甲环酸;静脉注射组在止血带使用前15 min静脉注射1000 mg氨甲环酸;联合治疗组采用上述2种方法联合干预;空白对照组不采用氨甲环酸干预。  结果与结论:①总出血量和输血率:关节腔注射组和联合治疗组的总出血量和输血率均少于静脉给药组(P 0.05),两组输血率均为0%;②不良反应:各组中均未出现深静脉血栓、肺部血栓、切口感染、血肿和坏疽等不良反应;③结果证实:氨甲环酸关节腔给药联合静脉给药可有效减少全膝关节置换后出血,效果略优于单独给药。%BACKGROUND: Studies have shown that tranexamic acid can effectively reduce postoperative blood loss in patients with total knee arthroplasty. There are many means to inject tranexamic acid (intra-articular injection, intravenous injection and their combination). Which is the best way has no conclusion. OBJECTIVE: To explore whether all three ways (intra-articular injection, intravenous injection and their combination) to inject tranexamic acid can all effectively reduce the bleeding after total knee arthroplasty. METHODS:103 patients undergoing unilateral total knee arthroplasty from December 2014 to December 2015 were enrolled in this study. The patients were allocated into four groups according to injection way. In the intra

  6. Effect of tranexamic acid on perioperative hidden blood loss in aged patients receiving intramedullary fixation for treatment of intertrochanteric fractures%氨甲环酸对老年股骨转子间骨折髓内固定术围手术期隐性失血的影响

    Institute of Scientific and Technical Information of China (English)

    朱云森; 江敞; 李俊

    2015-01-01

    Objective:To explore the effect of tranexamic acid on perioperative hidden blood loss in aged patients receiving intramedul-lary fixation for treatment of intertrochanteric fractures.Methods:Eighty-three aged patients with intertrochanteric fractures enrolled in the study were randomly divided into tranexamic acid group(43 cases)and conventional group(40 cases).All patients were treated with proxi-mal femoral nail antirotation(PFNA)internal fixation by the same group of surgeons.Intravenous drip infusions of tranexamic acid(10 mg/kg) were performed on patients in tranexamic acid group on the day of admission and before the start of the surgery respectively.Then the blood loss were measured and compared between the 2 groups and the postoperative deep vein thrombosis were also recorded.Results:There was no statistical difference in operation time and dominant blood loss between the 2 groups(32.58 +/-5.12 vs 31.90 +/-8.73 min,t =0.437,P =0.110;89.67 +/-15.24 vs 97.60 +/-14.65 mL,t =2.410,P =0.794),while hidden blood loss was less in the tranexamic acid group compared to the conventional group before and after the operation(84.91 +/-13.66 vs 154.08 +/-26.99 mL,t =14.883,P =0.000;158.23 +/-30.16 vs 286.15 +/-59.61 mL,t =12.460,P =0.013).Deep venous thrombosis was not found in both of the 2 groups.Conclusion:Application of tranexamic acid can effectively reduce perioperative hidden blood loss in aged patients receiving intr-amedullary fixation for treatment of intertrochanteric fractures,meanwhile it has high safety.%目的:探讨氨甲环酸对老年股骨转子间骨折髓内固定术围手术期隐性失血的影响。方法:将83例符合要求的老年股骨转子间骨折患者随机分为2组,氨甲环酸组43例、常规组40例。所有患者的手术均由同一组医生完成,均采用股骨近端防旋髓内钉内固定治疗,氨甲环酸组患者分别于入院当天和手术开始前静脉滴注氨甲环酸(10 mg·kg -1)1次。测定2组患

  7. Different methods of tranexamic acid administration on reducing blood loss during total hip arthroplasty%不同时间给予氨甲环酸对减少全髋关节置换术中术后失血的影响

    Institute of Scientific and Technical Information of China (English)

    张朋; 陈勇忠; 杨良锁; 王剑火; 邹仪强; 黄哲

    2014-01-01

    目的:比较氨甲环酸不同给药时间对全髋关节置换( THA)术中及术后失血量的影响。方法选取行单侧THA的患者125例,随机分为5组,每组25例,A组手术结束前10 min给予1 g氨甲环酸静脉滴注;B组分别于手术结束前10 min、术后7 h给予1 g氨甲环酸静脉滴注;C组术前10 min给予1 g氨甲环酸静脉滴注;D组术前10 min给予1 g氨甲环酸,7 h后再给予1 g氨甲环酸静脉滴注;E组为对照组,不给于氨甲环酸及其类似药物。检测血红蛋白、红细胞压积、出血时间、活化部分凝血酶时间等血液学指标,比较5组患者术中及术后失血量差异。结果5组患者术中失血量、术后失血量、术后第1天血红蛋白下降值、围手术期最大血红蛋白减少值、术后绝对失血量差异均具有统计学意义(P<0.05)。 E组5项数值均显著高于其它各组(P<0.05)。 D组术中失血量、围手术期最大血红蛋白减少值、术后绝对失血量分别为(272.9±46.7)ml、(27.8±3.8)g/L、(344.4±61.6)ml,均显著少(小)于A组、B组及E组(P<0.05)。 C组术后失血量、术后第1天血红蛋白下降值,分别为(114.7±32.7)ml、(21.0±3.9)g/L,均显著少(小)于A组、B组及E组(P<0.05)。结论术前10 min给予1 g氨甲环酸,7 h后再给予1 g氨甲环酸静脉滴注在THA围手术期能够最大限度地减少术中及术后出血量。%Objective To compare the different timing of administration of tranexamic acid on total hip arthroplasty and postoperative blood loss. Methods 125 cases undergo total hip arthroplasty were randomly divided into five groups, 25 cases each. Patients in group A received 1g tranexamic acid intravenously 10min before the end of surger-y, group B received 1g tranexamic acid intravenously 10 min before the end of surgery and again in 7 hours after sur-gery, group C received 1g tranexamic acid intravenously 10 min before surgery, group D received 1g tranexamic acid 10 min before surgery and

  8. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    McAlindon, T. E.; Driban, J. B.; Henrotin, Y.;

    2015-01-01

    The goal of this document is to update the original OARSI recommendations specifically for the design, conduct, and reporting of clinical trials that target symptom or structure modification among individuals with knee osteoarthritis (OA). To develop recommendations for the design, conduct......, and reporting of clinical trials for knee OA we initially drafted recommendations through an iterative process. Members of the working group included representatives from industry and academia. After the working group members reviewed a final draft, they scored the appropriateness for recommendations. After...... and index knee, describing interventions, patient-reported and physical performance measures, structural outcome measures, biochemical biomarkers, and reporting recommendations. In summary, the working group identified 25 recommendations that represent the current best practices regarding clinical trials...

  9. 氨甲环酸对类风湿关节炎患者全髋关节置换围手术期失血的影响%The efficacy and safety of tranexamic acid on bleeding in rheumatoid arthritis patients following total hip arthroplasty:a retrospective study

    Institute of Scientific and Technical Information of China (English)

    谢锦伟; 岳辰; 裴福兴; 康鹏德

    2015-01-01

    Objective To investigate the efficacy and safety of tranexamic acid on bleeding in rheumatoid arthritis (RA) patients undergoing total hip arthroplasty (THA). Methods A retrospective study was performed in 197 RA patients (Steinbrock⁃er III-IV) following primary unilateral THA from June 2012 to June 2014. The patients were divided to three groups based on the regimen of tranexamic acid:68 patients received a single intravenous dosage of 15 mg/kg tranexamic acid 20 min prior to opera⁃tion (single dose group);74 patients received an intravenous dosage of 15 mg/kg preoperatively and a second dosage of 10 mg/kg 3 hours postoperatively (repeated dose group);the other 55 patients didn't receive tranexamic acid (control group). The primary out⁃comes were total blood loss, transfusion rate, the incidence of deep vein thrombosis (DVT) and pulmonary embolism (PE). The sec⁃ondary outcomes were postoperative drainage, hemoglobin (Hb) drop on third day postoperatively and other wound related compli⁃cations. Results There was less total blood loss (816.80 ± 245.09 ml vs 975.15 ± 216.33 ml vs 1 295.68 ± 263.85 ml), drainage (221.60 ± 70.05 ml vs 337.20 ± 113.10 ml vs 479.74 ± 120.66 ml), transfusion requirement (5.41%vs 10.29%vs 25.45%) and Hb drop (2.71±0.74 g/dl vs 3.18±0.62 g/dl vs 3.83±0.70 g/dl) in experimental group when compared with control group. And the effect was better in repeated dose group, with less total blood loss (816.80 ± 245.09 ml), less transfusion requirement (5.41%) and less postoperative drainage (221.60±70.05 ml). No episode of DVT or PE occurred in either group. There were 8 wound complications in single dose group, 6 in repeated group, and 8 in control group, and there were no statistically difference. Conclusion Intrave⁃nous administration of tranexamic acid was effective and safe on decreasing blood loss and transfusion requirement in RA patients following THA. Compared with a single dosage of tranexamic acid preoperatively, a

  10. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... care trials, researchers look for ways to make life better for people living with a life threatening disease or chronic health problem. The goal ... experimental treatment on a small group of often healthy people (20 to 80), to judge its safety ...

  11. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... to find out if an experimental drug, therapy, medical device, lifestyle change, or test will help treat, find, or prevent a disease. A clinical trial may compare experimental products or ... universities and medical centers across the country. The National Institutes of ...

  12. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... care trials, researchers look for ways to make life better for people living with a life threatening disease or chronic health problem. The goal ... to obtain preliminary data on whether the drug works in people who have a certain disease or ...

  13. The ONTARGET trial programme

    DEFF Research Database (Denmark)

    Unger, Thomas; Kintscher, Ulrich; Kappert, Kai;

    2009-01-01

    consisting of cardiovascular death, non-fatal stroke or myocardial infarction and hospitalisation for congestive heart failure. Patient selection and study procedures followed the previous HOPE trial. In the parallel TRANSCEND study, nearly 6.000 patients, all intolerant to ACE inhibition, were subjected...

  14. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    Emery, C. A.; Roos, Ewa M.; Verhagen, E.;

    2015-01-01

    The risk of post-traumatic osteoarthritis (PTOA) substantially increases following joint injury. Research efforts should focus on investigating the efficacy of preventative strategies in high quality randomized controlled trials (RCT). The objective of these OARSI RCT recommendations is to inform...

  15. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... are usually described based on their phase. The U.S. Food and Drug Administration typically requires Phase 1, ... hundred to about 3,000 people. If the U.S. Food and Drug Administration agrees that the trial ...

  16. Hepatitis C: Clinical Trials

    Science.gov (United States)

    ... Reports Clinician Tools Clinician Tools Home Guidelines and Best Practices Topic Reviews Algorithms, Screens, Toolkits Provider Education Provider ... about federally and privately supported clinical research in human volunteers. Site gives information about a trial's purpose, who may participate, locations, and phone ... Forms State and Local Resources Strat Plan FY 2014-2020 VA Plans, Budget, & ...

  17. Randomised clinical trial

    DEFF Research Database (Denmark)

    Reimer, C; Lødrup, A B; Smith, G;

    2016-01-01

    of an alginate (Gaviscon Advance, Reckitt Benckiser, Slough, UK) on reflux symptoms in patients with persistent symptoms despite once daily PPI. METHODS: This was a multicentre, randomised, placebo-controlled, 7-day double-blind trial preceded by a 7-day run-in period. Reflux symptoms were assessed using...

  18. The FOCUS trial

    DEFF Research Database (Denmark)

    Glenthøj, Louise B; Fagerlund, Birgitte; Randers, Lasse;

    2015-01-01

    trial enrolling 126 patients meeting the standardised criteria of being at UHR for psychosis. Patients are recruited from psychiatric in- and outpatient facilities in the Copenhagen catchment area. Patients are randomised to one of the two treatment arms: cognitive remediation plus standard treatment...

  19. HIV/AIDS Clinical Trials

    Science.gov (United States)

    ... Home Apps APIs Widgets Order Publications Skip Nav HIV/AIDS Clinical Trials Home > Clinical Trials Español small ... Renal (Kidney) Complications/Damage Skin Diseases FDA-Approved HIV Drugs Abacavir Atazanavir Atripla Cobicistat Combivir Complera Darunavir ...

  20. 磷酸肌酸钠复合氨甲环酸对非体外循环冠状动脉旁路移植术患者心肌和血液保护作用的研究%The myocardial and blood protectivie effects of creatine phosphate sodium combined with tranexamic acid in off-pump coronary artery bypass grafting

    Institute of Scientific and Technical Information of China (English)

    李长营; 郭爱华; 张宗旺; 张学俊; 张雷; 敖虎山

    2011-01-01

    Objective To investigate whether the supplement of creatine phosphate sodium and tranexamic acid to cardioplegic solutions can improve myocardial protection and blood conservation in off-pump coronary artery bypass graft(OPCABG).Methods 280 patients undergoing OPCABG were randomly assigned to experimental group (CP with TA group, n=70 ) , creatine phosphate sodium group (CP group, n=70), tranexamic acid group (TA group, n=70) and control group (n=70). Before BACG,creatine phosphate sodium ( 100 mg/kg) combined with tranexamic acid (30 mg/kg), creatine phosphate sodium ( 100 mg/kg),tranexamic acid (30 mg/kg), and equal volume of normal saline were given intravenously in each group respectively. Venous blood samples were taken preoperatively, and at 0, 6, 12, 24, 48, 72 h, 7 d postoperatively to analyze creatine kinase isoenzyme (CK-MB), troponin (cTnI) ; Meanwhile, the amount of cumulative chest fluid drainage and inotropic agent and blood transfused were also recorded. Results The plasma concentrations of CK-MB in experimental group at 6, 12, 24, 48, 72 h postoperatively (15±6), (14±5), (16±10), (15±6) and (13±6) U/ml and the plasma concentrations of cTnI(235±1.53), (2.72±1.46), (2.64±1.32),(1.16±0.76) and (0.48±0.24) mg/L were significantly lower than those in group CP, group TA and control group (P<0.05). The amount of postoperative cumulative chest fluid at 6, 12, 24, 48, 72 h were (246±56), (420±82), (680±114), (725±126) and (730±130) ml drainage and blood transfuison in experimental group (5/70) were also significantly lower than those in other groups (P<0.05). Conclusion For patients undergoing OPCABG, creatine phosphate sodium combined with tranexamic acid plays an important role in myocardial protection and blood conservation without increasing the surgical mortality and the incidence of postoperative complications.%目的 研究在非体外循环下行冠状动脉旁路移植术(off-pump coronary artery bypass grafting,OPCABG)中应用

  1. Study on the Protective Effect of Tranexamic Acid Evaluated by Thromboelastography in Cardiopulmonary Bypass%血栓弹力图评价氨甲环酸在体外循环中的血液保护效果的研究

    Institute of Scientific and Technical Information of China (English)

    丰巨龙; 吴海军; 姜文斌; 李征; 张杰; 程显峰

    2015-01-01

    [ ABSTRACT] Objective To evaluate the protective effect of tranexamic acid in valve replacement patients through thromboelastog-raphy on coagulation function of statistical evaluation,and further to determine the optimal dosage of tranexamic acid in cardiopulmonary by-pass.Methods One hundred cases of valve replacement patients were randomly divided into four groups:A,B,C,D groups.Group B,group C and group D were respectively treated with ammonia tranexamic acid powder( load Mo plug) and the dose is 20mg/kg,40mg/kg,60mg/kg (diluted to 50ml to join in the perfusion solution),each half of the total amount was given in priming solution during rewarming of cardiopul-monary Bypass.Group A was given 50ml normal saline at the corresponding time points,recording the activated clotting time( ACT) before, during and after CPB;before transfer(T1),heparin and after(T2),heparin and after 3h(T3),TEG examination were performed in the inter-nal jugular vein.Results There was no significant difference about the results of TEG among the four groups before CPB(T1).After neutral-ization(T2),there was no significant difference among the 4 groups.While in heparin and 3h(T3),compared to group A,the values of group B,C,D were significantly different,R values and K values were significantly lower than those in group A,MA and a values were significantly increased compared with A.But there were no significant difference among B,C,D three groups;The results of coagulation function tests be-fore and after CPB were compared and analysed,and the results showed that the two time points after CPB were significantly different.Com-pared to the preoperative,the value R and K were significantly prolonged,and the value MA and a were significantly decreased.Conclusion The application of tranexamic acid contribute to the protection of the coagulation system during cardiopulmonary bypas in heart valve replace-ment surgery,either to platelet or to coagulation factor fiber protein.20mg/kg,40 mg/kg,60mg

  2. 静脉联合局部应用氨甲环酸对单侧全膝关节置换围术期出血量影响及安全性评估%Effect of Intravenous and Topical Application of Tranexamic Acid on Bleeding Amount in the Perioperative Period of Unilateral Total Knee Replacement and its Safety Evaluation

    Institute of Scientific and Technical Information of China (English)

    赵良虎; 刘典锋; 黄金; 刘汉涛

    2015-01-01

    目的:观察静脉联合局部应用氨甲环酸对单侧全膝关节置换术术中、术后出血量、输血量、血红蛋白值及凝血功能的影响并对其安全性加以评估。方法:将86例初次行单侧全膝关节置换术的患者随机分为治疗组和对照组,每组43例。治疗组在假体安装完成缝合开始时,给1 g氨甲环酸配入100 mL生理盐水静脉滴注;膝关节假体安装完缝合关节囊后,再给1 g氨甲环酸稀释于50 mL生理盐水注入关节腔内;术后3h再次静脉滴入1g氨甲环酸。对照组给予等量生理盐水静脉滴注。比较两组术中出血量、术后可见失血量、输血量、输血人数及术后血红蛋白值、术后纤维蛋白原、凝血酶原时间等检测结果;术后观察患者是否出现下肢深静脉栓塞的临床症状,术后1周行常规下肢深静脉多普勒超声检查。结果:两组术中失血量比较,差异无统计学意义(P >0.05),但术后失血量、输血量、输血人数比较,治疗组均明显低于对照组(P 0.05);术后1周下肢深静脉血栓形成率比较,差异无统计学意义(P >0.05)。结论:局部及联合静脉应用氨甲环酸在全膝关节置换术中及术后,能明显降低患者的术后失血量及输血量等,具有良好的止血效果且不增加静脉血栓形成的风险。%[ABSTRACT]Objective:To explore the effect of intravenous and topical application of tranexamic acid on amount of bleeding and blood transfusion,content of hemoglobin and blood coagulation in the perioperative period of unilateral total knee replacement and its safety evaluation.Methods:86 patients who would undergo unilateral total knee replacement were randomly divided into a treatment group and a control group,43 cases in each.Patients of the treatment group were given intravenous drip of tranexamic acid(1 g) and physiological saline(100 mL) while stitching after prosthesis installation and given

  3. Influence of the application timing in tranexamic acid therapy on the blood loss of patients with total hip arthroplasty%氨甲环酸应用时机对髋关节置换手术患者失血量影响的研究

    Institute of Scientific and Technical Information of China (English)

    甘伟伟; 刘斌; 谢贵杰

    2014-01-01

    Objective To discuss the impact of the application timing in tranexamic acid therapy on the blood loss of patients with pre-liminary total hip arthroplasty.Methods Ninety patients with preliminary total hip arthroplasty were assigned into early stage group (n=30,tranexamic acid at preoperative one hour),advanced stage group (n=30,tranexamic acid in operation),and control group (n=30,without tranexamic acid).The visible red blood cell loss,hidden red blood cell loss,and total red blood cell loss were analyzed.Re-sults (1)The visible red blood cell loss in control group (96.3 ±21.7)mL was significantly more than early stage group (45.9 ± 9.7)mL and advanced stage group (46.2 ±9.5)mL,Ps0.05).(2)The hidden red blood cell loss in early stage group (140.6 ±21.1)mL and advanced stage group (216.7 ±48.6)mL were significantly lower than control group (335.1 ±60.3)mL,Ps<0.01.Moreover,hidden red blood cell loss in early stage group was significantly lower than advanced stage group (P<0.01).(3)The total red blood cell loss in early stage group (236.7 ±42.4)mL and advanced stage group (344.0 ±51.5)mL were significantly lower than control group (492.8 ±65.1) mL,Ps<0.01.The total red blood cell loss in early stage group was significantly lower than advanced stage group (P<0.01).Conclu-sions Tranexamic acid reduces the blood loss in preliminary total hip arthroplasty,especially reducing hidden blood loss when used at preoperative one hour.%目的:探讨不同时间使用氨甲环酸对初次行髋关节置换术患者失血量的影响。方法将90例初次行髋关节置换术的患者按随机数字表法分为:早期组(30例,氨甲环酸术前1 h使用)、晚期组(30例,氨甲环酸术中使用)和对照组(30例,不使用)。统计分析患者的显性红细胞丢失量、隐性红细胞丢失量与总红细胞丢失量。结果(1)对照组(96.3±21.7)mL的显性失血量显著多于早期组(45.9±9.7)mL、晚期组(46

  4. 静脉应用不同剂量氨甲环酸对全膝关节置换围手术期失血的影响%The Intravenous Application of Different Doses of Tranexamic Acid on Total Knee Replacement ;Effect of Perioperative Blood Loss

    Institute of Scientific and Technical Information of China (English)

    潘云春; 刘琳娜; 张其亮

    2016-01-01

    Objective:To evaluate the intravenous injection of different dose of tranexamic acid on primary unilateral total knee arthroplasty peri operative blood loss quantity and safety influence.Method:From September 2012 to January 2014,250 cases of primary unilateral total knee arthroplasty in our hospital were selected as the research objects,they were randomly divided into the control group,tranexamic acid 10 mg/kg group,15 mg/kg group,20 mg/kg group and 30 mg/kg group,each group had 50 cases.Application of tranexamic acid of the four groups respectively at 30 min before tourniquet release the tranexamic acid in accordance with 10,15,20,30 mg/kg diluted in normal saline 100 mL by intravenous drip.Five groups began drainage in postoperative closed tube 2 h and drew tube postoperative 48 h.After 1,3,7 days hemoglobin content and hematocrit,most postoperative hemoglobin loss,total drainage volume and total blood loss,hidden blood loss, blood transfusion rate,postoperative venous thrombosis of the lower limbs occurred rate and other complications of five groups were recorded and compared.Result:The hemoglobin content and hematocrit of 1,3 and 7 d after operation among five groups were compared,there was no significant difference between the 20 mg/kg group and 30 mg/kg group(P>0.05),and there were significant differences between the other groups(P0.05).Venous thromboembolism(VTE), infection,renal failure and other complications were not found in the five groups.Conclusion:Intravenous application of 10,15,20 and 30 mg/kg dose of tranexamic acid can effectively reduce the blood loss and blood transfusion rates of the patients undergoing total knee arthroplasty,and will not increase the risk of perioperative venous thrombosis.To reduce bleeding,blood transfusion rate and possible risk analysis,20 mg/kg dose was the best dose.%目的:探讨静脉注射不同剂量氨甲环酸对初次单侧人工全膝关节置换围手术期失血量及安全

  5. 冷冻氨甲环酸注射液对全膝关节表面置换术后失血量的影响%Effect of frozen tranexamic acid injection on the blood loss after total knee arthroplasty

    Institute of Scientific and Technical Information of China (English)

    马涛; 朱云; 李毓灵; 杨刚; 王正宇; 张健

    2015-01-01

    目的:探讨全膝关节表面置换术(total knee arthroplasty,TKA)后关节腔内灌注冷冻氨甲环酸注射液对术后失血量的影响.方法:健康成年新西兰大白兔(雌雄未分)45只,按照随机分组的方法分为3组,建立TKA模型,术毕关节腔内留置引流管,逐层缝合切口,通过引流管向兔膝关节腔内分别注入A组:冷冻生理盐水注射液3 ml(0℃);B组:常温氨甲环注射液3ml(30 mg/ml);C组:冷冻氨甲环酸注射液3 ml(30 mg/ml,0℃).术后引流管夹闭4h后开放行持续负压引流,术后24h拔除引流管,记录各实验对象术后切口的引流量及术后第3d血红蛋白(hemoglobin,Hb)的下降幅度.结果:术后24 h,3组实验对象切口引流量分别为A组(9.61±1.31) ml,B组(6.37±1.25) ml,C组(4.13±0.88) ml,C组术后平均引流量明显少于A组(P=0.000)和B组P=0.000)术后的切口引流量;术后第3d3组实验对象的Hb下降幅度分别为A组(22.80±3.23) g/L,B组(17.73±4.16) g/L,C组(13.80±3.82) g/L,C组术后第3天的Hb下降幅度明显低于A组(P=0.000)和B组(P=0.006)的Hb下降幅度.结论:兔膝TKA术后关节腔内灌注冷冻氨甲环酸注射液较常温氨甲环酸注射液相比,更能够有效减少术后引流量和术后Hb的下降幅度.%Objective:To study the effects of using frozen tranexamic acid for intra-articular injection on blood loss after total knee arthroplasty(TKA).Methods:Totally 45 New Zealand white rabbits unsexed were randomly divided into 3 groups to build the TKA operation model.After operation,a drainage tube was placed in the articular cavity,then the incision was sutured.Different solutions were injected in articular cavity in 3 groups by drainage tubes:in group A,normal ice normal saline 3 ml(0 ℃);in group B,normal temperature tranexamic acid 3 ml (concentration of 30 mg/ml);in group C:frozen tranexamic acid 3 ml(concentration of 30 mg/ml,0 ℃).The drainage tube was clamped for 4 h,then opened to keep continuous vacuum aspiration

  6. Influence of Different Tranexamic Acid Administration Methods during and after Cardiac Surgery on Coagulation Function and Postoperative Blood Loss%氨甲环酸不同给药方式对心脏手术患者凝血功能及出血量的影响

    Institute of Scientific and Technical Information of China (English)

    王静捷; 陈广俊; 刘薇; 黄宇光; 罗爱伦; 苗齐

    2013-01-01

    Objective To evaluate the influence of different tranexamic acid administration methods during and after cardiac surgery with cardiopulmonary bypass (CPB ) on coagulation function and postoperative bleeding. Methods Patients undergoing elective cardiac surgery with use of CPB (n = 60 ) were randomized in a double-blind fashion to one of two treatment groups: group A (n = 30 ) , administered with tranexamic acid 10 mg/kg (intravenous injection slowly before skin incision) , followed by infusion of normal saline until postoperative 12 hours; and group B (n =30) , administered with tranexamic acid 10 mg/kg (intravenous injection slowly before skin incision) , followed by infusion of tranexamic acid 1 mg/(kg · h) until postoperative 12 hours. Hemoglobin, platelet count, and coagulation function were assessed before anesthesia induction, after surgery, 8am next day and 24 hours after surgery. Bleeding, allogeneic blood transfusion, and fluid infusion during the postoperative 24 hours were recorded. Result No differences were found between groups in terms of coagulant function, postoperative bleeding, allogeneic blood transfusion, and fluid infusion ( P > 0. 05 ) . Conclusion Compared with intraoperative administration alone, prolonged treatment with tranexamic acid after cardiac surgery shows no advantage because it can not further improve coagulant function, reduce bleeding, or reduce allogeneic blood transfusion.%目的 观察氨甲环酸不同给药方式对体外循环(CPB)心脏手术患者凝血功能及出血量的影响.方法 选择择期CPB心脏手术患者60例,随机分为氨甲环酸+生理盐水组(氨甲环酸10 mg/kg切皮前缓慢静脉推注;随后持续输注生理盐水至术后12 h,n=30)和氨甲环酸+氨甲环酸组[氨甲环酸10 mg/kg切皮前缓慢静脉推注;随后1 mg/(kg·h)持续输注氨甲环酸至术后12 h,n=30].在麻醉诱导前、手术结束时、次日晨8:00和术后24 h 4个时间点取血测定血常规和凝血功能.记录

  7. The Trial of Katherine Harrison.

    Science.gov (United States)

    Woodward, Walter W.

    2003-01-01

    Presents a lesson plan in which the teacher and students participate in a mock trial of Katherine Harrison, who was accused of witchcraft in the seventeenth century. Provides background information about the trial, as well as primary sources of the testimonies given by witnesses during the trial. (CMK)

  8. Registration of randomized clinical trials

    DEFF Research Database (Denmark)

    Østervig, R M; Sonne, A; Rasmussen, L S

    2015-01-01

    starting enrolment before 2010 to 63.2% after 2010 (24/38, P clinical trials were registered at clinicaltrials.gov. CONCLUSION: Many published randomized controlled trials from Acta Anaesthesiologica Scandinavica were not adequately registered but the requirement of trial registration has...

  9. The COLOFOL trial

    DEFF Research Database (Denmark)

    Hansdotter Andersson, Pernilla; Wille-Jørgensen, Peer; Horváth-Puhó, Erzsébet;

    2016-01-01

    in tumor location and stage distribution, with 5.6% more patients in the randomized group having colon cancer and 6.7% more patients having stage II disease. CONCLUSION: Patients in the two study arms were not only demographically similar, but also similar to nonincluded eligible patients, apart from stage......INTRODUCTION: The COLOFOL trial, a prospective randomized multicenter trial comparing two follow-up regimes after curative surgical treatment for colorectal cancer, focuses on detection of asymptomatic recurrences. This paper aims to describe the design and recruitment procedure in the COLOFOL...... population. To be eligible, patients had to be 75 years or younger and curatively resected for stage II or III colorectal cancer. Exclusion criteria were hereditary colorectal cancer, no signed consent, other malignancy, and life expectancy less than 2 years due to concomitant disease. In four of the 24...

  10. a randomized, controlled trial

    OpenAIRE

    Reinecke, Franziska

    2010-01-01

    The polycystic ovarian syndrome (PCOS) is characterized by hyperandrogenism and associated with obesity and impaired glucose metabolism. Despite the high prevalence of PCOS and the considerable clinical impact, the precise interplay between metabolism and hyperandrogenemia is not entirely clear. To analyse the effects of intravenous lipid and heparin infusion on circulating androgen levels in healthy women, we performed a randomized controlled cross-over trial. 12 healthy young women durin...

  11. Randomised clinical trial

    DEFF Research Database (Denmark)

    Meineche-Schmidt, V.; Christensen, E.; Bytzer, P.

    2011-01-01

    Background: Response to proton pump inhibitor (PPI) treatment in dyspepsia is unpredictable. Aim: To identify symptoms associated with response to esomeprazole in order to target patients for empirical treatment. Methods: Eight hundred and five uninvestigated, primary care patients with upper GI ....... Conclusions In patients with uninvestigated dyspepsia, PPI responders can be reliably identified by a simple pocket chart using symptoms and patient characteristics (ClinicalTrials.gov NCT00318968). © 2010 Blackwell Publishing Ltd....

  12. NATO SOCMET trials

    Science.gov (United States)

    Jenden, C. M.

    1993-11-01

    During 1993, Canada, France, Germany and the United Kingdom will be participating in the Smoke and Obscurants Countermeasures Materials Evaluation Tests (SOCMET). The tests will be carried out under the auspices of the NATO Army Armaments Group, AC/225, Panel VI, Sub-Panel 7 whose interests include multispectral smoke screening systems. The tests will comprise two sets of trials; one under cold climate conditions in Quebec, Canada, during February/March 1993 and the other in temperate conditions in Bourges, France during September 1993. This paper provides an insight into the management and aims of SOCMET. The evaluations will be seeking to identify candidate materials which create effective obscurant screens in the visible, infrared and millimetric bands of the electromagnetic spectrum. These materials will be disseminated through a range area dispersal. A key element of the trials will be the evaluation of field test instrumentation which may eventually lead to the development of standardized evaluation techniques. Following the trials, a scientific workshop will be held to review the results. A final report will be presented to NATO which will form the basis of future collaborative developments on multispectral screening systems leading towards standard NATO documentation on smoke and obscurant systems.

  13. 关节内注射氨甲环酸减少全膝关节置换术后失血的临床分析%Clinical study on intra-articular injection of tranexamic acid to reduce blood loss in total knee replacement

    Institute of Scientific and Technical Information of China (English)

    彭伟

    2014-01-01

    目的:探讨关节内注射氨甲环酸对人工全膝关节置换术后失血的影响。方法将50例采取单侧初次人工全膝关节置换患者,随机分为治疗组25例和对照组25例。治疗组采用关节腔内注射氨甲环酸1000 mg,术后夹闭引流2 h,对照组采用生理盐水。术后记录术中失血量、术后引流量、血红蛋白( Hb)、红细胞压积( Hct)和输血例数、D-二聚体改变以及深静脉血栓发生例数。结果治疗组术后引流量、输血例数和D-二聚体值显著低于对照组(P<0.05);治疗组血红蛋白、红细胞压积显著高于对照组(P<0.05);2组均无深静脉血栓形成。结论人工全膝关节置换术后关节腔内注射氨甲环酸并夹闭引流2 h的方法能够有效减少术后失血量,同时不增加深静脉血栓发生率。%Objective To examine the influence of inra-articular injection of tranexamic acid on blood loss after total knee replacement. Methods 50 patients with unilateral primary total knee replacement were enrolled and they were randomly divided into two groups:the stud-y group (n=25 cases),which were given intra-articular injection of tranexamic acid (1 000 mg) and drain clamping for 2 hour posteratively, and the control group ( n=25 cases) ,which were given physiologic saline. The blood loss,postoperative volume of drainage,hemoglobin lev-el,hematocrit,blood transfusion cases,D-dimer level and deep venous tromboemblic ( DVT) events were recorded. Results Postoperative volume of drainage,blood transfusion cases and D-dimer level were lower in the study group (P<0. 05). Hemoglobin level and hematocrit were higher in the study group (P<0. 05). No DVT ocurred in the two groups. Conclusion Intra-articular injection of tranexamic acid with 2 hours of drain-clamping is effective for reducing postoperative blood loss in total knee replacement, and there is noincrease of deep venous tromboemblic.

  14. Blood Conservative Effects of Tranexamic Acid on Children with Cyanotic Congenital Heart Disease%氨甲环酸对发绀型先天性心脏病患儿的血液保护效果

    Institute of Scientific and Technical Information of China (English)

    涂杰; 张炳东; 吕静; 梁东科; 李涛

    2011-01-01

    Objective To study the blood conservative effects of tranexamic acid (TAX) on children with cyanotic congenital heart disease under cardiopulmonary bypass (CPB). Methods Sixty children aged 2-12 years old with cyanotic congenital heart disease and low saturation of blood oxygen ( 0.05). The plasma concentration of FIB was significantly higher while the D - D was significantly lower ( P 0.05) ,the platelet count and aggregation were significantly higher (P. < 0.01) at T4 in TAX group than those in control group. The total drainage and transfusion of blood products were significantly lower in TAX group than those in control group(P, <0.01). Conclusions TAX is effective in inhibiting fibrinolysis and protecting platelet function as well as reducing postoperative bleeding and blood transfusions in children with cyanotic congenital heart disease under cardiopulmonary bypass.%目的 探讨氨甲环酸(TAX)在体外循环(CPB)中对发绀型先天性心脏病(先心病)患儿的血液保护效果.方法 选择经皮血氧饱和度[Sp(02)]<80%的2~12岁的发绀型先心病患儿60例,随机分为TAX组和对照组,每组30例.TAX组在麻醉诱导后给予TAX 10 mg·kg-1,CPB预充液中加入10 mg·kg-1 TAX,鱼精蛋白中和肝素后再追加10 mg·kg-1TAX.对照组给予等量9 g·L-1盐水.于麻醉诱导前(基础状态,T1)、鱼精蛋白中和肝素后10 min(T2)、术后12 h(T3)、术后24 h(T4)分别测定血浆凝血酶原时间(PT)、活化部分凝血激酶时间(APTT)、纤维蛋白原(FIB)、D-二聚体(D-D)、血小板计数和血小板聚集功能;记录术后12 h、24h每公斤体质量纵隔心包引流量和成分输血量.结果 TAX组各指标在麻醉诱导前与对照组比较无统计学差异(Pa>0.05).在T2、T3时,TAX组与对照组比较PT、APTT无统计学差异(P>0.05),FIB明显升高(P<0.01),D-D明显降低(P<0.01),血小板计数和聚集功能明显升高(P<0.01).在L时TAX组PT、APTT、FIB和D-D与对照组

  15. Gateways to clinical trials.

    Science.gov (United States)

    Bayés, M; Rabasseda, X; Prous, J R

    2005-04-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity. prous.com. This issue focuses on the following selection of drugs: ABX-IL-8, Acclaim, adalimumab, AGI-1067, alagebrium chloride, alemtuzumab, Alequel, Androgel, anti-IL-12 MAb, AOD-9604, aripiprazole, atomoxetine hydrochloride; Biphasic insulin aspart, bosentan, botulinum toxin type B, bovine lactoferrin, brivudine; Cantuzumab mertansine, CB-1954, CDB-4124, CEA-TRICOM, choriogonadotropin alfa, cilansetron, CpG-10101, CpG-7909, CTL-102, CTL-102/CB-1954; DAC:GRF, darbepoetin alfa, davanat-1, decitabine, del-1 Genemedicine, dexanabinol, dextofisopam, dnaJP1, dronedarone hydrochloride, dutasteride; Ecogramostim, eletriptan, emtricitabine, EPI-hNE-4, eplerenone, eplivanserin fumarate, erlotinib hydrochloride, ertapenem sodium, escitalopram oxalate, esomeprazole magnesium, etoricoxib, ezetimibe; Falecalcitriol, fingolimod hydrochloride; Gepirone hydrochloride; HBV-ISS, HSV-2 theracine, human insulin; Imatinib mesylate, Indiplon, insulin glargine, ISAtx-247; L612 HuMAb, levodopa/carbidopa/entacapone, lidocaine/prilocaine, LL-2113AD, lucinactant, LY-156735; Meclinertant, metelimumab, morphine hydrochloride, morphine-6-glucuronide; Natalizumab, nimotuzumab, NX-1207, NYVAC-HIV C; Omalizumab, onercept, osanetant; PABA, palosuran sulfate, parathyroid hormone (human recombinant), parecoxib sodium, PBI-1402, PCK-3145, peginterferon alfa-2a, peginterferon alfa-2b, peginterferon alfa-2b/ribavirin, pemetrexed disodium, pimecrolimus, PINC, pregabalin; Ramelteon, rasagiline mesilate, rasburicase, rimonabant hydrochloride, RO-0098557, rofecoxib, rosiglitazone maleate/metformin hydrochloride; Safinamide mesilate, SHL-749, sitaxsentan sodium, sparfosic acid, SprayGel, squalamine, St. John's Wort

  16. Gateways to clinical trials.

    Science.gov (United States)

    Tomillero, A; Moral, M A

    2009-09-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: AAV1/SERCA2a, Abacavir sulfate/lamivudine, Adalimumab, Aliskiren fumarate, Ambrisentan, Aripiprazole, AT-7519, Atazanavir sulfate, Atomoxetine hydrochloride, Azacitidine, Azelnidipine; Besifloxacin hydrochloride, Bevacizumab, Bioabsorbable everolimus-eluting coronary stent, Bortezomib, Bosentan, Budesonide/formoterol fumarate; CAIV-T, Carisbamate, Casopitant mesylate, Certolizumab pegol, Cetuximab, Ciclesonide, Ciprofloxacin/dexamethasone, CTCE-9908; Dalcetrapib, Darunavir, Deferasirox, Desloratadine, Disitertide, Drotrecogin alfa (activated), DTA-H19, Duloxetine hydrochloride, Dutasteride; Ecogramostim, Efalizumab, Emtricitabine, Eribulin mesilate, Escitalopram oxalate, Eszopiclone, EUR-1008, Everolimus-eluting coronary stent, Exenatide; Fampridine, Fluticasone furoate, Formoterol fumarate/fluticasone propionate, Fosamprenavir calcium, Fulvestrant; Gabapentin enacarbil, GS-7904L; HPV-6/11/16/18, Human Secretin, Hydralazine hydrochloride/isosorbide dinitrate; Imatinib mesylate, Imexon, Inalimarev/Falimarev, Indacaterol, Indacaterol maleate, Inhalable human insulin, Insulin detemir, Insulin glargine, Ixabepilone; L-Alanosine, Lapatinib ditosylate, Lenalidomide, Levocetirizine dihydrochloride, Liraglutide, Lisdexamfetamine mesilate, Lopinavir, Loratadine/montelukast sodium, Lutropin alfa; MeNZB, Mepolizumab, Micafungin sodium, Morphine hydrochloride; Nabiximols, Nikkomycin Z; Olmesartan medoxomil, Omalizumab; Paclitaxel-eluting stent, Pegfilgrastim, Peginterferon alfa-2a, Peginterferon alfa-2b, Perifosine, PF-489791, Plitidepsin, Posaconazole, Pregabalin; QAX-576; Raltegravir potassium, Ramelteon, Rasagiline

  17. Gateways to clinical trials.

    Science.gov (United States)

    Tomillero, A; Moral, M A

    2010-11-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Thomson Reuters Integrity(SM), the drug discovery and development portal, http://www.thomsonreutersintegrity.com. This issue focuses on the following selection of drugs: Abatacept, Adalimumab, AdCD40L, Adefovir, Aleglitazar, Aliskiren fumarate, AM-103, Aminolevulinic acid methyl ester, Amlodipine, Anakinra, Aprepitant, Aripiprazole, Atazanavir sulfate, Axitinib; Belimumab, Bevacizumab, Bimatoprost, Bortezomib, Bupropion/naltrexone; Calcipotriol/betamethasone dipropionate, Certolizumab pegol, Ciclesonide, CYT-997; Darbepoetin alfa, Darunavir, Dasatinib, Desvenlafaxine succinate, Dexmethylphenidate hydrochloride cogramostim; Eltrombopag olamine, Emtricitabine, Escitalopram oxalate, Eslicarbazepine acetate, Eszopiclone, Etravirine, Everolimus-eluting coronary stent, Exenatide, Ezetimibe; Fenretinide, Filibuvir, Fludarabine; Golimumab; Hepatitis B hyperimmunoglobulin, HEV-239, HP-802-247, HPV-16/18 AS04, HPV-6/11/16/18, Human albumin, Human gammaglobulin; Imatinib mesylate, Inotuzumab ozogamicin, Invaplex 50 vaccine; Lapatinib ditosylate, Lenalidomide, Liposomal doxorubicin, Lopinavir, Lumiliximab, LY-686017; Maraviroc, Mecasermin rinfabate; Narlaprevir; Ocrelizumab, Oral insulin, Oritavancin, Oxycodone hydrochloride/naloxone; Paclitaxel-eluting stent, Palonosetron hydrochloride, PAN-811, Paroxetine, Pazopanib hydrochloride, Peginterferon alfa-2a, Peginterferon alfa-2b, Pemetrexed disodium, Pertuzumab, Pitavastatin calcium, Posaconazole, Pregabalin, Prucalopride succinate; Raltegravir potassium, Ranibizumab, RHAMM R3 peptide, Rosuvastatin calcium; Salclobuzic acid sodium salt, SCY-635, Selenate sodium, Semapimod hydrochloride, Silodosin, Siltuximab, Silybin, Sirolimus-eluting stent, SIR-Spheres, Sunitinib malate; Tapentadol hydrochloride, Tenofovir disoproxil

  18. Gateways to clinical trials.

    Science.gov (United States)

    Tomillero, A; Moral, M A

    2008-10-01

    Gateways to clinical trials is a guide to the most recent trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity(R), the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: (+)-Dapoxetine hydrochloride, (S)-Tenatoprazole sodium salt monohydrate 19-28z, Acotiamide hydrochloride hydrate, ADV-TK, AE-37, Aflibercept, Albinterferon alfa-2b, Aliskiren fumarate, Asenapine maleate, Axitinib; Bavituximab, Becatecarin, beta-1,3/1,6-Glucan, Bevacizumab, Bremelanotide; Calcipotriol/betamethasone dipropionate, Casopitant mesylate, Catumaxomab, CDX-110, Cediranib, CMD-193, Cositecan; Darinaparsin, Denosumab, DP-b99, Duloxetine hydrochloride; E75, Ecogramostim, Elacytarabine, EMD-273063, EndoTAG-1, Enzastaurin hydrochloride, Eplerenone, Eribulin mesilate, Esomeprazole magnesium, Etravirine, Everolimus, Ezetimibe; Faropenem daloxate, Febuxostat, Fenretinide; Ghrelin (human); I-131 ch-TNT-1/B, I-131-3F8, Iclaprim, Iguratimod, Iloperidone, Imatinib mesylate, Inalimarev/Falimarev, Indacaterol, Ipilimumab, Iratumumab, Ispinesib mesylate, Ixabepilone; Lapatinib ditosylate, Laquinimod sodium, Larotaxel dehydrate, Linezolid, LOR-2040; Mapatumumab, MKC-1, Motesanib diphosphate, Mycophenolic acid sodium salt; NK-012; Olanzapine pamoate, Oncolytic HSV, Ortataxel; Paclitaxel nanoparticles, Paclitaxel poliglumex, Paliperidone palmitate, Panitumumab, Patupilone, PCV-9, Pegfilgrastim, Peginterferon alfa-2a, Peginterferon alfa-2b, Pertuzumab, Picoplatin, Pimavanserin tartrate, Pimecrolimus, Plerixafor hydrochloride, PM-02734, Poly I:CLC, PR1, Prasugrel, Pregabalin, Progesterone caproate, Prucalopride, Pumosetrag hydrochloride; RAV-12, RB-006, RB-007, Recombinant human erythropoietin alfa, Rimonabant, Romidepsin; SAR-109659, Satraplatin, Sodium butyrate; Tadalafil, Talampanel, Tanespimycin, Tarenflurbil, Tariquidar

  19. Determinants of Bleeding Risk in Patients on Antithrombotic and Antifibrinolytic Drugs

    NARCIS (Netherlands)

    Meijer, Karina; Schulman, Sam

    2008-01-01

    The risk of bleeding associated with antithrombotic and fibrinolytic therapy depends on factors that are specific for the drugs and the patients. In this narrative review, we describe the most important risk factors for bleeding for each class of drugs. Pertinent examples are recent initiation of th

  20. The CHANGE trial

    DEFF Research Database (Denmark)

    Speyer, Helene; Christian Brix Nørgaard, Hans; Birk, Merete;

    2016-01-01

    Life expectancy in patients with schizophrenia is reduced by 20 years for men and 15 years for women compared to the general population. About 60% of the excess mortality is due to physical illnesses, with cardiovascular disease being dominant. CHANGE was a randomized, parallel-group, superiority...... cardiorespiratory fitness, physical activity, weight, diet and smoking. In conclusion, the CHANGE trial did not support superiority of individual lifestyle coaching or care coordination compared to treatment as usual in reducing cardiovascular risk in patients with schizophrenia spectrum disorders and abdominal...

  1. Gateways to clinical trials.

    Science.gov (United States)

    Bayes, M; Rabasseda, X; Prous, J R

    2002-01-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses, which has been retrieved from the Clinical Studies knowledge area of Prous Science Integrity, the world's first drug discovery and development portal, providing information on study design, treatments, conclusions and references. This issue focuses on the following selection of drugs: Abacavir sulfate; abciximab; abetimus sodium; adalimumab; aldesleukin; almotriptan; alteplase; amisulpride; amitriptyline hydrochloride; amoxicillin trihydrate; atenolol; atorvastatin calcium; atrasentan; Beclometasone dipropionate; bosentan; Captopril; ceftriaxone sodium; cerivastatin sodium; cetirizine hydrochloride; cisplatin; citalopram hydrobromide; Dalteparin sodium; darusentan; desirudin; digoxin; Efalizumab; enoxaparin sodium; ertapenem sodium; esomeprazole magnesium; estradiol; ezetimibe; Famotidine; farglitazar; fluorouracil; fluticasone propionate; fosamprenavir sodium; Glibenclamide; glucosamine sulfate; Heparin sodium; HSPPC-96; hydrochlorothiazide; Imatinib mesilate; implitapide; Lamivudine; lansoprazole; lisinopril; losartan potassium; l-Propionylcarnitine; Melagatran; metformin hydrochloride; methotrexate; methylsulfinylwarfarin; Nateglinide; norethisterone; Olmesartan medoxomil; omalizumab; omapatrilat; omeprazole; oseltamivir phosphate; oxatomide; Pantoprazole; piperacillin sodium; pravastatin sodium; Quetiapine hydrochloride; Rabeprazole sodium; raloxifene hydrochloride; ramosetron hydrochloride; ranolazine; rasburicase; reboxetine mesilate; recombinant somatropin; repaglinide; reteplase; rosiglitazone; rosiglitazone maleate; rosuvastatin calcium; Sertraline; simvastatin; sumatriptan succinate; Tazobactam sodium; tenecteplase; tibolone; tinidazole; tolterodine tartrate; troglitazone; Uniprost; Warfarin sodium; Ximelagatran. PMID:11980386

  2. Japan nuclear ship sea trial

    Energy Technology Data Exchange (ETDEWEB)

    Yamazaki, Hiroshi; Kitamura, Toshikatus; Mizushima, Toshihiko [Japan Atomic Energy Research Inst., Mutsu, Aomori (Japan). Mutsu Establishment] [and others

    1992-01-01

    The sea trial of the first Japan nuclear Ship `MUTSU` was conducted from the end of October to December in 1990. The purpose of the sea trial was to verify the nuclear propulsive performances and maneuverabilities. The present report describes the results of the sea trial. These results are classified into four items: 1. Speed test and engineering performance tests 2. Maneuvering performance tests 3. Vibration tests 4. Other tests. Acceptable performances were demonstrated, as expected in the original design. The experience of the use of the Global Positioning System (GPS), which were newly adopted for the sea trial, is also reported. (author).

  3. Japan nuclear ship sea trial

    Energy Technology Data Exchange (ETDEWEB)

    Yamazaki, Hiroshi; Kitamura, Toshikatus; Mizushima, Toshihiko (Japan Atomic Energy Research Inst., Mutsu, Aomori (Japan). Mutsu Establishment) (and others)

    1992-01-01

    The sea trial of the first Japan nuclear Ship 'MUTSU' was conducted from the end of October to December in 1990. The purpose of the sea trial was to verify the nuclear propulsive performances and maneuverabilities. The present report describes the results of the sea trial. These results are classified into four items: 1. Speed test and engineering performance tests 2. Maneuvering performance tests 3. Vibration tests 4. Other tests. Acceptable performances were demonstrated, as expected in the original design. The experience of the use of the Global Positioning System (GPS), which were newly adopted for the sea trial, is also reported. (author).

  4. Japan nuclear ship sea trial

    International Nuclear Information System (INIS)

    The sea trial of the first Japan nuclear Ship 'MUTSU' was conducted from the end of October to December in 1990. The purpose of the sea trial was to verify the nuclear propulsive performances and maneuverabilities. The present report describes the results of the sea trial. These results are classified into four items: 1. Speed test and engineering performance tests 2. Maneuvering performance tests 3. Vibration tests 4. Other tests. Acceptable performances were demonstrated, as expected in the original design. The experience of the use of the Global Positioning System (GPS), which were newly adopted for the sea trial, is also reported. (author)

  5. 全髋置换局部应用氨甲环酸后输血及成本效益分析%Postoperative Blood Loss,Transfusion and Cost Benefit Analysis of Topical Tranexamic Acid in To﹣tal Hip Arthroplasty

    Institute of Scientific and Technical Information of China (English)

    谢美兆; 练伟东; 张浩; 张智勉; 郭达

    2016-01-01

    Objective To investigate the effects of topical Tranexamic Acid technique on blood loss,transfusion and cost benefit in total hip arthroplasty(THA). Methods 80 patients underwent THA from Mar 2013 to Mar 2014 were enrolled and randomly divided into Tranexamic acid group(T group,n = 40)or Control group(C group,n = 40). In T group 2. 0 g tranex-amic acid(20 mL)were prepared. 10 mL were injected peri ﹣ articularly after prosthesis was on position. 10 mL were injected intro ﹣ articularly after iliotibial band was sutured. In C group,20 mL saline were prepared,the administration was the same with T group. visible blood loss,hidden blood loss,blood transfusion per patient,24-hour postoperative red blood cell count,he-moglobin,hematocrit,3-hour postoperative prothrombin time and activated partial thromboplastin time were recorded and com-pared. Total transfusion cost,total hospitalization cost,cost per-patient,cost-benefit ratio were recorded and counted. Results Significant differences were found in visible blood loss,hidden blood loss,blood transfusion per-patient,24-hour postoperative red blood cell count,hemoglobin,hematocrit(P ﹤ 0. 05),suggesting better blood loss control in T group than C group. No sig-nificant difference in 3-hour postoperative prothrombin time and activated partial thromboplastin time(P ﹥ 0. 05). The cost of transfusion,hospitalization,per patient were lower in T group than C group. Cost-benefit ratio was 29. 164. Conclusion Topi-cal Tranexamic Acid technique in total hip arthroplasty can obviously decrease postoperative blood loss and per patient blood transfusion,and cut down the cost of hospitalization,showing good advantage in cost-benefit control.%目的:研究全髋置换术后局部应用氨甲环酸的输血及成本效益分析。方法研究选取2013年5月至2014年5月行全髋关节置换的患者80例,随机分为氨甲环酸组(T 组)40例,对照组(C 组)40例。T 组取2.0 g(20 mL)氨甲环酸,于假

  6. Efficacy and safety of tranexamic acid on perioperative blood loss in total knee arthroplasty%氨甲环酸对全膝关节置换术围手术期失血量的影响及安全性评估

    Institute of Scientific and Technical Information of China (English)

    苗兵; 毕晓扬; 任凯晶; 于建华

    2009-01-01

    Objective To investigate the efficacy and safety of tranexamic aeid on perioperative blood loss associated with total knee arthroplasty(TKA). Methods From May 2008 to February 2009, 98 pa-tients (35 males, 63 females) underwent TKA, 66 cases with osteoarthritis, 32 with rheumatoid arthritis. The course of illness ranged from 2 to 12 years (mean, 5 years). They were randomly divided into Group A and B with 49 patients each. The patients in Group A received tranexamic acid, and the patients in Group B re-ceived an equal volume of normal saline, in Group A, 1 g of tranexamic acid dissolved in 250 ml of normal saline was intravenously infused before deflation of the tourniquet; another intravenous administration of the same drug of the same dosage was given 3 h later. In Group B, only 250 ml of normal saline was infused in-travenously. The amounts of intraoperative blood loss, postoperative wound blood loss and blood transfusion,the number of the patients needing blood transfusion and the value of postoperative hemoglobin concentration of all patients were recorded. Fibrinogen, prothrombin time, and activated partial thromboplastin time were also examined before operation, during operation (deflation of the tourniquet), and 3 hours after operation.And they were also observed for whether they had deep vein thrombosis and both lower limbs of all patients were examined by the color Doppler uhrasonography 14 days after operation. Results There was no signifi-cant difference in intraoperative blood loss botween two groups(P >0.05). There were significant differences in the amount of postoperative wound blood loss, blood transfusion, the number of the patients needing blood transfusion and the value of postoperative hemoglobin concentration between two groups, Group A were lower than Group B (P0.05). And no deep vein thrombosis was found 14 days after operation. Conclusion During and after the TKA, a short-term use of tranexamic acid can significantly decrease blood loss and

  7. 氨甲环酸对膝关节置换术患者静脉与关节内失血的影响研究%Effect of tranexamic acid on blood loss in vein and joint of patients with total knee arthroplasty

    Institute of Scientific and Technical Information of China (English)

    唐炼

    2014-01-01

    目的:研究氨甲环酸对膝关节置换术患者失血情况的影响。方法选取2012年1月~2013年12月到泸州医学院附属医院就诊并确诊为原发性骨性关节炎的患者共90例,均择期进行首次单侧全膝关节置换术,并随机将患者分为3组,实验一组采用静脉输注氨甲环酸,实验二组在膝关节局部注射氨甲环酸,实验三组不给予氨甲环酸,检测3组患者术后48 h内的血红蛋白含量和总失血量,记录7 d内的体表瘀斑情况,并进行比较。结果实验一组与实验二组术后20 h和48 h血红蛋白含量均明显多于实验三组(P<0.05);3组术后20 h和48 h血红蛋白含量均少于术前(P<0.05),且术后48 h血红蛋白含量少于术后20 h。实验一组和实验二组术后总失血量、输血例数和皮下瘀斑发生率均明显低于实验三组(P<0.05),但实验一组和实验二组之间的各项数据差异无统计学意义。所有患者均没有发生深静脉血栓。结论氨甲环酸能够减少膝关节置换术后的失血量,减轻了患者的病痛和经济负担。%Objective To study the effect of tranexamic acid on the blood loss in vein and joint of patients with total knee arthroplasty. Methods 90 patients diagnosed with primary osteoarthritis from January 2012 to December 2013 were selected as subject.They were scheduled for the first-time unilateral total knee arthroplasty.All patients were divided into three groups randomly.Experimental group one was tranexamic acid intravenously,Experiment group two was given tranexamic acid with knee local injection,and Experimental group three was given nothing.Hemoglobin and total blood loss were detected and compared in 48 hours after operation in three groups;subcutaneous ecchymosis situation within 7 days were recorded and compared.Results Hemoglobin levels of Experiment group one and Experiment group two in 20 hours and 48 hours after operation were more than

  8. Effect of tranexamic acid on risk of venous thrombosis after operation in patients undergoing revision total hip arthroplasty%氨甲环酸对全髋关节翻修术患者术后静脉血栓形成风险的影响

    Institute of Scientific and Technical Information of China (English)

    王开伟; 张辉; 张加强; 孟凡民

    2013-01-01

    目的 评价氨甲环酸对全髋关节翻修术患者术后静脉血栓形成风险的影响.方法 择期全麻下行全髋关节翻修术患者56例,性别不限,年龄35 ~ 64岁,体重指数20 ~ 25 kg/m2,ASA分级Ⅰ级或Ⅱ级,采用随机数字表法,将患者分为2组(n=28):对照组(C组)和氨甲环酸组(T组),T组气管插管后静脉注射氨甲环酸15 mg/kg,随后以10 mg·kg-1·h-1速率静脉输注至术毕,C组给予等容量生理盐水.分别于术前、术毕、术后6h及术后24h时采集静脉血样,测定血常规及凝血功能指标.记录术中出血量、自体血回收量、术后24h内引流量和异体输血情况.术后7d行下肢彩色多普勒超声检查,记录下肢深静脉血栓形成的发生情况.结果 与C组比较,T组术中出血量、自体血回收量和术后24h内引流量均减少,异体输血率降低,术毕及术后各时间点Hb和Hct均升高(P<0.05),活化部分凝血酶原时间、凝血酶原时间和纤维蛋白原差异无统计学意义(P>0.05).C组和T组下肢深静脉血栓形成发生率分别为18%和14%,组间比较差异无统计学意义(P>0.05).结论 术中静脉注射氨甲环酸15 mg/kg负荷量,随后以10 mg·kg-1·h-1速率静脉输注不增加全髋关节翻修术患者术后静脉血栓的形成.%Objective To evaluate the effect of tranexamic acid on the risk of venous thrombosis after operation in patients undergoing revision total hip arthroplasty.Methods Fifty-six ASA physical status Ⅰ or Ⅱ patients of both sexes,aged 35-64 yr,with body mass index of 20-25 kg/m2,scheduled for elective revision total hip arthroplasty,were randomly divided into 2 groups (n =28 each):control group (group C) and tranexamic acid group (group T).After induction of anesthesia,the patients were tracheally intubated and mechanically ventilated.After intubation,tranexamic acid 15 mg/kg was injected intravenously followed by infusion at a rate of 10 mg·kg-1 ·h-1 in group T,while the equal

  9. Gateways to clinical trials.

    Science.gov (United States)

    Bayes, M; Rabasseda, X; Prous, J R

    2005-01-01

    Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data in the following tables have been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: (-)-Epigallocatechin gallate; ACP-103, Ad.Egr.TNF.11 D, adalimumab, AF-IL 12, AIDSVAX gp120 B/B, alefacept, alemtuzumab, a-Galactosylceramide, ALVAC vCP 1452, alvimopan hydrate, alvocidib hydrochloride, aminolevulinic acid hydrochloride, aminolevulinic acid methyl ester, anakinra, anidulafungin, antarelix, aprepitant, aripiprazole, arsenic sulfide, asoprisnil, atazanavir sulfate, atomoxetine hydrochloride; Bevacizumab, bimatoprost, BMS-184476, bortezomib, bosentan, botulinum toxin type B, BrachySil, brivudine; Caffeine, calcipotriol/betamethasone dipropionate, cannabidiol, capsaicin for injection, caspofungin acetate, CC-4047, cetuximab, CGP-36742, clofazimine, CpG-7909, Cypher; Darbepoetin alfa, dextromethorphan/quinidine sulfate, dimethylfumarate, dronabinol/cannabidiol, drotrecogin alfa (activated), duloxetine hydrochloride, dutasteride; Ecogramostim, efalizumab, eletriptan, emtricitabine, enfuvirtide, eplerenone, esomeprazole magnesium, estradiol acetate, eszopiclone, etoricoxib, exenatide, ezetimibe, ezetimibe/simvastatin; Fampridine, fondaparinux sodium, fosamprenavir calcium; Gefitinib, GPI-0100; hA 20, HTU-PA, human insulin, HuOKT 3 gamma 1(Ala 234-Ala 235), hyaluronic acid; Icatibant, imatinib mesylate, Indiplon, INKP-100, INKP-102, iodine (I131) tositumomab, istradefylline, IV gamma-globulin, ivabradine hydrochloride, ixabepilone; Lacosamide, landiolol, lanthanum carbonate, lasofoxifene tartrate, LB-80380, lenalidomide, lidocaine/tetracaine, linezolid, liposomal doxorubicin, liposomal vincristine sulfate, lopinavir, lopinavir/ritonavir, lumiracoxib, lurtotecan; Maribavir, morphine glucuronide, MVA-5 T

  10. Gateways to clinical trials.

    Science.gov (United States)

    Tomillero, A; Moral, M A

    2008-09-01

    Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com.This issue focuses on the following selection of drugs: ABT-263, AC-2307, Aclidinium bromide, Adefovir dipivoxil, ADH-1, Agatolimod sodium, Alefacept, Aliskiren fumarate, Aminolevulinic acid methyl ester, Anakinra, Apaziquone, Aprepitant, Aripiprazole, ASM-8, Atiprimod hydrochloride, AVE-0277, AVE-1642, AVE-8062, Axitinib, Azacitidine, AZD-0530; Bazedoxifene acetate, Bevacizumab, Bexarotene, BI-2536, Biphasic insulin aspart, BMS-387032, BMS-663513, Bortezomib, BQ-123, Brivanib alaninate, BSI-201; Caspofungin acetate, CDX-110, Cetuximab, Ciclesonide, CR-011, Cypher; Daptomycin, Darbepoetin alfa, Dasatinib, Decitabine, Deferasirox, Denosumab, Dexlansoprazole, Dexmethylphenidate hydrochloride, DNA-Hsp65 vaccine, Dovitinib, Drotrecogin alfa (activated), DTaP-HBV-IPV/Hibvaccine, DTaP-IPV-HB-PRP-T, Duloxetine hydrochloride, Dutasteride; Ecogramostim, Elacytarabine, Emtricitabine, Endothelin, Entecavir, Eplivanserin fumarate, Escitalopram oxalate, Everolimus, Ezetimibe, Ezetimibe/simvastatin; Farletuzumab, Fesoterodine fumarate, Fibrin sealant (human), Fulvestrant; Gefitinib, Gemtuzumab ozogamicin, Glufosfamide, GSK-1562902A; Hib-TT; Imatinib mesylate, IMC-11F8, Imidazoacridinone, IMP-321, INCB-18424, Indiplon, Indisulam, INNO-406, Irinotecan hydrochloride/Floxuridine, ITF-2357, Ixabepilone; KRN-951; Lasofoxifene tartrate; Lenalidomide, LGD-4665, Lonafarnib, Lubiprostone, Lumiliximab; MDX-1100, Melan-A/MART-1/gp100/IFN-alfa, Methyl-CDDO, Metreleptin, MLN-2704, Mycophenolic acid sodium salt; Na-ASP-2, Naproxcinod, Nilotinib hydrochloride monohydrate, NPI-2358; Oblimersen sodium, Odanacatib; Paclitaxel nanoparticles, PAN-811, Panobinostat, PBI-1402, PC-515, Peginterferon alfa

  11. Trial encoding algorithms ensemble.

    Science.gov (United States)

    Cheng, Lipin Bill; Yeh, Ren Jye

    2013-01-01

    This paper proposes trial algorithms for some basic components in cryptography and lossless bit compression. The symmetric encryption is accomplished by mixing up randomizations and scrambling with hashing of the key playing an essential role. The digital signature is adapted from the Hill cipher with the verification key matrices incorporating un-invertible parts to hide the signature matrix. The hash is a straight running summation (addition chain) of data bytes plus some randomization. One simplified version can be burst error correcting code. The lossless bit compressor is the Shannon-Fano coding that is less optimal than the later Huffman and Arithmetic coding, but can be conveniently implemented without the use of a tree structure and improvable with bytes concatenation.

  12. 氨甲环酸预防性用药对原位肝移植术患者的血液保护效应%Blood-saving effect of prophylactic use of tranexamic acid in patients undergoing orthotopic liver transplantation

    Institute of Scientific and Technical Information of China (English)

    李兵; 张宇; 苏纲; 徐庆友

    2015-01-01

    目的 评价氨甲环酸预防性用药对肝移植术患者的血液保护效应.方法 选择同种异体原位肝移植术患者60例,年龄18~60岁,体重45 ~ 80 kg,ASA分级Ⅰ-Ⅲ级,性别不限,采用随机数字表法将患者分为2组(n=30):预防性用药组(P组)和治疗性用药组(T组).分别于麻醉诱导后即刻(T1)、无肝期30 min(T2)、新肝期30 min(T3)、新肝期2 h(T4)时取中心静脉血样,测定Fib和血小板计数;取动脉血样检测血栓弹力图(TEG)指标.T组根据TEG检测结果,若最大振幅后30 min血凝块幅度减少速率>7.5%,凝血综合指数≤1.0,提示发生原发性纤溶亢进,则静脉注射氨甲环酸15~20 mg/kg.P组于切皮即刻、门静脉阻断即刻和门静脉开放即刻,静脉注射氨甲环酸1g,若发生原发性纤溶亢进则静脉注射氨甲环酸15 ~ 20 mg/kg.记录术中出血量、液体出入量、成分输血量.记录ICU停留时间、ICU期间腹腔引流量、术后72 h内输血量,记录术后1周门静脉及肝动脉血栓的发生情况.结果 与T组比较,P组术中出血量、琥珀酰明胶注射液用量、血小板及冷沉淀用量减少,T2时Angle升高,T2.3时最大振幅后30 min血凝块幅度减少速率和T3时最大振幅升高(P<0.05),ICU停留时间、术后引流量和输血量差异无统计学意义(P>0.05).P组无一例发生原发性纤溶功能亢进.2组患者术后1周均未出现肝动脉和门静脉血栓.结论 氨甲环酸预防性用药可有效预防纤溶功能亢进,减少其导致的术中出血,且不增加血栓发生风险,血液保护效应优于TEG指导下的治疗性用药.%Objective To evaluate the blood-saving effect of prophylactic use of tranexamic acid in patients undergoing orthotopic liver transplantation.Methods Sixty ASA physical status Ⅰ-Ⅲ patients of both sexes,aged 18-60 yr,weighing 45-80 kg,scheduled for elective orthotopic liver transplantation,were randomly assigned to one of 2 groups (n =30 each) using

  13. Defendants' Rights in Criminal Trials.

    Science.gov (United States)

    Martin, Ralph C., II; Keeley, Elizabeth

    1997-01-01

    Reviews the protections afforded by the Constitution for defendants in criminal trials. These include the right to a jury trial (in cases of possible incarceration), an impartial jury, and the requirement of a unanimous verdict. Defends the use of plea bargaining as essential to an efficient criminal justice system. (MJP)

  14. Randomized clinical trials in HEPATOLOGY

    DEFF Research Database (Denmark)

    Kjaergard, L L; Nikolova, D; Gluud, C

    1999-01-01

    Evidence shows that the quality of randomized clinical trials (RCTs) affects estimates of intervention efficacy, which is significantly exaggerated in low-quality trials. The present study examines the quality of all 235 RCTs published in HEPATOLOGY from the initiation in 1981 through August 1998...

  15. Market trials of irradiated chicken

    International Nuclear Information System (INIS)

    The potential market for irradiated chicken breasts was investigated using a mail survey and a retail trial. Results from the mail survey suggested a significantly higher level of acceptability of irradiated chicken than did the retail trial. A subsequent market experiment involving actual purchases showed levels of acceptability similar to that of the mail survey when similar information about food irradiation was provided

  16. Topics in clinical trial management

    NARCIS (Netherlands)

    B.A. Kirwan (Bridget Anne)

    2004-01-01

    textabstractThe aim of this thesis is to show how clinical trial conduct can be managed while respecting the underlying scientific principles. Chapter 2 describes the main results of PICO (PImobendan in COngestive heart failure), a trial which investigated a positive inotropic agent in patients with

  17. Gateways to clinical trials.

    Science.gov (United States)

    Bayés, M; Rabasseda, X; Prous, J R

    2005-06-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables have been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: Abiraterone acetate, acyline, adalimumab, adenosine triphosphate, AEE-788, AIDSVAX gp120 B/B, AK-602, alefacept, alemtuzumab, alendronic acid sodium salt, alicaforsen sodium, alprazolam, amdoxovir, AMG-162, aminolevulinic acid hydrochloride, aminolevulinic acid methyl ester, aminophylline hydrate, anakinra, anecortave acetate, anti-CTLA-4 MAb, APC-8015, aripiprazole, aspirin, atazanavir sulfate, atomoxetine hydrochloride, atorvastatin calcium, atrasentan, AVE-5883, AZD-2171; Betamethasone dipropionate, bevacizumab, bimatoprost, biphasic human insulin (prb), bortezomib, BR-A-657, BRL-55730, budesonide, busulfan; Calcipotriol, calcipotriol/betamethasone dipropionate, calcium folinate, capecitabine, capravirine, carmustine, caspofungin acetate, cefdinir, certolizumab pegol, CG-53135, chlorambucil, ciclesonide, ciclosporin, cisplatin, clofarabine, clopidogrel hydrogensulfate, clozapine, co-trimoxazole, CP-122721, creatine, CY-2301, cyclophosphamide, cypher, cytarabine, cytolin; D0401, darbepoetin alfa, darifenacin hydrobromide, DASB, desipramine hydrochloride, desloratadine, desvenlafaxine succinate, dexamethasone, didanosine, diquafosol tetrasodium, docetaxel, doxorubicin hydrochloride, drotrecogin alfa (activated), duloxetine hydrochloride, dutasteride; Ecallantide, efalizumab, efavirenz, eletriptan, emtricitabine, enfuvirtide, enoxaparin sodium, estramustine phosphate sodium, etanercept, ethinylestradiol, etonogestrel, etonogestrel/ethinylestradiol, etoposide, exenatide; Famciclovir, fampridine, febuxostat, filgrastim, fludarabine phosphate, fluocinolone acetonide, fluorouracil, fluticasone propionate

  18. Frailty Intervention Trial (FIT

    Directory of Open Access Journals (Sweden)

    Lockwood Keri

    2008-10-01

    Full Text Available Abstract Background Frailty is a term commonly used to describe the condition of an older person who has chronic health problems, has lost functional abilities and is likely to deteriorate further. However, despite its common use, only a small number of studies have attempted to define the syndrome of frailty and measure its prevalence. The criteria Fried and colleagues used to define the frailty syndrome will be used in this study (i.e. weight loss, fatigue, decreased grip strength, slow gait speed, and low physical activity. Previous studies have shown that clinical outcomes for frail older people can be improved using multi-factorial interventions such as comprehensive geriatric assessment, and single interventions such as exercise programs or nutritional supplementation, but no interventions have been developed to specifically reverse the syndrome of frailty. We have developed a multidisciplinary intervention that specifically targets frailty as defined by Fried et al. We aim to establish the effects of this intervention on frailty, mobility, hospitalisation and institutionalisation in frail older people. Methods and Design A single centre randomised controlled trial comparing a multidisciplinary intervention with usual care. The intervention will target identified characteristics of frailty, functional limitations, nutritional status, falls risk, psychological issues and management of chronic health conditions. Two hundred and thirty people aged 70 and over who meet the Fried definition of frailty will be recruited from clients of the aged care service of a metropolitan hospital. Participants will be followed for a 12-month period. Discussion This research is an important step in the examination of specifically targeted frailty interventions. This project will assess whether an intervention specifically targeting frailty can be implemented, and whether it is effective when compared to usual care. If successful, the study will establish a

  19. Clinical Trials | Division of Cancer Prevention

    Science.gov (United States)

    Information about actively enrolling, ongoing, and completed clinical trials of cancer prevention, early detection, and supportive care, including phase I, II, and III agent and action trials and clinical trials management. |

  20. Social media in clinical trials.

    Science.gov (United States)

    Thompson, Michael A

    2014-01-01

    Social media has potential in clinical trials for pointing out trial issues, addressing barriers, educating, and engaging multiple groups involved in cancer clinical research. Social media is being used in clinical trials to highlight issues such as poor accrual and barriers; educate potential participants and physicians about clinical trial options; and is a potential indirect or direct method to improve accrual. We are moving from a passive "push" of information to patients to a "pull" of patients requesting information. Patients and advocates are often driving an otherwise reluctant health care system into communication. Online patient communities are creating new information repositories. Potential clinical trial participants are using the Twittersphere and other sources to learn about potential clinical trial options. We are seeing more organized patient-centric and patient-engaged forums with the potential to crowd source to improve clinical trial accrual and design. This is an evolving process that will meet many individual, institutional, and regulatory obstacles as we move forward in a changed research landscape.

  1. The Dynamo Clinical Trial

    Science.gov (United States)

    Ayres, Thomas R.

    2016-04-01

    The Dynamo Clinical Trial evaluates long-term stellar magnetic health through periodic X-ray examinations (by the Chandra Observatory). So far, there are only three subjects enrolled in the DTC: Alpha Centauri A (a solar-like G dwarf), Alpha Cen B (an early K dwarf, more active than the Sun), and Alpha Canis Majoris A (Procyon, a mid-F subgiant similar in activity to the Sun). Of these, Procyon is a new candidate, so it is too early to judge how it will fare. Of the other two, Alpha Cen B has responded well, with a steady magnetic heartbeat of about 8 years duration. The sickest of the bunch, Alpha Cen A, was in magnetic cardiac arrest during 2005-2010, but has begun responding to treatment in recent years, and seems to be successfully cycling again, perhaps achieving a new peak of magnetic health in the 2016 time frame. If this is the case, it has been 20 years since A's last healthful peak, significantly longer than the middle-aged Sun's 11-year magnetic heartbeat, but perhaps in line with Alpha Cen A's more senescent state (in terms of "relative evolutionary age," apparently an important driver of activity). (By the way, don't miss the exciting movie of the Alpha Cen stars' 20-year X-ray dance.)

  2. The ALCHEMIST Lung Cancer Trial

    Science.gov (United States)

    A collection of material about the ALCHEMIST lung cancer trial that will examine tumor tissue from patients with early-stage, completely resected lung cancer for gene mutations in the EGFR and ALK genes, and a

  3. Quality assurance in clinical trials.

    NARCIS (Netherlands)

    Ottevanger, P.B.; Therasse, P.; Veld, C.J.H. van de; Bernier, J.; Krieken, J.H.J.M. van; Grol, R.P.T.M.; Mulder, P.H.M. de

    2003-01-01

    From the literature that was initially searched by electronic databases using the keywords quality, quality control and quality assurance in combination with clinical trials, surgery, pathology, radiotherapy, chemotherapy and data management, a comprehensive review is given on what quality assurance

  4. National Lung Screening Trial (NLST)

    Science.gov (United States)

    The National Lung Screening Trial (NLST), a research study sponsored by the National Cancer Institute that used low-dose helical CT scans or chest X-ray to screen men and women at risk for lung cancer.

  5. Collaborative trial on groundwater sampling

    OpenAIRE

    Ghestem, Jean Philippe; Fisicaro, Paula; Champion, Rachel

    2011-01-01

    The trial presented here was conducted by BRGM in collaboration with LNE under the work program AQUAREF 2009 with the support of ONEMA. This is a collaborative trial on groundwater sampling and on field physico chemical measurement. It is not a proficiency test. He had three goals: * Observe and evaluate the practices of groundwater sampling to improve future guides, standards and specifications. * Assess the impact of sampling on variability of results. * Study the accuracy of field measurem...

  6. Maximizing scientific knowledge from randomized clinical trials

    DEFF Research Database (Denmark)

    Gustafsson, Finn; Atar, Dan; Pitt, Bertram;

    2010-01-01

    Trialists have an ethical and financial responsibility to plan and conduct clinical trials in a manner that will maximize the scientific knowledge gained from the trial. However, the amount of scientific information generated by randomized clinical trials in cardiovascular medicine is highly...... variable. Generation of trial databases and/or biobanks originating in large randomized clinical trials has successfully increased the knowledge obtained from those trials. At the 10th Cardiovascular Trialist Workshop, possibilities and pitfalls in designing and accessing clinical trial databases were...

  7. Maximizing scientific knowledge from randomized clinical trials

    DEFF Research Database (Denmark)

    Gustafsson, Finn; Atar, Dan; Pitt, Bertram;

    2010-01-01

    Trialists have an ethical and financial responsibility to plan and conduct clinical trials in a manner that will maximize the scientific knowledge gained from the trial. However, the amount of scientific information generated by randomized clinical trials in cardiovascular medicine is highly...... variable. Generation of trial databases and/or biobanks originating in large randomized clinical trials has successfully increased the knowledge obtained from those trials. At the 10th Cardiovascular Trialist Workshop, possibilities and pitfalls in designing and accessing clinical trial databases were......, in particular with respect to collaboration with the trial sponsor and to analytic pitfalls. The advantages of creating screening databases in conjunction with a given clinical trial are described; and finally, the potential for posttrial database studies to become a platform for training young scientists...

  8. Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study

    OpenAIRE

    Prayle, A.P.; Hurley, M.N.; Smyth, Alan R

    2012-01-01

    Objective To examine compliance with mandatory reporting of summary clinical trial results (within one year of completion of trial) on ClinicalTrials.gov for studies that fall under the recent Food and Drug Administration Amendments Act (FDAAA) legislation. Design Registry based study of clinical trial summaries. Data sources ClinicalTrials.gov, searched on 19 January 2011, with cross referencing with Drugs@FDA to determine for which trials mandatory reporting was required within one...

  9. Trials with a Strain Gauge.

    Science.gov (United States)

    Auty, Geoff

    1996-01-01

    Describes an attempt to match the goals of the practical demonstration of the use of a strain gauge and the technical applications of science and responding to student questions in early trials, while keeping within the level of electronics in advanced physics. (Author/JRH)

  10. The Best Bypass Surgery Trial

    DEFF Research Database (Denmark)

    Møller, Christian H; Jensen, Birte Østergaard; Gluud, Christian;

    2007-01-01

    Recent trials suggest that off-pump coronary artery bypass grafting (OPCAB) reduces the risk of mortality and morbidity compared with conventional coronary artery bypass grafting (CCAB) using cardiopulmonary bypass. Patients with a moderate- to high-risk of complications after CCAB may have...

  11. 25 CFR 11.314 - Jury trials.

    Science.gov (United States)

    2010-04-01

    ... Criminal Procedure § 11.314 Jury trials. (a) A defendant has a right, upon demand, to a jury trial in any criminal case: (1) That is punishable by a maximum sentence of one year incarceration; or (2) In which...

  12. Clinical Trials: Key to Medical Progress

    Science.gov (United States)

    Skip Navigation Bar Home Current Issue Past Issues Clinical Trials: Key to Medical Progress Past Issues / Summer 2008 ... this page please turn Javascript on. Photo iStock Clinical trials are research studies that test how well new ...

  13. Strategies to improve retention in randomised trials

    OpenAIRE

    Brueton, V. C.; Tierney, J.; Stenning, S; Harding, S; Meredith, S.; Nazareth, I; Rait, G

    2013-01-01

    Background Loss to follow-up from randomised trials can introduce bias and reduce study power, affecting the generalisability, validity and reliability of results. Many strategies are used to reduce loss to follow-up and improve retention but few have been formally evaluated. Objectives To quantify the effect of strategies to improve retention on the proportion of participants retained in randomised trials and to investigate if the effect varied by trial strategy and trial setting. Search met...

  14. HIV/AIDS Clinical Trials Fact Sheet

    Science.gov (United States)

    HIV Prevention HIV/AIDS Clinical Trials (Last updated 9/15/2015; last reviewed 9/15/2015) Key Points HIV/AIDS clinical ... safe and effective in people. What is an HIV/AIDS clinical trial? HIV/AIDS clinical trials help ...

  15. The Design of Cluster Randomized Crossover Trials

    Science.gov (United States)

    Rietbergen, Charlotte; Moerbeek, Mirjam

    2011-01-01

    The inefficiency induced by between-cluster variation in cluster randomized (CR) trials can be reduced by implementing a crossover (CO) design. In a simple CO trial, each subject receives each treatment in random order. A powerful characteristic of this design is that each subject serves as its own control. In a CR CO trial, clusters of subjects…

  16. Clinical Trials Management | Division of Cancer Prevention

    Science.gov (United States)

    Information for researchers about developing, reporting, and managing NCI-funded cancer prevention clinical trials. Protocol Information Office The central clearinghouse for clinical trials management within the Division of Cancer Prevention.Read more about the Protocol Information Office. | Information for researchers about developing, reporting, and managing NCI-funded cancer prevention clinical trials.

  17. Trial-to-Trial Fluctuations in Attentional State and Their Relation to Intelligence

    Science.gov (United States)

    Unsworth, Nash; McMillan, Brittany D.

    2014-01-01

    Trial-to-trial fluctuations in attentional state while performing measures of intelligence were examined in the current study. Participants performed various measures of fluid and crystallized intelligence while also providing attentional state ratings prior to each trial. It was found that pre-trial attentional state ratings strongly predicted…

  18. Accrual to Cancer Clinical Trials

    LENUS (Irish Health Repository)

    Kelly, C

    2016-07-01

    Accrual to cancer clinical trials (CCT) is imperative to safeguard continued improvement in cancer outcomes. A retrospective chart review was performed of patients (n=140) starting a new anti-cancer agent in a north Dublin cancer centre. This review was performed over a four-month period, beginning in November 2015. Only 29% (n=41) had a CCT option. The overall accrual rate to CCT was 5% (n=7), which is comparable to internationally reported figures. The main reasons for failure to recruit to CCT included the lack of a CCT option for cancer type (n=30, 23%), stage (n=25, 19%), and line of treatment (n=23, 17%). Over the last decade, the rate of accrual to CCTs has in fact doubled and the number of trials open to recruitment has tripled. Ongoing governmental and philanthropic support is necessary to continue this trend to further expand CCT patient options with a target accrual rate of 10%.

  19. Human clinical trials in antiepileptogenesis

    OpenAIRE

    Mani, Ram; Pollard, John; Dichter, Marc A.

    2011-01-01

    Blocking the development of epilepsy (epileptogenesis) is a fundamental research area with the potential to provide large benefits to patients by avoiding the medical and social consequences that occur with epilepsy and lifelong therapy. Human clinical trials attempting to prevent epilepsy (antiepileptogenesis) have been few and universally unsuccessful to date. In this article, we review data about possible pathophysiological mechanisms underlying epileptogenesis, discuss potential intervent...

  20. Clinical trials and gender medicine

    Directory of Open Access Journals (Sweden)

    Mariarita Cassese

    2011-01-01

    Full Text Available Women use more medicines than men because they fall ill more often and suffer more from chronic diseases, but also because women pay more attention to their health and have more consciousness and care about themselves. Although medicines can have different effects on women and men, women still represent a small percentage in the first phases of trials (22% which are essential to verify drugs dosage, side effects, and safety. Even though women are more present in trials, studies results are not presented with a gender approach. This situation is due to educational, social, ethical and economical factors. The scientific research must increase feminine presence in clinical trials in order to be equal and correct, and all the key stakeholder should be involved in this process. We still have a long way to cover and it doesn't concern only women but also children and old people. The aim is to have a medicine not only illness-focused but patient-focused: a medicine able to take into consideration all the patient characteristics and so to produce a really personalized therapy. What above described is part of the reasons why in 2005 was founded the National Observatory for Women's Health (Osservatorio Nazionale sulla Salute della Donna, ONDa which promotes a gender health awareness and culture in Italy, at all the levels of the civil and scientific society.

  1. The DiaS trial

    DEFF Research Database (Denmark)

    Andreasson, Kate; Krogh, Jesper; Rosenbaum, Bent;

    2014-01-01

    BACKGROUND: In Denmark 8,000 to 10,000 people will attempt suicide each year. The Centre of Excellence in Suicide Prevention in the Capital Region of Denmark is treating patients with suicidal behavior, and a recent survey has shown that 30% of the patients are suffering from borderline personali...... measured at week 28. Other exploratory outcomes are included such as severity of symptoms, suicide intention and ideation, depression, hopelessness, self-esteem, impulsivity, anger, and duration of respective treatments. TRIAL REGISTRATION: Clinical Trial.gov: NCT01512602....... disorder. The majority of patients (70% to 75%) with borderline personality disorder have a history of deliberate self-harm and 10% have a lifetime risk to die by suicide. The DiaS trial is comparing dialectical behavior therapy with collaborative assessment and management of suicidality......-informed supportive psychotherapy, for the risk of repetition of deliberate self-harm in patients with a recent suicide attempt and personality traits within the spectrum of borderline personality disorder. Both treatments have previously shown effects in this group of patients on suicide ideation and self...

  2. Market Trials of Irradiated Spices

    International Nuclear Information System (INIS)

    Full text: The objectives of the experiment were to disseminate irradiated retail foods to the domestic publics and to test consumer acceptance on irradiated ground chilli and ground pepper. Market trials of irradiated ground chilli and ground pepper were carried out at 2 local markets and 4 in Bangkok and Nontaburi in 2005-2007. Before the start of the experiment, processing room, gamma irradiation room and labels of the products were approved by Food and Drug Administration, Thailand. 50 grams of irradiated products were packaged in plastic bags for the market trials. 688 and 738 bags of ground chilli and ground pepper were sold, respectively. Questionnaires distributed with the products were commented by 59 consumers and statistically analyzed by experimental data pass program. 88.1 and 91.4 percents of the consumers were satisfied with the quality and the price, respectively. 79.7% of the consumers chose to buy irradiated ground chilli and ground pepper because they believed that the quality of irradiated products were better than that of non-irradiated ones. 91.5% of the consumers would certainly buy irradiated chilli and pepper again. Through these market trials, it was found that all of the products were sold out and the majority of the consumers who returned the questionnaires was satisfied with the irradiated ground chilli and ground pepper and also had good attitude toward irradiated foods

  3. Potential Representation - Global vs. Local Trial Functions

    Science.gov (United States)

    Michel, Volker

    2014-05-01

    Many systems of trial functions are available for representing potential fields on the sphere or parts of the sphere. We distinguish global trial functions (such as spherical harmonics) from localized trial functions (such as spline basis functions, scaling functions, wavelets, and Slepian functions). All these systems have their own pros and cons. We discuss the advantages and disadvantages of several selected systems of trial functions and propose criteria for their applicability. Moreover, we present an algorithm which is able to combine different types of trial functions. This yields a sparser solution which combines the features of the different basis systems which are used.

  4. -ctgov-: A suite of Stata commands for reporting trial results to ClinicalTrials.gov

    OpenAIRE

    Phil Schumm; Theodore Karrison

    2014-01-01

    In response to the 1997 Food and Drug Administration Modernization Act (FDAMA), the National Institutes of Health (NIH) established ClinicalTrials.gov, an online, publicly-accessible registry for clinical trials. The 2007 Food and Drug Administration Amendments Act (FDAAA) broadened the scope of eligible trials, added outcomes reporting as a requirement, and established penalties for non-compliance. Although ClinicalTrials.gov increased the transparency with which clinical trials are conducte...

  5. Data monitoring committees for pragmatic clinical trials.

    Science.gov (United States)

    Ellenberg, Susan S; Culbertson, Richard; Gillen, Daniel L; Goodman, Steven; Schrandt, Suzanne; Zirkle, Maryan

    2015-10-01

    In any clinical trial, it is essential to monitor the accumulating data to be sure that the trial continues to be safe for participants and that the trial is being conducted properly. Data monitoring committees, independent expert panels who undertake regular reviews of the data as the trial progresses, serve an important role in safeguarding the interests of research participants and ensuring trial integrity in many trials. Many pragmatic clinical trials, which aim to inform healthcare decisions by comparing alternate interventions in heterogeneous healthcare delivery settings, will warrant review by an independent data monitoring committee due to their potential impact on clinical practice. However, the very features that make a trial "pragmatic" may pose challenges in terms of which aspects of a trial to monitor and when it is appropriate for a data monitoring committee to intervene. Using the Pragmatic-Explanatory Continuum Indicator Summary tool that draws distinctions between pragmatic and explanatory clinical trials, we review characteristics of pragmatic clinical trials that may have implications for data monitoring committees and interim monitoring plans. These include broad eligibility criteria, a focus on subjective patient-centered outcomes, and in some cases a lack of standardized follow-up procedures across study sites. Additionally, protocol adherence is often purposefully not addressed in pragmatic trials in order to accurately represent the clinical practice setting and maintain practicability of implementation; there are differing viewpoints as to whether adherence should be assessed and acted upon by data monitoring committees in these trials. Some other issues not specifically related to the Pragmatic-Explanatory Continuum Indicator Summary criteria may also merit special consideration in pragmatic trials. Thresholds for early termination of a pragmatic clinical trial might be controversial. The distinguishing features of pragmatic clinical

  6. Clinical Trials in Peripheral Vascular Disease: Pipeline and Trial Designs: An Evaluation of the ClinicalTrials.gov Database

    Science.gov (United States)

    Subherwal, Sumeet; Patel, Manesh R.; Chiswell, Karen; Tidemann-Miller, Beth A.; Jones, W. Schuyler; Conte, Michael S.; White, Christopher J.; Bhatt, Deepak L.; Laird, John R.; Hiatt, William R.; Tasneem, Asba; Califf, Robert M.

    2014-01-01

    Background Tremendous advances have occurred in therapies for peripheral vascular disease (PVD); however, until recently it has not been possible to examine the entire clinical trial portfolio of studies for treatment of PVD (both arterial and venous disease). Methods and Results We examined interventional trials registered in ClinicalTrials.gov from October 2007 through September 2010 (n=40,970) and identified 676 (1.7%) PVD trials (n=493 arterial only, n=170 venous only, n=13 both arterial and venous). Most arterial studies investigated lower extremity peripheral artery disease and acute stroke (35% and 24%, respectively), while most venous studies examined deep vein thrombosis/pulmonary embolus prevention (42%) or venous ulceration (25%). A placebo-controlled trial design was used in 27% of the PVD trials, and 4% of the PVD trials excluded patients aged >65 years. Enrollment in at least 1 US site decreased from 51% in 2007 to 41% of trials in 2010. Compared with non-cardiology disciplines, PVD trials were more likely to be double-blinded, investigate use of devices and procedures, and have industry sponsorship and assumed funding source, and less likely to investigate drug and behavioral therapies. Geographic access to PVD clinical trials within the United States is limited to primarily large metropolitan areas. Conclusions PVD studies represent a small group of trials registered in ClinicalTrials.gov, despite the high prevalence of vascular disease in the general population. This low number, compounded by the decreasing number of PVD trials in the United States, is concerning and may limit the ability to inform current clinical practice of patients with PVD. PMID:25239436

  7. Microbicide clinical trial adherence: insights for introduction

    Directory of Open Access Journals (Sweden)

    Cynthia Woodsong

    2013-04-01

    Full Text Available After two decades of microbicide clinical trials it remains uncertain if vaginally- delivered products will be clearly shown to reduce the risk of HIV infection in women and girls. Furthermore, a microbicide product with demonstrated clinical efficacy must be used correctly and consistently if it is to prevent infection. Information on adherence that can be gleaned from microbicide trials is relevant for future microbicide safety and efficacy trials, pre-licensure implementation trials, Phase IV post-marketing research, and microbicide introduction and delivery. Drawing primarily from data and experience that has emerged from the large-scale microbicide efficacy trials completed to-date, the paper identifies six broad areas of adherence lessons learned: (1 Adherence measurement in clinical trials, (2 Comprehension of use instructions/Instructions for use, (3 Unknown efficacy and its effect on adherence/Messages regarding effectiveness, (4 Partner influence on use, (5 Retention and continuation and (6 Generalizability of trial participants' adherence behavior. Each is discussed, with examples provided from microbicide trials. For each of these adherence topics, recommendations are provided for using trial findings to prepare for future microbicide safety and efficacy trials, Phase IV post-marketing research, and microbicide introduction and delivery programs.

  8. Microbicide clinical trial adherence: insights for introduction.

    Science.gov (United States)

    Woodsong, Cynthia; MacQueen, Kathleen; Amico, K Rivet; Friedland, Barbara; Gafos, Mitzy; Mansoor, Leila; Tolley, Elizabether; McCormack, Sheena

    2013-01-01

    After two decades of microbicide clinical trials it remains uncertain if vaginally- delivered products will be clearly shown to reduce the risk of HIV infection in women and girls. Furthermore, a microbicide product with demonstrated clinical efficacy must be used correctly and consistently if it is to prevent infection. Information on adherence that can be gleaned from microbicide trials is relevant for future microbicide safety and efficacy trials, pre-licensure implementation trials, Phase IV post-marketing research, and microbicide introduction and delivery. Drawing primarily from data and experience that has emerged from the large-scale microbicide efficacy trials completed to-date, the paper identifies six broad areas of adherence lessons learned: (1) Adherence measurement in clinical trials, (2) Comprehension of use instructions/Instructions for use, (3) Unknown efficacy and its effect on adherence/Messages regarding effectiveness, (4) Partner influence on use, (5) Retention and continuation and (6) Generalizability of trial participants' adherence behavior. Each is discussed, with examples provided from microbicide trials. For each of these adherence topics, recommendations are provided for using trial findings to prepare for future microbicide safety and efficacy trials, Phase IV post-marketing research, and microbicide introduction and delivery programs. PMID:23561044

  9. Gatekeepers for pragmatic clinical trials.

    Science.gov (United States)

    Whicher, Danielle M; Miller, Jennifer E; Dunham, Kelly M; Joffe, Steven

    2015-10-01

    To successfully implement a pragmatic clinical trial, investigators need access to numerous resources, including financial support, institutional infrastructure (e.g. clinics, facilities, staff), eligible patients, and patient data. Gatekeepers are people or entities who have the ability to allow or deny access to the resources required to support the conduct of clinical research. Based on this definition, gatekeepers relevant to the US clinical research enterprise include research sponsors, regulatory agencies, payers, health system and other organizational leadership, research team leadership, human research protections programs, advocacy and community groups, and clinicians. This article provides a framework to help guide gatekeepers' decision-making related to the use of resources for pragmatic clinical trials. Relevant ethical considerations for gatekeepers include (1) concern for the interests of individuals, groups, and communities affected by the gatekeepers' decisions, including protection from harm and maximization of benefits; (2) advancement of organizational mission and values; and (3) stewardship of financial, human, and other organizational resources. Separate from these ethical considerations, gatekeepers' actions will be guided by relevant federal, state, and local regulations. This framework also suggests that to further enhance the legitimacy of their decision-making, gatekeepers should adopt transparent processes that engage relevant stakeholders when feasible and appropriate. We apply this framework to the set of gatekeepers responsible for making decisions about resources necessary for pragmatic clinical trials in the United States, describing the relevance of the criteria in different situations and pointing out where conflicts among the criteria and relevant regulations may affect decision-making. Recognition of the complex set of considerations that should inform decision-making will guide gatekeepers in making justifiable choices regarding

  10. Making randomised trials more efficient: report of the first meeting to discuss the Trial Forge platform.

    Science.gov (United States)

    Treweek, Shaun; Altman, Doug G; Bower, Peter; Campbell, Marion; Chalmers, Iain; Cotton, Seonaidh; Craig, Peter; Crosby, David; Davidson, Peter; Devane, Declan; Duley, Lelia; Dunn, Janet; Elbourne, Diana; Farrell, Barbara; Gamble, Carrol; Gillies, Katie; Hood, Kerry; Lang, Trudie; Littleford, Roberta; Loudon, Kirsty; McDonald, Alison; McPherson, Gladys; Nelson, Annmarie; Norrie, John; Ramsay, Craig; Sandercock, Peter; Shanahan, Daniel R; Summerskill, William; Sydes, Matt; Williamson, Paula; Clarke, Mike

    2015-06-05

    Randomised trials are at the heart of evidence-based healthcare, but the methods and infrastructure for conducting these sometimes complex studies are largely evidence free. Trial Forge ( www.trialforge.org ) is an initiative that aims to increase the evidence base for trial decision making and, in doing so, to improve trial efficiency.This paper summarises a one-day workshop held in Edinburgh on 10 July 2014 to discuss Trial Forge and how to advance this initiative. We first outline the problem of inefficiency in randomised trials and go on to describe Trial Forge. We present participants' views on the processes in the life of a randomised trial that should be covered by Trial Forge.General support existed at the workshop for the Trial Forge approach to increase the evidence base for making randomised trial decisions and for improving trial efficiency. Agreed upon key processes included choosing the right research question; logistical planning for delivery, training of staff, recruitment, and retention; data management and dissemination; and close down. The process of linking to existing initiatives where possible was considered crucial. Trial Forge will not be a guideline or a checklist but a 'go to' website for research on randomised trials methods, with a linked programme of applied methodology research, coupled to an effective evidence-dissemination process. Moreover, it will support an informal network of interested trialists who meet virtually (online) and occasionally in person to build capacity and knowledge in the design and conduct of efficient randomised trials.Some of the resources invested in randomised trials are wasted because of limited evidence upon which to base many aspects of design, conduct, analysis, and reporting of clinical trials. Trial Forge will help to address this lack of evidence.

  11. Lessons from the SYNTAX trial

    OpenAIRE

    Alamri, Hussein S.; Alotaiby, Mohammed; ALmoghairi, Abdulrahman; El Oakley, Rieda M.

    2010-01-01

    Despite the fact that CABG is the standard of care for patients with multivessel coronary arteries and/or left main stem stenosis, PCI has become a rival to CABG in patients with multivessel coronary artery disease or left main disease. However, the need for repeat revascularization, in-stent stenosis and thrombosis remain the achilis heal of PCI. SYNTAX trial randomized patients with left main disease and/or three-vessel disease to PCI with TAXus stent or CABG with the concept that PCI is no...

  12. Juvenile Competency to Stand Trial.

    Science.gov (United States)

    Stepanyan, Sofia T; Sidhu, Shawn S; Bath, Eraka

    2016-01-01

    Competency to stand trial is interpreted as a protected due process right for all defendants and is defined as a defendant's fundamental knowledge and understanding of the criminal charges being filed, roles and procedures within the courtroom, and a general ability to work with the defense counsel. Questions of competency are most often raised by the judge, defense, or the prosecution, and competency evaluations are most often completed by psychiatrists or psychologists with forensic training or work experience. Mental illness, intellectual disability, developmental disorders, and developmental immaturity are the 4 main factors considered in most juvenile competency evaluations. PMID:26593118

  13. The L'Aquila trial

    OpenAIRE

    Cocco, M.; Istituto Nazionale di Geofisica e Vulcanologia, Sezione Roma1, Roma, Italia; Cultrera, G.; Istituto Nazionale di Geofisica e Vulcanologia, Sezione Roma1, Roma, Italia; Amato, A.; Istituto Nazionale di Geofisica e Vulcanologia, Sezione CNT, Roma, Italia; Braun, T.; Istituto Nazionale di Geofisica e Vulcanologia, Sezione Roma1, Roma, Italia; Cerase, A.; Dipartimento di Comunicazione e Ricerca Sociale, Univ. La Sapienza, Roma, Italy; Margheriti, L.; Istituto Nazionale di Geofisica e Vulcanologia, Sezione CNT, Roma, Italia; Bonaccorso, A.; Istituto Nazionale di Geofisica e Vulcanologia, Sezione Catania, Catania, Italia; Demartin, M..; Istituto Nazionale di Geofisica e Vulcanologia, Sezione CNT, Roma, Italia; De Martini, P. M.; Istituto Nazionale di Geofisica e Vulcanologia, Sezione Roma1, Roma, Italia; Galadini, F.; Istituto Nazionale di Geofisica e Vulcanologia, Sezione Roma1, Roma, Italia; Meletti, C.; Istituto Nazionale di Geofisica e Vulcanologia, Sezione Milano-Pavia, Milano, Italia; Nostro, C.; Istituto Nazionale di Geofisica e Vulcanologia, Sezione CNT, Roma, Italia; Pacor, F.; Istituto Nazionale di Geofisica e Vulcanologia, Sezione Milano-Pavia, Milano, Italia; Pantosti, D.; Istituto Nazionale di Geofisica e Vulcanologia, Sezione Roma1, Roma, Italia; Pondrelli, S.; Istituto Nazionale di Geofisica e Vulcanologia, Sezione Bologna, Bologna, Italia

    2015-01-01

    The first stage of the trial in L’Aquila (Italy) ended with a conviction of seven experts, convened by the head of Civil Protection on 31 March 2009, for multiple manslaughter and serious injuries. They were sentenced to six years in jail, perpetual interdiction from public office and a fine of several million euros to be paid to the victims of the earthquake of 6 April 2009 (moment magnitude 6.3) for having caused, by their negligent conduct, the death of 29 persons and the injury of seve...

  14. Mobiilipeligrafiikan optimointi : Case: Trials Frontier

    OpenAIRE

    Palmi, Daniel

    2013-01-01

    Opinnäytetyön tavoitteena on tuoda esille merkittävimmät tekniikat ja seikat peligrafiikan optimointiin 3d-graafikon näkökulmasta. Oppimani tekniikat liittyvät tiiviisti Trials Frontier – mobiilipeliin, joka on kirjoitushetkellä kehitteillä Redlynx Ubisoft -studiossa. Olen projektis-sa 3d-graafikkona ja luonut peliin suurimman osan 3d-objekteista. Projektin parissa on työn kautta tullut opittua monia tekniikoita reaaliaikaisen grafiikan optimointiin ja esitän tässä opinnäytetyössä keskeisimmä...

  15. Trial and Numerical Analysis of Specimen Pipelay

    Institute of Scientific and Technical Information of China (English)

    何炎平; 邓德衡; 谭家华; 顾敏童

    2002-01-01

    Subsea pipelay has a relatively long history. In recent years, there has been a domestic need for the laying of largediameter thin wall pipes. A land-based trial for the large diameter thin wall specimen pipe is described in this paper. Re-gression analysis is performed for the trial data and the formula derived can express the trial data very well. Numericalanalysis is adopted to compute various trial conditions. Then the numerical model is revised with the trial results, whichare consistent with each other. After summarization of the results of trial and numerical analysis, the characteristics aredescribed of the spatial configuration during the laying of the pipe and it is concluded that the maximum strain appearsaround the center of the raised pipeline. In the end, a reference standard, which limits the maximum stress below theyield stress is provided.

  16. OARSI Clinical Trials Recommendations: Design and conduct of clinical trials of rehabilitation interventions for osteoarthritis.

    Science.gov (United States)

    Fitzgerald, G K; Hinman, R S; Zeni, J; Risberg, M A; Snyder-Mackler, L; Bennell, K L

    2015-05-01

    A Task Force of the Osteoarthritis Research Society International (OARSI) has previously published a set of guidelines for the conduct of clinical trials in osteoarthritis (OA) of the hip and knee. Limited material available on clinical trials of rehabilitation in people with OA has prompted OARSI to establish a separate Task Force to elaborate guidelines encompassing special issues relating to rehabilitation of OA. The Task Force identified three main categories of rehabilitation clinical trials. The categories included non-operative rehabilitation trials, post-operative rehabilitation trials, and trials examining the effectiveness of devices (e.g., assistive devices, bracing, physical agents, electrical stimulation, etc.) that are used in rehabilitation of people with OA. In addition, the Task Force identified two main categories of outcomes in rehabilitation clinical trials, which include outcomes related to symptoms and function, and outcomes related to disease modification. The guidelines for rehabilitation clinical trials provided in this report encompass these main categories. The report provides guidelines for conducting and reporting on randomized clinical trials. The topics include considerations for entering patients into trials, issues related to conducting trials, considerations for selecting outcome measures, and recommendations for statistical analyses and reporting of results. The focus of the report is on rehabilitation trials for hip, knee and hand OA, however, we believe the content is broad enough that it could be applied to rehabilitation trials for other regions as well.

  17. Internet trials: participant experiences and perspectives

    OpenAIRE

    Mathieu Erin; Barratt Alexandra; Carter Stacy M; Jamtvedt Gro

    2012-01-01

    Abstract Background Use of the Internet to conduct randomised controlled trials is increasing, and provides potential to increase equity of access to medical research, increase the generalisability of trial results and decrease the costs involved in conducting large scale trials. Several studies have compared response rates, completeness of data, and reliability of surveys using the Internet and traditional methods, but very little is known about participants’ attitudes towards Internet-based...

  18. Traversing the Translational Trail for Trials

    OpenAIRE

    Steeves, John D.; John L. K. Kramer; Zariffa, Jose

    2012-01-01

    The principles of spinal cord injury clinical trial programs are briefly reviewed as one example of the challenge faced by most human studies of neurologically directed therapeutic interventions, including rehabilitation strategies. Different trial protocols are reviewed, as are inclusion/exclusion criteria for study subjects, the choice of clinical endpoints, and the statistical approaches that might be used in a trial program. Potential factors that might confound the accurate interpretatio...

  19. The Clinical Trials Transformation Initiative (CTTI)

    OpenAIRE

    Alberto Grignolo

    2011-01-01

    The Clinical Trials Transformation Initiative (CTTI) is a public-private partnership created in 2007 between the United States Food and Drug Administration (FDA) and Duke University for the purpose of identifying practices that will increase the quality and efficiency of clinical trials. The initiative was generated from the realization that the clinical trials system in the United States has been suffering as a result of increasingly longer study start-up times, slowing enrollment of patient...

  20. Methodological Issues in Negative Symptom Trials

    OpenAIRE

    Marder, Stephen R.; Daniel, David G; Alphs, Larry; Awad, A George; Richard S E Keefe

    2011-01-01

    Individuals from academia, the pharmaceutical industry, and the US Food and Drug Administration used a workshop format to discuss important methodological issues in the design of trials of pharmacological agents for improving negative symptoms in schizophrenia. The issues addressed included the need for a coprimary functional measure for registration trials; the characteristics of individuals who should enter negative symptom trials; the optimal duration for a proof-of-concept or registration...

  1. Potential bias in ophthalmic pharmaceutical clinical trials

    OpenAIRE

    Paul Varner

    2008-01-01

    Paul VarnerJohn J Pershing Veterans’ Administration Medical Center, Poplar Bluff, Missouri, USAAbstract: To make clinicians aware of potential sources of error in ophthalmic pharmaceutical clinical trials that can lead to erroneous interpretation of results, a critical review of the study design of various pharmaceutical ophthalmic clinical trials was completed. Discrepancies as a result of study shortcomings may explain observed differences between reported ophthalmic trial data an...

  2. Single-Trial Inference on Visual Attention

    DEFF Research Database (Denmark)

    Dyrholm, Mads; Kyllingsbæk, Søren; Vangkilde, Signe Allerup;

    2011-01-01

    In this paper we take a step towards single-trial behavioral modeling within a Theory of Visual Attention (TVA). In selective attention tasks, such as the Partial Report paradigm, the subject is asked to ignore distractors and only report stimuli that belong to the target class. Nothing about...... Report trial. This result retrodicts a latent attentional state of the subject using the observed response from that particular trial and thus differs from other predictions made with TVA which are based on expected values of observed variables. We show an example of the result in single-trial analysis...

  3. Single-Trial Inference on Visual Attention

    DEFF Research Database (Denmark)

    Dyrholm, Mads; Kyllingsbæk, Søren; Vangkilde, Signe Allerup;

    In this paper we take a step towards single-trial behavioral modeling within a Theory of Visual Attention (TVA). In selective attention tasks, such as the Partial Report paradigm, the subject is asked to ignore distractors and only report stimuli that belong to the target class. Nothing about...... Report trial. This result retrodicts a latent attentional state of the subject using the observed response from that particular trial and thus differs from other predictions made with TVA which are based on expected values of observed variables. We show an example of the result in single-trial analysis...

  4. How Experimental Trial Context Affects Perceptual Categorization

    Directory of Open Access Journals (Sweden)

    Thomas J Palmeri

    2015-02-01

    Full Text Available To understand object categorization, participants are tested in experiments often quite different from how people experience object categories in the real world. Learning and knowledge of categories is measured in discrete experimental trials, those trials may or may not provide feedback, trials appear one after another, after some fixed inter-trial interval, with hundreds of trials in a row, within experimental blocks with some structure dictated by the experimental design. In the real world, outside of certain educational and vocational contexts, opportunities to learn and use categories are intermixed over time with a whole multitude of intervening experiences. It is clear from any elementary understanding of human cognition that sequential effects matter, yet this understanding is often ignored, and categorization trials are often instead treated as independent events, immune to local trial context. In this perspective, we use some of our work to illustrate some of the consequences of the fact that categorization experiments have a particular trial structure. Experimental trial context can affect performance in category learning and categorization experiments in ways that can profoundly affect theoretical conclusions.

  5. Power analysis of trials with multilevel data

    CERN Document Server

    Moerbeek, Mirjam

    2015-01-01

    Power Analysis of Trials with Multilevel Data covers using power and sample size calculations to design trials that involve nested data structures. The book gives a thorough overview of power analysis that details terminology and notation, outlines key concepts of statistical power and power analysis, and explains why they are necessary in trial design. It guides you in performing power calculations with hierarchical data, which enables more effective trial design.The authors are leading experts in the field who recognize that power analysis has attracted attention from applied statisticians i

  6. The L'Aquila trial

    Science.gov (United States)

    Amato, Alessandro; Cocco, Massimo; Cultrera, Giovanna; Galadini, Fabrizio; Margheriti, Lucia; Nostro, Concetta; Pantosti, Daniela

    2013-04-01

    The first step of the trial in L'Aquila (Italy) ended with a conviction of a group of seven experts to 6 years of jail and several million euros refund for the families of the people who died during the Mw 6.3 earthquake on April 6, 2009. This verdict has a tremendous impact on the scientific community as well as on the way in which scientists deliver their expert opinions to decision makers and society. In this presentation, we describe the role of scientists in charge of releasing authoritative information concerning earthquakes and seismic hazard and the conditions that led to the verdict, in order to discuss whether this trial represented a prosecution to science, and if errors were made in communicating the risk. Documents, articles and comments about the trial are collected in the web site http://processoaquila.wordpress.com/. We will first summarize what was the knowledge about the seismic hazard of the region and the vulnerability of L'Aquila before the meeting of the National Commission for Forecasting and Predicting Great Risks (CGR) held 6 days before the main shock. The basic point of the accusation is that the CGR suggested that no strong earthquake would have occurred (which of course was never mentioned by any seismologist participating to the meeting). This message would have convinced the victims to stay at home, instead of moving out after the M3.9 and M3.5 earthquakes few hours before the mainshock. We will describe how the available scientific information was passed to the national and local authorities, and in general how the Italian scientific Institution in charge of seismic monitoring and research (INGV), the Civil Protection Department (DPC) and the CGR should interact according to the law. As far as the communication and outreach to the public, the scientific Institutions as INGV have the duty to communicate scientific information. Instead, the risk management and the definition of actions for risk reduction is in charge of Civil

  7. National Lung Screening Trial Results: Fast Facts

    Science.gov (United States)

    On November 4, 2010, the NLST reported initial trial results, showing 20 percent fewer lung cancer deaths among trial participants screened with low-dose helical CT (also known as spiral CT) compared to those who got screened with chest X-rays.

  8. Alien wavelength modeling tool and field trial

    DEFF Research Database (Denmark)

    Sambo, N.; Sgambelluri, A.; Secondini, M.;

    2015-01-01

    A modeling tool is presented for pre-FEC BER estimation of PM-QPSK alien wavelength signals. A field trial is demonstrated and used as validation of the tool's correctness. A very close correspondence between the performance of the field trial and the one predicted by the modeling tool has been...

  9. Controversy, Trials, and Crime--Oh My!

    Science.gov (United States)

    Rott, Kim

    2006-01-01

    Teenagers' innate interest with the justice system is one of the reasons that so many high school literary classics teem with criminals, controversial issues, and trials. Novels such as "To Kill a Mockingbird," "A Separate Peace," "The Crucible," and "Twelve Angry Men" feature high-impact trials. In the author's desire to tap into this interest,…

  10. Homo Economicus and the Salem Witch Trials.

    Science.gov (United States)

    Mixon, Franklin G., Jr.

    2000-01-01

    Provides background information on the Salem Witch Trials (Salem, Massachusetts) and the medical explanation of the young village girls' behavior in Salem called ergotism (bread poisoning). Presents an economic interpretation of those trials, stating that the ministers employed religious beliefs about witchcraft to maintain their churchs' monopoly…

  11. The design of cluster randomized crossover trials

    NARCIS (Netherlands)

    Rietbergen, C.; Moerbeek, M.

    2011-01-01

    The inefficiency induced by between-cluster variation in cluster randomized (CR) trials can be reduced by implementing a crossover (CO) design. In a simple CO trial, each subject receives each treatment in random order. A powerful characteristic of this design is that each subject serves as its own

  12. International Clinical Trials Registry Platform (ICTRP)

    Institute of Scientific and Technical Information of China (English)

    2011-01-01

    @@ Introduction The mission of the WHO Intemational Clinical Trials Registry Platform is to ensure that a complete view of research is accessible to all those involved in health care decision making.This will improve research transparency and will ultimately strengthen tha validity and value of the scientific evidence base.The registration of all interventional trials is a scientific, ethical and moral responsibility.

  13. Blinded trials taken to the test

    DEFF Research Database (Denmark)

    Hróbjartsson, A; Forfang, E; Haahr, M T;

    2007-01-01

    Blinding can reduce bias in randomized clinical trials, but blinding procedures may be unsuccessful. Our aim was to assess how often randomized clinical trials test the success of blinding, the methods involved and how often blinding is reported as being successful....

  14. The Child and Adolescent Psychiatry Trials Network

    Science.gov (United States)

    March, John S.; Silva, Susan G.; Compton, Scott; Anthony, Ginger; DeVeaugh-Geiss, Joseph; Califf, Robert; Krishnan, Ranga

    2004-01-01

    Objective: The current generation of clinical trials in pediatric psychiatry often fails to maximize clinical utility for practicing clinicians, thereby diluting its impact. Method: To attain maximum clinical relevance and acceptability, the Child and Adolescent Psychiatry Trials Network (CAPTN) will transport to pediatric psychiatry the practical…

  15. Ethics of clinical trials in Nigeria.

    Science.gov (United States)

    Okonta, Patrick I

    2014-05-01

    The conduct of clinical trials for the development and licensing of drugs is a very important aspect of healthcare. Drug research, development and promotion have grown to a multi-billion dollar global business. Like all areas of human endeavour involving generation and control of huge financial resources, it could be subject to deviant behaviour, sharp business practices and unethical practices. The main objective of this review is to highlight potential ethical challenges in the conduct of clinical trials in Nigeria and outline ways in which these can be avoided. Current international and national regulatory and ethical guidelines are reviewed to illustrate the requirements for ethical conduct of clinical trials. Past experiences of unethical conduct of clinical trials especially in developing countries along with the increasing globalisation of research makes it imperative that all players should be aware of the ethical challenges in clinical trials and the benchmarks for ethical conduct of clinical research in Nigeria.

  16. Why are clinical trials necessary in India?

    Directory of Open Access Journals (Sweden)

    Subramani Poongothai

    2014-01-01

    Full Text Available Clinical trials are emerging as an important activity in India as it is an essential component of the drug discovery and development program to which India is committed. The only robust way to evaluate a new medicine is by doing properly designed clinical trials. In addition to advancing science, clinical trials offer myriad benefits to the participants. The recent hue that created in India about clinical trials is probably an exaggeration of facts. However, these points to the need for ensuring proper compliance with the regulatory norms and proper training of concerned personnel in good clinical practice (GCP. This will ensure that India continues to reap the benefits of clinical trials and also become a world leader in this field.

  17. Why are clinical trials necessary in India?

    Science.gov (United States)

    Poongothai, Subramani; Unnikrishnan, Ranjit; Balasubramanian, Jeyakumar; Nair, Mohan Damodaran; Mohan, Viswanathan

    2014-01-01

    Clinical trials are emerging as an important activity in India as it is an essential component of the drug discovery and development program to which India is committed. The only robust way to evaluate a new medicine is by doing properly designed clinical trials. In addition to advancing science, clinical trials offer myriad benefits to the participants. The recent hue that created in India about clinical trials is probably an exaggeration of facts. However, these points to the need for ensuring proper compliance with the regulatory norms and proper training of concerned personnel in good clinical practice (GCP). This will ensure that India continues to reap the benefits of clinical trials and also become a world leader in this field. PMID:24741480

  18. Ethics of clinical trials in Nigeria.

    Science.gov (United States)

    Okonta, Patrick I

    2014-05-01

    The conduct of clinical trials for the development and licensing of drugs is a very important aspect of healthcare. Drug research, development and promotion have grown to a multi-billion dollar global business. Like all areas of human endeavour involving generation and control of huge financial resources, it could be subject to deviant behaviour, sharp business practices and unethical practices. The main objective of this review is to highlight potential ethical challenges in the conduct of clinical trials in Nigeria and outline ways in which these can be avoided. Current international and national regulatory and ethical guidelines are reviewed to illustrate the requirements for ethical conduct of clinical trials. Past experiences of unethical conduct of clinical trials especially in developing countries along with the increasing globalisation of research makes it imperative that all players should be aware of the ethical challenges in clinical trials and the benchmarks for ethical conduct of clinical research in Nigeria. PMID:25013247

  19. Ethics of clinical trials in Nigeria

    Directory of Open Access Journals (Sweden)

    Patrick I Okonta

    2014-01-01

    Full Text Available The conduct of clinical trials for the development and licensing of drugs is a very important aspect of healthcare. Drug research, development and promotion have grown to a multi-billion dollar global business. Like all areas of human endeavour involving generation and control of huge financial resources, it could be subject to deviant behaviour, sharp business practices and unethical practices. The main objective of this review is to highlight potential ethical challenges in the conduct of clinical trials in Nigeria and outline ways in which these can be avoided. Current international and national regulatory and ethical guidelines are reviewed to illustrate the requirements for ethical conduct of clinical trials. Past experiences of unethical conduct of clinical trials especially in developing countries along with the increasing globalisation of research makes it imperative that all players should be aware of the ethical challenges in clinical trials and the benchmarks for ethical conduct of clinical research in Nigeria.

  20. Paperless clinical trials: Myth or reality?

    Directory of Open Access Journals (Sweden)

    Sandeep K Gupta

    2015-01-01

    Full Text Available There is an urgent need to expedite the time-to-market for new drugs and to make the approval process simpler. But clinical trials are a complex process and the increased complexity leads to decreased efficiency. Hence, pharmaceutical organizations want to move toward a more technology-driven clinical trial process for recording, analyzing, reporting, archiving, etc., In recent times, the progress has certainly been made in developing paperless systems that improve data capture and management. The adaptation of paperless processes may require major changes to existing procedures. But this is in the best interests of these organizations to remain competitive because a paperless clinical trial would lead to a consistent and streamlined framework. Moreover, all major regulatory authorities also advocate adoption of paperless trial. But challenges still remain toward implementation of paperless clinical trial process.

  1. Randomization in clinical trials: conclusions and recommendations.

    Science.gov (United States)

    Lachin, J M; Matts, J P; Wei, L J

    1988-12-01

    The statistical properties of simple (complete) randomization, permuted-block (or simply blocked) randomization, and the urn adaptive biased-coin randomization are summarized. These procedures are contrasted to covariate adaptive procedures such as minimization and to response adaptive procedures such as the play-the-winner rule. General recommendations are offered regarding the use of complete, permuted-block, or urn randomization. In a large double-masked trial, any of these procedures may be acceptable. For a given trial, the relative merits of each procedure should be carefully weighed in relation to the characteristics of the trial. Important considerations are the size of the trial, overall as well as within the smallest subgroup to be employed in a subgroup-specific analysis, whether or not the trial is to be masked, and the resources needed to perform the proper randomization-based permutational analysis. PMID:3203526

  2. Marketing and clinical trials: a case study

    Directory of Open Access Journals (Sweden)

    Entwistle Vikki A

    2007-11-01

    Full Text Available Abstract Background Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Methods Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, of 12 factors that may affect the success of the marketing and sales activities associated with clinical trials. Results The case study demonstrates that trials need various categories of people to buy in – hence, to be successful, trialists must embrace marketing strategies to some extent. Conclusion The performance of future clinical trials could be enhanced if trialists routinely considered these factors.

  3. Paperless clinical trials: Myth or reality?

    Science.gov (United States)

    Gupta, Sandeep K.

    2015-01-01

    There is an urgent need to expedite the time-to-market for new drugs and to make the approval process simpler. But clinical trials are a complex process and the increased complexity leads to decreased efficiency. Hence, pharmaceutical organizations want to move toward a more technology-driven clinical trial process for recording, analyzing, reporting, archiving, etc., In recent times, the progress has certainly been made in developing paperless systems that improve data capture and management. The adaptation of paperless processes may require major changes to existing procedures. But this is in the best interests of these organizations to remain competitive because a paperless clinical trial would lead to a consistent and streamlined framework. Moreover, all major regulatory authorities also advocate adoption of paperless trial. But challenges still remain toward implementation of paperless clinical trial process. PMID:26288464

  4. Clinical Trials | NIH MedlinePlus the Magazine

    Science.gov (United States)

    ... of this page please turn JavaScript on. Feature: Clinical Trials Clinical Trials, A Healthier Future for All Fall 2016 Table ... in was reviewed by an IRB. Find a Clinical Trial Near You Health research takes place at hospitals, ...

  5. Disclosure of investigators' recruitment performance in multicenter clinical trials

    DEFF Research Database (Denmark)

    Dal-Ré, Rafael; Moher, David; Gluud, Christian;

    2011-01-01

    Rafael Dal-Ré and colleagues argue that the recruitment targets and performance of all site investigators in multi-centre clinical trials should be disclosed in trial registration sites before a trial starts, and when it ends.......Rafael Dal-Ré and colleagues argue that the recruitment targets and performance of all site investigators in multi-centre clinical trials should be disclosed in trial registration sites before a trial starts, and when it ends....

  6. From randomised trials to rational practice.

    Science.gov (United States)

    van Gijn, J

    2005-01-01

    From the age of Enlightenment onwards, philosophical thinking has become increasingly influenced by empiricism: observations lead to theories, but experiments are needed to put the reasoning to the test. However, it was not until the middle of the 20th century that well-designed experiments were at last introduced in medical treatment, in the form of randomised controlled clinical trials. This design is now standard in medicine, but in everyday practice a multitude of management decisions must still be taken without good evidence. There are several reasons for this: there may not be a trial at all or only a single trial; trial results may be equivocal; patients may be different from those enrolled in trials; new procedures require practice, or a trial may not be feasible. 'Logical reasoning', with all its fallacies, is still required - not only to fill the gaps in empirical knowledge but also to interpret existing evidence and to plan new trials. In fact, the generation of new knowledge is a continuous, cyclical process in which newly gained insights in pathophysiology give rise to new therapeutic experiments, the results of which generate fresh hypotheses, and so on. Compassion, curiosity and doubt are the essential forces that keep the cycle moving. Conversely, the progress is slowed down by present-day legalism, which distorts investigator accountability and patient autonomy.

  7. Clinical trial registration in oral health journals.

    Science.gov (United States)

    Smaïl-Faugeron, V; Fron-Chabouis, H; Durieux, P

    2015-03-01

    Prospective registration of randomized controlled trials (RCTs) represents the best solution to reporting bias. The extent to which oral health journals have endorsed and complied with RCT registration is unknown. We identified journals publishing RCTs in dentistry, oral surgery, and medicine in the Journal Citation Reports. We classified journals into 3 groups: journals requiring or recommending trial registration, journals referring indirectly to registration, and journals providing no reference to registration. For the 5 journals with the highest 2012 impact factors in each group, we assessed whether RCTs with results published in 2013 had been registered. Of 78 journals examined, 32 (41%) required or recommended trial registration, 19 (24%) referred indirectly to registration, and 27 (35%) provided no reference to registration. We identified 317 RCTs with results published in the 15 selected journals in 2013. Overall, 73 (23%) were registered in a trial registry. Among those, 91% were registered retrospectively and 32% did not report trial registration in the published article. The proportion of trials registered was not significantly associated with editorial policies: 29% with results in journals that required or recommended registration, 15% in those that referred indirectly to registration, and 21% in those providing no reference to registration (P = 0.05). Less than one-quarter of RCTs with results published in a sample of oral health journals were registered with a public registry. Improvements are needed with respect to how journals inform and require their authors to register their trials.

  8. The Cooperative Landscape of Multinational Clinical Trials.

    Science.gov (United States)

    Hsiehchen, David; Espinoza, Magdalena; Hsieh, Antony

    2015-01-01

    The scale and nature of cooperative efforts spanning geopolitical borders in clinical research have not been elucidated to date. In a cross-sectional study of 110,428 interventional trials registered in Clinicaltrials.gov, we characterized the evolution, trial demographics, and network properties of multinational clinical research. We reveal that the relative growth of international collaboratives has remained stagnant in the last two decades, although clinical trials have evolved to become much larger in scale. Multinational clinical trials are also characterized by higher patient enrollments, industry funding, and specific clinical disciplines including oncology and infectious disease. Network analyses demonstrate temporal shifts in collaboration patterns between countries and world regions, with developing nations now collaborating more within themselves, although Europe remains the dominant contributor to multinational clinical trials worldwide. Performances in network centrality measures also highlight the differential contribution of nations in the global research network. A city-level clinical trial network analysis further demonstrates how collaborative ties decline with physical distance. This study clarifies evolving themes and highlights potential growth mechanisms and barriers in multinational clinical trials, which may be useful in evaluating the role of national and local policies in organizing transborder efforts in clinical endeavors. PMID:26103155

  9. Justifying clinical trials for porcine islet xenotransplantation.

    Science.gov (United States)

    Ellis, Cara E; Korbutt, Gregory S

    2015-01-01

    The development of the Edmonton Protocol encouraged a great deal of optimism that a cell-based cure for type I diabetes could be achieved. However, donor organ shortages prevent islet transplantation from being a widespread solution as the supply cannot possibly equal the demand. Porcine islet xenotransplantation has the potential to address these shortages, and recent preclinical and clinical trials show promising scientific support. Consequently, it is important to consider whether the current science meets the ethical requirements for moving toward clinical trials. Despite the potential risks and the scientific unknowns that remain to be investigated, there is optimism regarding the xenotransplantation of some types of tissue, and enough evidence has been gathered to ethically justify clinical trials for the most safe and advanced area of research, porcine islet transplantation. Researchers must make a concerted effort to maintain a positive image for xenotransplantation, as a few well-publicized failed trials could irrevocably damage public perception of xenotransplantation. Because all of society carries the burden of risk, it is important that the public be involved in the decision to proceed. As new information from preclinical and clinical trials develops, policy decisions should be frequently updated. If at any point evidence shows that islet xenotransplantation is unsafe, then clinical trials will no longer be justified and they should be halted. However, as of now, the expected benefit of an unlimited supply of islets, combined with adequate informed consent, justifies clinical trials for islet xenotransplantation.

  10. Function: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Shakuri Seyed Kazem

    2015-03-01

    Full Text Available Introduction: Prevention of pulmonary complications after coronary artery bypass graft is attended as a very important issue. The aim of this study was to evaluate the role of pulmonary rehabilitation before surgery for reducing the risk of pulmonary complications after surgery. Methods: In a randomized clinical trial, 60 patients undergoing heart surgery were randomly divided into two groups A and B. Chest physiotherapy was performed before and after surgery on group A patients however it was done on group B’s, only after surgery. Effects of preoperative pulmonary rehabilitation were compared between two groups, using spirometry and arterial blood gas (ABG. Results: Thirty nine males (65% and 21 females (35% with mean age of 8.10 ± 9.56 were analyzed.The mean differences were statistically significant for predicted forced vital capacity (FVC (CI95%:1.3 to 8.7 and Predicted Peak Flow indices (PEF (CI 95%: 1.9 to 9.4 of spirometry indicator,PCO2 index (of ABG parameter (CI 95%: 1.4 to 8.9 and mean oxygen saturation (mean Spo2 (CI 95%: 0.6 to 1.7 of ABG index in two groups. Conclusion: The performance of pulmonary rehabilitation program before surgery is recommended, as it may result in the reduction of complications of heart surgery.

  11. Barriers to Recruitment of Rural Patients in Cancer Clinical Trials

    OpenAIRE

    Virani, Shamsuddin; Burke, Lola; Remick, Scot C.; Abraham, Jame

    2011-01-01

    Rates of clinical trial participation are lower among patients in rural areas. Oncologists should be trained to address patient concerns regarding clinical trial availability, utility, and accessibility.

  12. Pragmatic design in randomized controlled trials.

    Science.gov (United States)

    Purgato, M; Barbui, C; Stroup, S; Adams, C

    2015-01-01

    At more than 10 years after the paper by Hotopf and colleagues regarding pragmatic trials in psychiatry, the field has evolved and is evolving further. There have been many developments in our understanding of what pragmatism really means, and excellent examples of truly pragmatic trials in psychiatry are currently available. Funders have helped encourage more emphasis on the need for such studies, but 'local' and trans-national regulations could help more. Consumers of the evidence should have a greater voice in generating the research agenda and, as this happens, the questions generated are more likely to be answered by a pragmatic approach to trials. PMID:25065958

  13. Provenance trials of larch in Siberia

    Energy Technology Data Exchange (ETDEWEB)

    Milyutin, L.I. [V.N. Sukachev Inst. of Forest SB RAS, Krasnoyarsk (Russian Federation)

    1995-12-31

    Some results of provenance trials of larch in Siberia are given. These provenance trials were established in the last thirty years by efforts of V.N. Sukaczev Inst. of Forest. Provenances and species of larch were tested in some field trials distributed over Siberia between Lat. N 52 deg and 66 deg, Long. E 88 deg and 113 deg: near Krasnoyarsk, in Republic Khakasia (an altitudes of 800 and 1200 metres), in the Lower Yenisei near Turukhansk, in the west and south regions of Krasnoyarsk territory, in the Upper Lena, near Chita. 2 refs

  14. The National Cancer Institute of Canada Clinical Trials Group MAP.3 trial: an international breast cancer prevention trial

    OpenAIRE

    Pater, J.; Richardson, H.; Johnston, D.; Goss, Paul E.

    2007-01-01

    Several large phase iii trials have demonstrated that tamoxifen—and more recently, raloxifene—can effectively reduce the incidence of invasive breast cancer by 50%. However, these selective estrogen receptor modulators can also be associated with several rare, but serious, adverse events. Recently, the third-generation aromatase inhibitors (AIS) have demonstrated excellent efficacy in adjuvant breast cancer trials, and they show particular promise in the breast cancer prevention setting. The ...

  15. African HIV/AIDS trials are more likely to report adequate allocation concealment and random generation than North American trials.

    OpenAIRE

    Nandi Siegfried; Michael Clarke; Jimmy Volmink; Lize Van der Merwe

    2008-01-01

    BACKGROUND: Adherence to good methodological quality is necessary to minimise bias in randomised conrolled trials (RCTs). Specific trial characteristics are associated with better trial quality, but no studies to date are specific to HIV/AIDS or African trials. We postulated that location may negatively impact on trial quality in regions where resources are scarce. METHODS: 1) To compare the methodological quality of all HIV/AIDS RCTs conducted in Africa with a random sample of similar trials...

  16. Is tranexamic acid effective for acute upper gastrointestinal bleeding?

    Directory of Open Access Journals (Sweden)

    Sebastián Flores

    2015-12-01

    Full Text Available La hemorragia digestiva alta corresponde a una emergencia médico-quirúrgica debido a la alta morbilidad y mortalidad que conlleva. El ácido tranexámico, un antifibrinolítico, podría ayudar a lograr un control precoz del sangrado, sin embargo existe controversia sobre su real utilidad. Utilizando la base de datos Epistemonikos, la cual es mantenida mediante búsquedas en 30 bases de datos, identificamos cinco revisiones sistemáticas que en conjunto incluyen ocho estudios aleatorizados. Realizamos un metanálisis y tablas de resumen de los resultados utilizando el método GRADE. Concluimos que el ácido tranexámico probablemente disminuye el resangrado y la mortalidad, y no aumenta los efectos adversos tromboembólicos en pacientes con hemorragia digestiva alta.

  17. POST - SURGICAL WOUND CARE IN ORTHOPEDICS: ROLE OF TRANEXAMIC ACID

    Directory of Open Access Journals (Sweden)

    Anil

    2015-04-01

    Full Text Available Post - surgical infections constitutes a major cause of morbidity and mortality in post - operative patients in orthopaedics . Most of these are hospital acquired and organisms being resistant to major antibiotics and patients are not in a condition to be discharged from hospital. The aim of the present study was to analyze the role of Tranexaemic acid in prevention of wound inf ection in post - operative patients. A total of 120 patients were taken of which 30 each were operated for spine , intertrochanteric fractures , bipolar hemiarthroplasty and general orthopaedics ( F orearm plating , distal humeral plating , philos. Age of the pat ient were taken between 18 to 65 years. Males formed about 60% of the patients. Duration from injury to surgery was 3.56 days. Two patients out of 60 on tranexaemic acid were infected whereas 4 out of 60 patients who were not given the medicine were infected. The drug proves to be also effective in reducing wound dehiscence rate , need of prolonged antibiotics and thus overall reduces the postoperative morbidity in pa tients.

  18. Is tranexamic acid effective for acute upper gastrointestinal bleeding?

    OpenAIRE

    Sebastián Flores; Carolina Avilés; Gabriel Rada

    2015-01-01

    La hemorragia digestiva alta corresponde a una emergencia médico-quirúrgica debido a la alta morbilidad y mortalidad que conlleva. El ácido tranexámico, un antifibrinolítico, podría ayudar a lograr un control precoz del sangrado, sin embargo existe controversia sobre su real utilidad. Utilizando la base de datos Epistemonikos, la cual es mantenida mediante búsquedas en 30 bases de datos, identificamos cinco revisiones sistemáticas que en conjunto incluyen ocho estudios aleatorizados. Realizam...

  19. Citicoline for ischemic stroke: ICTUS trial

    Directory of Open Access Journals (Sweden)

    Vladimir Anatolyevich Parfenov

    2012-01-01

    Full Text Available The paper gives data available in the literature on the use of citicoline in an experimental model of ischemic stroke (IS and in randomized multicenter placebo-controlled trials. It analyzes the results of the ICTUS trial in which 2298 patients with IS who received randomly citicoline or placebo for 24 hours after the onset of symptoms (I000 mg intravenously every I2 hours during the first 3 days, then orally as one 500-mg tablet every 12 hours during 6 weeks. The results of the trial confirmed the safety of citicoline used in IS, but failed to show its significant advantage over placebo in reducing the degree of disability (global improvement 90 days later. However, to pool the results of the ICTUS trial with those of other randomized multicenter placebo-controlled studies demonstrates a significant decrease in the degree of disability in IS patients treated with citicoline.

  20. Blinding in randomized clinical trials: imposed impartiality

    DEFF Research Database (Denmark)

    Hróbjartsson, A; Boutron, I

    2011-01-01

    Blinding, or "masking," is a crucial method for reducing bias in randomized clinical trials. In this paper, we review important methodological aspects of blinding, emphasizing terminology, reporting, bias mechanisms, empirical evidence, and the risk of unblinding. Theoretical considerations...

  1. Narrating the Mensalão trial

    DEFF Research Database (Denmark)

    Damgaard, Mads

    2015-01-01

    Coming to a close in the last days of 2012, the trial of the so-called mensalão network was heralded as Brazil's trial of the century. Involving corruption in the top ranks of the business world and the former government, the process ended with an exceptional result in the sense that severe...... sentences were meted out to 25 of the 38 defendants, thereby breaking an established pattern of impunity for corrupt politicians in Brazilian courts. As a scandal potentially harmful for the governing party and the former president Luis “Lula” da Silva, the eyes and spotlights of the national media were...... fixed on the trial. However, the varying and contested ways in which the case was presented by media from the outbreak of the scandal in 2005 until the end of the trial bears witness to the fact that narratives concerning corruption scandals can potentially encompass a broad range of political...

  2. Trials of electronet fencing to exclude coyotes

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — This report is on the trials of using electronet fencing to exclude coyotes for the protection of black-footed ferrets in Montana. Reintroduction of black-tailed...

  3. Survival in prostate cancer prevention trial detailed

    Science.gov (United States)

    In the NCI-sponsored Prostate Cancer Prevention Trial, initial findings from a decade ago showed that the drug finasteride significantly reduced the risk of prostate cancer, but among those who did develop prostate cancer, paradoxically, the drug was asso

  4. Smart Technology in Lung Disease Clinical Trials.

    Science.gov (United States)

    Geller, Nancy L; Kim, Dong-Yun; Tian, Xin

    2016-01-01

    This article describes the use of smart technology by investigators and patients to facilitate lung disease clinical trials and make them less costly and more efficient. By "smart technology" we include various electronic media, such as computer databases, the Internet, and mobile devices. We first describe the use of electronic health records for identifying potential subjects and then discuss electronic informed consent. We give several examples of using the Internet and mobile technology in clinical trials. Interventions have been delivered via the World Wide Web or via mobile devices, and both have been used to collect outcome data. We discuss examples of new electronic devices that recently have been introduced to collect health data. While use of smart technology in clinical trials is an exciting development, comparison with similar interventions applied in a conventional manner is still in its infancy. We discuss advantages and disadvantages of using this omnipresent, powerful tool in clinical trials, as well as directions for future research.

  5. Single Institution Feasibility Trials - Cancer Imaging Program

    Science.gov (United States)

    Within the CIP program, the current R21 mechanism provides potential funding for small, single institution feasibility trials. The current announcement is titled In Vivo Cancer Imaging Exploratory/Developmental Grants.

  6. Blinding in randomized clinical trials: imposed impartiality

    DEFF Research Database (Denmark)

    Hróbjartsson, A; Boutron, I

    2011-01-01

    Blinding, or "masking," is a crucial method for reducing bias in randomized clinical trials. In this paper, we review important methodological aspects of blinding, emphasizing terminology, reporting, bias mechanisms, empirical evidence, and the risk of unblinding. Theoretical considerations and...

  7. Nutrition Intervention Trials in Linxian, China

    Science.gov (United States)

    Randomized controlled trials were launched in 1985 to test the effects of multiple vitamin and mineral interventions on total mortality and total and cause-specific cancer mortality in a rural Chinese population

  8. Smart Technology in Lung Disease Clinical Trials.

    Science.gov (United States)

    Geller, Nancy L; Kim, Dong-Yun; Tian, Xin

    2016-01-01

    This article describes the use of smart technology by investigators and patients to facilitate lung disease clinical trials and make them less costly and more efficient. By "smart technology" we include various electronic media, such as computer databases, the Internet, and mobile devices. We first describe the use of electronic health records for identifying potential subjects and then discuss electronic informed consent. We give several examples of using the Internet and mobile technology in clinical trials. Interventions have been delivered via the World Wide Web or via mobile devices, and both have been used to collect outcome data. We discuss examples of new electronic devices that recently have been introduced to collect health data. While use of smart technology in clinical trials is an exciting development, comparison with similar interventions applied in a conventional manner is still in its infancy. We discuss advantages and disadvantages of using this omnipresent, powerful tool in clinical trials, as well as directions for future research. PMID:26135330

  9. On the scientific inference from clinical trials.

    Science.gov (United States)

    Holmberg, L; Baum, M; Adami, H O

    1999-05-01

    We have not been able to describe clearly how we generalize findings from a study to our own 'everyday patients'. This difficulty is not surprising, since generalization deals with how empirical observations are related to the growth of scientific knowledge, which is a major philosophical problem. An argument, sometimes used to discard evidence from a trial, is that the patient sample was too selected and therefore not 'representative' enough for the results to be meaningful for generalization. In this paper, we discuss issues of representativeness and generalizability. Other authors have shown that generalization cannot only depend on statistical inference. Then, how do randomized clinical trials contribute to the growth of knowledge? We discuss three aspects of the randomized clinical trial (Mant 1999), First, the trial is an empirical experiment set up to study the intervention on the question as specifically and as much in isolation from other -- biasing and confounding -- factors as possible (Rothman & Greenland 1998). Second, the trial is set up to challenge our prevailing hypotheses (or prejudices) and the trial is above all a help in error elimination (Popper 1992). Third, we need to learn to see new, unexpected and thought-provoking patterns in the data from a trial. Point one -- and partly point two -- refers to the paradigm of the controlled experiment in scientific method. How much a study contributes to our knowledge, with respect to points two and three, relates to its originality. In none of these respects is the representativeness of the patients, or the clinical situations, crucial for judging the study and its possible inferences. However, we also discuss that the biological domain of disease that was studied in a particular trial has to be taken into account. Thus, the inference drawn from a clinical study is not only a question of statistical generalization, but must include a jump from the world of experiences into the world of reason

  10. Midwest Vegetable Trial Report for 2015

    OpenAIRE

    Maynard, Elizabeth

    2016-01-01

    This is a compilation of 19 research trial reports from six land-grant universities in the midwestern United States. Crops include bok choy, cantaloupe, cucumber, pepper, pumpkin, sweet corn, squash, tomato, and watermelon. Several crops were evaluated in high tunnels or hoophouses. Most trials evaluated different cultivars or varieties, including one investigating cantaloupe variety influence on cucumber beetle presence and incidence of bacterial wilt. Four reports addressed specific growing...

  11. Reference bias in reports of drug trials.

    OpenAIRE

    Dickersin, K

    1987-01-01

    Articles published before 1985 describing double blind trials of two or more non-steroidal anti-inflammatory drugs in rheumatoid arthritis were examined to see whether there was any bias in the references they cited. Althogether 244 articles meeting the criteria were found through a Medline search and through examining the reference lists of the articles retrieved. The drugs compared in the studies were classified as new or as control drugs and the outcome of the trial as positive or not posi...

  12. Trials within trials? Researcher, funder and ethical perspectives on the practicality and acceptability of nesting trials of recruitment methods in existing primary care trials

    Directory of Open Access Journals (Sweden)

    Delaney Brendan

    2010-04-01

    Full Text Available Abstract Background Trials frequently encounter difficulties in recruitment, but evidence on effective recruitment methods in primary care is sparse. A robust test of recruitment methods involves comparing alternative methods using a randomized trial, 'nested' in an ongoing 'host' trial. There are potential scientific, logistical and ethical obstacles to such studies. Methods Telephone interviews were undertaken with four groups of stakeholders (funders, principal investigators, trial managers and ethics committee chairs to explore their views on the practicality and acceptability of undertaking nested trials of recruitment methods. These semi-structured interviews were transcribed and analysed thematically. Results Twenty people were interviewed. Respondents were familiar with recruitment difficulties in primary care and recognised the case for 'nested' studies to build an evidence base on effective recruitment strategies. However, enthusiasm for this global aim was tempered by the challenges of implementation. Challenges for host studies included increasing complexity and management burden; compatibility between the host and nested study; and the impact of the nested study on trial design and relationships with collaborators. For nested recruitment studies, there were concerns that host study investigators might have strong preferences, limiting the nested study investigators' control over their research, and also concerns about sample size which might limit statistical power. Nested studies needed to be compatible with the main trial and should be planned from the outset. Good communication and adequate resources were seen as important. Conclusions Although research on recruitment was welcomed in principle, the issue of which study had control of key decisions emerged as critical. To address this concern, it appeared important to align the interests of both host and nested studies and to reduce the burden of hosting a recruitment trial. These

  13. Trial geography, pharmacogenetics, and global drug development.

    Science.gov (United States)

    Schuck, R N; Florian, J; Charlab, R; Pacanowski, M

    2015-03-01

    Drug development is increasingly global. The benefits of multiregional trials include worldwide evaluation of safety and efficacy. However, clinical practice, environmental, and genetic factors can vary across geographic regions, significantly influencing trial outcomes within a specific geographic region or the global population relative to the United States (US). Genomic technologies and research discoveries continue to advance at a remarkable pace, offering opportunities to explore intrinsic factors that could account for regional variability in drug pharmacokinetics or response.

  14. Strength of Mock-up Trial Grout

    DEFF Research Database (Denmark)

    Sørensen, Eigil V.

    The present report describes tests carried out on samples taken and cast during the execution of a mock-up trial placement of the high performance grout MASTERFLOW 9500 on January 21, 2009.......The present report describes tests carried out on samples taken and cast during the execution of a mock-up trial placement of the high performance grout MASTERFLOW 9500 on January 21, 2009....

  15. Phase 1 Trials in Pancreatic Cancer

    Directory of Open Access Journals (Sweden)

    Esther Yu

    2014-07-01

    Full Text Available Despite many clinical trials over the last two decades since the approval of gemcitabine, the survival of patients with pancreatic cancer has improved by a few only months. This disappointing reality underlines an urgent need to develop more effective drugs or better combinations. A variety of phase I trials were presented at the annual meeting of ASCO 2014 focusing on locally advanced and metastatic pancreatic cancer. We summarize four abstracts (abstracts #4116, #4123, #4026, #4138.

  16. Randomization in substance abuse clinical trials

    OpenAIRE

    Woolson Robert F; Hedden Sarra L; Malcolm Robert J

    2006-01-01

    Abstract Background A well designed randomized clinical trial rates as the highest level of evidence for a particular intervention's efficacy. Randomization, a fundamental feature of clinical trials design, is a process invoking the use of probability to assign treatment interventions to patients. In general, randomization techniques pursue the goal of providing objectivity to the assignment of treatments, while at the same time balancing for treatment assignment totals and covariate distribu...

  17. Marketing and clinical trials: a case study

    OpenAIRE

    Entwistle Vikki A; Snowdon Claire; Garcia Jo; Knight Rosemary C; Shakur Haleema; Elbourne Diana R; Roberts Ian; Francis David; McDonald Alison M; Grant Adrian M; Campbell Marion K

    2007-01-01

    Abstract Background Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Methods Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, o...

  18. Statistical methods in recent HIV noninferiority trials: reanalysis of 11 trials.

    Directory of Open Access Journals (Sweden)

    Philippe Flandre

    Full Text Available BACKGROUND: In recent years the "noninferiority" trial has emerged as the new standard design for HIV drug development among antiretroviral patients often with a primary endpoint based on the difference in success rates between the two treatment groups. Different statistical methods have been introduced to provide confidence intervals for that difference. The main objective is to investigate whether the choice of the statistical method changes the conclusion of the trials. METHODS: We presented 11 trials published in 2010 using a difference in proportions as the primary endpoint. In these trials, 5 different statistical methods have been used to estimate such confidence intervals. The five methods are described and applied to data from the 11 trials. The noninferiority of the new treatment is not demonstrated if the prespecified noninferiority margin it includes in the confidence interval of the treatment difference. RESULTS: Results indicated that confidence intervals can be quite different according to the method used. In many situations, however, conclusions of the trials are not altered because point estimates of the treatment difference were too far from the prespecified noninferiority margins. Nevertheless, in few trials the use of different statistical methods led to different conclusions. In particular the use of "exact" methods can be very confusing. CONCLUSION: Statistical methods used to estimate confidence intervals in noninferiority trials have a strong impact on the conclusion of such trials.

  19. Internet trials: participant experiences and perspectives

    Directory of Open Access Journals (Sweden)

    Mathieu Erin

    2012-10-01

    Full Text Available Abstract Background Use of the Internet to conduct randomised controlled trials is increasing, and provides potential to increase equity of access to medical research, increase the generalisability of trial results and decrease the costs involved in conducting large scale trials. Several studies have compared response rates, completeness of data, and reliability of surveys using the Internet and traditional methods, but very little is known about participants’ attitudes towards Internet-based randomised trials or their experience of participating in an Internet-based trial. Objective To obtain insights into the experiences and perspectives of participants in an Internet-based randomised controlled trial, their attitudes to the use of the Internet to conduct medical research, and their intentions regarding future participation in Internet research. Methods All English speaking participants in a recently completed Internet randomised controlled trial were invited to participate in an online survey. Results 1246 invitations were emailed. 416 participants completed the survey between May and October 2009 (33% response rate. Reasons given for participating in the Internet RCT fell into 4 main areas: personal interest in the research question and outcome, ease of participation, an appreciation of the importance of research and altruistic reasons. Participants’ comments and reflections on their experience of participating in a fully online trial were positive and less than half of participants would have participated in the trial had it been conducted using other means of data collection. However participants identified trade-offs between the benefits and downsides of participating in Internet-based trials. The main trade-off was between flexibility and convenience – a perceived benefit – and a lack connectedness and understanding – a perceived disadvantage. The other tradeoffs were in the areas of: ease or difficulty in use of the Internet

  20. Effects of tranexamic acid impregnated gelatin sponge on postoperative bleeding after multi-segment lumbar vertebra surgery%氨甲环酸浸渍明胶海绵对腰椎手术患者术后出血的影响

    Institute of Scientific and Technical Information of China (English)

    张嘉男; 刘继军; 贺欣; 孟羿彬; 黄云飞; 吴起宁; 高林; 杨光; 郝定均

    2015-01-01

    背景:腰椎手术相关并发症的防治逐渐得到重视,但如何减少术后引流量较大导致的输血及住院时间延长鲜有报道。目的:探讨氨甲环酸(TXA)浸渍可吸收明胶海绵局部止血对腰椎多节段手术患者术后引流量及住院时间的影响。方法:本前瞻、随机对照研究纳入2013年7月至2014年12月行双节段腰椎后路减压融合术的患者80例。在关闭切口前随机将浸有氨甲环酸的明胶海绵应用于腰椎显露伤口中(试验组)或不做该止血措施(对照组)。手术均由同一主刀医师完成。比较两组术后总引流量、引流终止时间、术后住院时间、再入院人数及术后并发症。结果:共73例患者完成本研究,试验组35例,对照组38例。两组患者年龄、性别、体重指数、手术时间、术中失血量、术中输血例数、术中输血量无显著差异(P>0.05)。试验组的术后平均总引流量、引流时间及术后平均住院时间均显著少于对照组([213±127]ml vs [329±152]ml,[2.5±0.3]d vs [3.5±0.3]d,[3.1±0.7]d vs [4.1±0.7]d,P<0.05)。两组病例在出院后30 d内未出现局部用药相关的不良反应,未发现因相关并发症再入院者。结论:腰椎多节段手术中采用氨甲环酸浸渍可吸收明胶海绵止血可显著减少术后引流量,并缩短患者住院时长。%Background: The prevention and treatment of the complications of lumbar operation was gotten attention gradually. But how to reduce the postoperative wound volume of drainage and shorten the hospitalization time was reported rarely. Objective:To investigate clinical outcome of tranexamic acid (TXA) impregnated absorbable gelatin sponge for postopera-tive stop bleeding and hospitalization time in patients with surgical treatment of lumbar vertebrae. Methods: The consecutive 80 patients undergoing two-segment lumbar posterior decompression and intervertebral fusion from July

  1. Outcomes of tranexamic acid in total knee arthroplasty:a prospective randomized study%前瞻性随机对照研究全膝关节置换术中使用氨甲环酸的临床疗效

    Institute of Scientific and Technical Information of China (English)

    黄晓楠; 张勇

    2014-01-01

    目的:探讨全膝关节置换( TKA)术中使用氨甲环酸( TXA)的有效性和安全性。方法2010年3月至2013年3月,对88例(88膝)行初次TKA术的退变性骨关节炎患者进行前瞻性、随机化研究。患者随机分为使用TXA ( TXA组)和使用安慰剂(对照组)两组。 TXA组,在松止血带前15 min静脉给予15 mg/kg剂量的TXA;对照组给予等量的生理盐水。共11例失访( TXA组,5例;对照组,6例),剩下77例( TXA组,39例;对照组38例)患者纳入最终分析,对其术中失血量、术后24 h引流量、总引流量、隐性失血量、总失血量、输血量、和术后第3天血红蛋白,术后24 h D-二聚体,下肢瘀斑发生率、深静脉血栓( DVT)发生率进行评估。结果两组患者术前一般资料如年龄( t=0.390, P>0.05)、性别比(χ²=0.127, P>0.05)、合并疾病(χ²=0.142, P>0.05)等差异均无统计学意义,具有可比性。 TXA组术后24 h引流量(t =6.512, P<0.01)、总引流量(t =4.913, P <0.01)、隐性失血量(t=5.980, P<0.01)、总失血量(t=5.808, P<0.01)、24 h D-二聚体值(t=18.401, P<0.01)均明显低于对照组;TXA组术后第3天血红蛋白量明显高于对照组( t=4.815, P<0.01);TXA组和对照组分别有3例(共1200 ml)和4例(共1400 ml)患者接受异体输血( P>0.05)。 TXA组和对照组下肢远端深静脉血栓均为3例(P>0.05)。 TXA组下肢瘀斑发生率明显低于对照组(2.6%vs.18.4%,P<0.05)。结论静脉使用TXA,能够安全有效的减少TKA围手术期失血量,不增加深静脉血栓的风险。%Objective To investigate the effectiveness and safety of intraoperative usage of tranexamic acid (TXA) in total knee arthroplasty (TKA).Methods Between March 2010 and March 2013, 88 patients (88 knees) undergoing primary TKA for the treatment of

  2. Optimizing detector trials for humanitarian demining

    Science.gov (United States)

    Gaal, Mate; Baer, Sylke; Bloodworth, Thomas J.; Guelle, Dieter; Lewis, Adam M.; Mueller, Christina; Scharmach, Martina

    2004-09-01

    The performance of mine detecting instruments is embedded in the behavior of a complex system. The total reliability is always composed of the intrinsic physical detection capability of the sensor, application/environmental influences and human factors. The intrinsic capability and some application factors can be investigated in laboratory measurements. Human factors, other application factors and the overall reliability, can only be evaluated in blind field trials in which the probability of detection (PoD) and false alarm rate (FAR) are measured statistically. Both of these approaches are included in CEN Workshop Agreement CWA 14747:2003, which standardizes detector testing in Humanitarian Demining. We report here the results of a study to investigate how to optimize such testing. For efficient and statistically valid field trials, the number, types and burial depths of targets, and the number of test lanes, soil types, repetitions and operators need to be carefully chosen. Laboratory results should be used to help construct field trial protocols and also to help distinguish the different contributions to the PoD and FAR, to determine where to improve insufficient performance. In this study, four models of metal detector were tested in three field trials and in the laboratory. The repeatability of the field trials is assessed, taking into account operator training and experience. Results of the laboratory tests are compared with results of the field trials and used to construct a "modular model" of the system, as used in nondestructive testing. The conclusions are, in principle, applicable to trials of other types of sensor.

  3. Likely country of origin in publications on randomised controlled trials and controlled clinical trials during the last 60 years

    DEFF Research Database (Denmark)

    Gluud, Christian; Nikolova, Dimitrinka

    2007-01-01

    The number of publications on clinical trials is unknown as well as the countries publishing most trial reports. To try to examine these questions we performed an ecological study.......The number of publications on clinical trials is unknown as well as the countries publishing most trial reports. To try to examine these questions we performed an ecological study....

  4. The Trial of Napoleon: A Case Study for Using Mock Trials.

    Science.gov (United States)

    MacKay, Charles

    2000-01-01

    Describes a course entitled "The Trial of Napoleon Bonaparte" that focuses on a fictitious mock trial of Napoleon Bonaparte to answer the question: did Napoleon pervert or preserve the gain of the French Revolution? Discusses the strengths and weaknesses of the course. (CMK)

  5. Lung-MAP Launches: First Precision Medicine Trial From National Clinical Trials Network

    Science.gov (United States)

    A unique public-private collaboration today announced the initiation of the Lung Cancer Master Protocol (Lung-MAP) trial, a multi-drug, multi-arm, biomarker-driven clinical trial for patients with advanced squamous cell lung cancer. Squamous cell carcinom

  6. Biomarkers in T cell therapy clinical trials

    Directory of Open Access Journals (Sweden)

    Kalos Michael

    2011-08-01

    Full Text Available Abstract T cell therapy represents an emerging and promising modality for the treatment of both infectious disease and cancer. Data from recent clinical trials have highlighted the potential for this therapeutic modality to effect potent anti-tumor activity. Biomarkers, operationally defined as biological parameters measured from patients that provide information about treatment impact, play a central role in the development of novel therapeutic agents. In the absence of information about primary clinical endpoints, biomarkers can provide critical insights that allow investigators to guide the clinical development of the candidate product. In the context of cell therapy trials, the definition of biomarkers can be extended to include a description of parameters of the cell product that are important for product bioactivity. This review will focus on biomarker studies as they relate to T cell therapy trials, and more specifically: i. An overview and description of categories and classes of biomarkers that are specifically relevant to T cell therapy trials, and ii. Insights into future directions and challenges for the appropriate development of biomarkers to evaluate both product bioactivity and treatment efficacy of T cell therapy trials.

  7. Quality of clinical trials: A moving target

    Directory of Open Access Journals (Sweden)

    Arun Bhatt

    2011-01-01

    Full Text Available Quality of clinical trials depends on data integrity and subject protection. Globalization, outsourcing and increasing complexicity of clinical trials have made the target of achieving global quality challenging. The quality, as judged by regulatory inspections of the investigator sites, sponsors/contract research organizations and Institutional Review Board, has been of concern to the US Food and Drug Administration, as there has been hardly any change in frequency and nature of common deficiencies. To meet the regulatory expectations, the sponsors need to improve quality by developing systems with specific standards for each clinical trial process. The quality systems include: personnel roles and responsibilities, training, policies and procedures, quality assurance and auditing, document management, record retention, and reporting and corrective and preventive action. With an objective to improve quality, the FDA has planned new inspection approaches such as risk-based inspections, surveillance inspections, real-time oversight, and audit of sponsor quality systems. The FDA has partnered with Duke University for Clinical Trials Transformation Initiative, which will conduct research projects on design principles, data quality and quantity including monitoring, study start-up, and adverse event reporting. These recent initiatives will go a long way in improving quality of clinical trials.

  8. Quantitative Imaging in Cancer Clinical Trials.

    Science.gov (United States)

    Yankeelov, Thomas E; Mankoff, David A; Schwartz, Lawrence H; Lieberman, Frank S; Buatti, John M; Mountz, James M; Erickson, Bradley J; Fennessy, Fiona M M; Huang, Wei; Kalpathy-Cramer, Jayashree; Wahl, Richard L; Linden, Hannah M; Kinahan, Paul E; Zhao, Binsheng; Hylton, Nola M; Gillies, Robert J; Clarke, Laurence; Nordstrom, Robert; Rubin, Daniel L

    2016-01-15

    As anticancer therapies designed to target specific molecular pathways have been developed, it has become critical to develop methods to assess the response induced by such agents. Although traditional, anatomic CT, and MRI examinations are useful in many settings, increasing evidence suggests that these methods cannot answer the fundamental biologic and physiologic questions essential for assessment and, eventually, prediction of treatment response in the clinical trial setting, especially in the critical period soon after treatment is initiated. To optimally apply advances in quantitative imaging methods to trials of targeted cancer therapy, new infrastructure improvements are needed that incorporate these emerging techniques into the settings where they are most likely to have impact. In this review, we first elucidate the needs for therapeutic response assessment in the era of molecularly targeted therapy and describe how quantitative imaging can most effectively provide scientifically and clinically relevant data. We then describe the tools and methods required to apply quantitative imaging and provide concrete examples of work making these advances practically available for routine application in clinical trials. We conclude by proposing strategies to surmount barriers to wider incorporation of these quantitative imaging methods into clinical trials and, eventually, clinical practice. Our goal is to encourage and guide the oncology community to deploy standardized quantitative imaging techniques in clinical trials to further personalize care for cancer patients and to provide a more efficient path for the development of improved targeted therapies.

  9. Using e-technologies in clinical trials.

    Science.gov (United States)

    Rosa, Carmen; Campbell, Aimee N C; Miele, Gloria M; Brunner, Meg; Winstanley, Erin L

    2015-11-01

    Clinical trials have been slow to incorporate e-technology (digital and electronic technology that utilizes mobile devices or the Internet) into the design and execution of studies. In the meantime, individuals and corporations are relying more on electronic platforms and most have incorporated such technology into their daily lives. This paper provides a general overview of the use of e-technologies in clinical trials research, specifically within the last decade, marked by rapid growth of mobile and Internet-based tools. Benefits of and challenges to the use of e-technologies in data collection, recruitment and retention, delivery of interventions, and dissemination are provided, as well as a description of the current status of regulatory oversight of e-technologies in clinical trials research. As an example of ways in which e-technologies can be used for intervention delivery, a summary of e-technologies for treatment of substance use disorders is presented. Using e-technologies to design and implement clinical trials has the potential to reach a wide audience, making trials more efficient while also reducing costs; however, researchers should be cautious when adopting these tools given the many challenges in using new technologies, as well as threats to participant privacy/confidentiality. Challenges of using e-technologies can be overcome with careful planning, useful partnerships, and forethought. The role of web- and smartphone-based applications is expanding, and the increasing use of those platforms by scientists and the public alike make them tools that cannot be ignored.

  10. Flaw detection trial using virtual ultrasonic testing

    Energy Technology Data Exchange (ETDEWEB)

    Sarkimo, M. (VTT Technical Research Centre of Finland, Espoo (Finland))

    2010-05-15

    This report presents features of ultrasonic simulation and aspects to be considered in virtual inspection trials. A simulation trial implementation and results are reported, with main purpose to test different features of the selected simulation software in creation and analysis of a virtual detectability trial. A series of simulations was conducted using simple test block geometry that included notch shaped flaws with varying depths. To make the case realistic, significant structural noise and moderate attenuation were added to the simulation using the material properties settings. The simulation was run using different probe frequency values and crystal dimensions to produce variation in the flaw detectability.The simulated ultrasonic inspection data was analyzed using analysis tools of the used software. The signal-to-noise ratios and locations of the detected indications were characterized and detectability dependence on the notch height was assessed. Also, study about signal-to-noise ratios measured from the detected indications was performed. (orig.)

  11. Franz Kafka's The Trial: guilty or innocent?

    Science.gov (United States)

    Siegel, E

    1996-07-01

    Through an examination of The Trial by Kafka I attempt to show that the depiction of the Court apparatus is dynamically related to the commission of unconscious crimes of the type we encounter in our patients. To provide a context for the novel, I discuss Kafka's biography and some possible unconscious motivations. My goal is to show how the concept of a particular type of superego pressure can be used to understand the subtle irony in The Trial. Although Joseph K.'s behavior frequently involves oedipal crimes, there are many preoedipal themes that help account for his experience of the Court. I contrast this psychoanalytic understanding of K.'s guilt with that of literary critics who interpret The Trial as an allegory of guilt but who minimize the psychological dimensions.

  12. Developments in statistical evaluation of clinical trials

    CERN Document Server

    Oud, Johan; Ghidey, Wendimagegn

    2014-01-01

    This book describes various ways of approaching and interpreting the data produced by clinical trial studies, with a special emphasis on the essential role that biostatistics plays in clinical trials. Over the past few decades the role of statistics in the evaluation and interpretation of clinical data has become of paramount importance. As a result the standards of clinical study design, conduct and interpretation have undergone substantial improvement. The book includes 18 carefully reviewed chapters on recent developments in clinical trials and their statistical evaluation, with each chapter providing one or more examples involving typical data sets, enabling readers to apply the proposed procedures. The chapters employ a uniform style to enhance comparability between the approaches.

  13. The Hawthorne Effect: a randomised, controlled trial

    Directory of Open Access Journals (Sweden)

    van Haselen Robbert

    2007-07-01

    Full Text Available Abstract Background The 'Hawthorne Effect' may be an important factor affecting the generalisability of clinical research to routine practice, but has been little studied. Hawthorne Effects have been reported in previous clinical trials in dementia but to our knowledge, no attempt has been made to quantify them. Our aim was to compare minimal follow-up to intensive follow-up in participants in a placebo controlled trial of Ginkgo biloba for treating mild-moderate dementia. Methods Participants in a dementia trial were randomised to intensive follow-up (with comprehensive assessment visits at baseline and two, four and six months post randomisation or minimal follow-up (with an abbreviated assessment at baseline and a full assessment at six months. Our primary outcomes were cognitive functioning (ADAS-Cog and participant and carer-rated quality of life (QOL-AD. Results We recruited 176 participants, mainly through general practices. The main analysis was based on Intention to treat (ITT, with available data. In the ANCOVA model with baseline score as a co-variate, follow-up group had a significant effect on outcome at six months on the ADAS-Cog score (n = 140; mean difference = -2.018; 95%CI -3.914, -0.121; p = 0.037 favouring the intensive follow-up group, and on participant-rated quality of life score (n = 142; mean difference = -1.382; 95%CI -2.642, -0.122; p = 0.032 favouring minimal follow-up group. There was no significant difference on carer quality of life. Conclusion We found that more intensive follow-up of individuals in a placebo-controlled clinical trial of Ginkgo biloba for treating mild-moderate dementia resulted in a better outcome than minimal follow-up, as measured by their cognitive functioning. Trial registration Current controlled trials: ISRCTN45577048

  14. Clinical trials in neonates: ethical issues

    OpenAIRE

    Allmark, P. J.; Spedding, M.

    2007-01-01

    Clinical trials in neonatology often raise complex ethical problems. This paper suggests that in tackling these it is useful to identify and separate out those elements of the problem that are genuinely ethical (e.g. can I enter a child into a trial if I am not in personal equipoise?) from those that are empirical (e.g. what is the evidence for a treatment's effectiveness?) and those that are formal (e.g. what do codes or the law permit?) The genuinely ethical elements are examples of philo...

  15. Clinical Research Methodology 3: Randomized Controlled Trials.

    Science.gov (United States)

    Sessler, Daniel I; Imrey, Peter B

    2015-10-01

    Randomized assignment of treatment excludes reverse causation and selection bias and, in sufficiently large studies, effectively prevents confounding. Well-implemented blinding prevents measurement bias. Studies that include these protections are called randomized, blinded clinical trials and, when conducted with sufficient numbers of patients, provide the most valid results. Although conceptually straightforward, design of clinical trials requires thoughtful trade-offs among competing approaches-all of which influence the number of patients required, enrollment time, internal and external validity, ability to evaluate interactions among treatments, and cost.

  16. Photovoltaic domestic field trial. Third annual report

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2005-07-01

    An update on a photovoltaics field trial that has been running for four years is presented. The PV Domestic Field Trial was set up to use the design, construction, performance and monitoring of PV units to generate data for utilities, builders and other current and potential users of PVs. Subjects covered were appearance of the systems, architectural integration, fixing methods, cost effectiveness, opinions of users, monitoring and results. During the past 12 months, most of the human effort has gone into collation of data from 22 of the 28 projects. The study was sponsored by Great Britain's DTI.

  17. Clinical Trials and their Impact on Society

    Directory of Open Access Journals (Sweden)

    Olga Lidia Cuevas Pérez

    2016-02-01

    Full Text Available Today there are countless examples that illustrate the nature of technoscience, including biotechnology and pharmacology. The clinical trial is the appropriate methodology used by clinical pharmacology to test the efficacy and safety of a treatment or intervention in humans. It constitutes the cornerstone of research. Once the preclinical research is completed, one of the biggest challenges currently facing the Cuban Pharmaceutical and Biotechnological Industry is precisely the clinical evaluation. Therefore, this work aims to provide a reflection on the most significant aspects of clinical trials and their impact on society.

  18. Clinical Trials in Male Hormonal Contraception

    Directory of Open Access Journals (Sweden)

    Nieschlag E

    2011-01-01

    Full Text Available Research has established the principle of hormonal male contraception based on suppression of gonadotropins and spermatogenesis. All hormonal male contraceptives use testosterone, but only in East Asian men can testosterone alone suppress spermatogenesis to a level compatible with contraceptive protection. In Caucasians, additional agents are required of which progestins are favored. Clinical trials concentrate on testosterone combined with norethisterone, desogestrel, etonogestrel or depot-medroxyprogesterone acetate. The first randomized, placebo-controlled clinical trial performed by the pharmaceutical industry demonstrated the effectiveness of a combination of testosterone undecanoate and etonogestrel in suppressing spermatogenesis in volunteers.

  19. Differences in trial knowledge and motives for participation among cancer patients in phase 3 clinical trials.

    Science.gov (United States)

    Godskesen, T M; Kihlbom, U; Nordin, K; Silén, M; Nygren, P

    2016-05-01

    While participants in clinical oncology trials are essential for the advancement of cancer therapies, factors decisive for patient participation have been described but need further investigation, particularly in the case of phase 3 studies. The aim of this study was to investigate differences in trial knowledge and motives for participation in phase 3 clinical cancer trials in relation to gender, age, education levels and former trial experience. The results of a questionnaire returned from 88 of 96 patients (92%) were analysed using the Mann-Whitney U-test. There were small, barely relevant differences in trial knowledge among patients when stratified by gender, age or education. Participants with former trial experience were less aware about the right to withdraw. Male participants and those aged ≥65 years were significantly more motivated by a feeling of duty, or by the opinions of close ones. Men seem more motivated than women by external factors. With the awareness that elderly and single male participants might be a vulnerable group and participants with former trial experience are less likely to be sufficiently informed, the information consent process should focus more on these patients. We conclude that the informed consent process seems to work well, with good results within most subgroups. PMID:25904313

  20. Trial-to-trial reoptimization of motor behavior due to changes in task demands is limited.

    Directory of Open Access Journals (Sweden)

    Orban de Xivry J-J

    Full Text Available Each task requires a specific motor behavior that is tuned to task demands. For instance, writing requires a lot of accuracy while clapping does not. It is known that the brain adjusts the motor behavior to different task demands as predicted by optimal control theory. In this study, the mechanism of this reoptimization process is investigated by varying the accuracy demands of a reaching task. In this task, the width of the reaching target (0.5 or 8 cm was varied either on a trial-to-trial basis (random schedule or in blocks (blocked schedule. On some trials, the hand of the subjects was clamped to a rectilinear trajectory that ended 2 cm on the left or right of the target center. The rejection of this perturbation largely varied with target width in the blocked schedule but not in the random schedule. That is, subjects exhibited different motor behavior in the different schedules despite identical accuracy demands. Therefore, while reoptimization has been considered immediate and automatic, the differences in motor behavior observed across schedules suggest that the reoptimization of the motor behavior is neither happening on a trial-by-trial basis nor obligatory. The absence of trial-to-trial mechanisms, the inability of the brain to adapt to two conflicting task demands and the existence of a switching cost are discussed as possible sources of the non-optimality of motor behavior during the random schedule.

  1. Economic evaluation alongside pragmatic randomised trials: developing a standard operating procedure for clinical trials units

    Directory of Open Access Journals (Sweden)

    Russell Ian T

    2008-11-01

    Full Text Available Abstract Background There is wide recognition that pragmatic randomised trials are the best vehicle for economic evaluation. This is because trials provide the best chance of ensuring internal validity, not least through the rigorous prospective collection of patient-specific data. Furthermore the marginal cost of collecting economic data alongside clinical data is typically modest. UK Clinical Research Collaboration (UKCRC does not require a standard operating procedure (SOP for economic evaluation as a prerequisite for trial unit registration. We judge that such a SOP facilitates the integration of health economics into trials. Methods A collaboration between health economists and trialists at Bangor University led to the development of a SOP for economic evaluation alongside pragmatic trials, in addition to the twenty SOPs required by UKCRC for registration, which include randomisation, data management and statistical analysis. Results Our recent telephone survey suggests that no other UKCRC-registered trials unit currently has an economic SOP. Conclusion We argue that UKCRC should require, from all Trials Units undertaking economic evaluation and seeking registration or re-registration, a SOP for economic evaluation as one of their portfolio of supporting SOPs.

  2. OARSI Clinical Trials Recommendations: Design and conduct of clinical trials for hand osteoarthritis.

    Science.gov (United States)

    Kloppenburg, M; Maheu, E; Kraus, V B; Cicuttini, F; Doherty, M; Dreiser, R-L; Henrotin, Y; Jiang, G-L; Mandl, L; Martel-Pelletier, J; Nelson, A E; Neogi, T; Pelletier, J-P; Punzi, L; Ramonda, R; Simon, L S; Wang, S

    2015-05-01

    Hand osteoarthritis (OA) is a very frequent disease, but yet understudied. However, a lot of works have been published in the past 10 years, and much has been done to better understand its clinical course and structural progression. Despite this new knowledge, few therapeutic trials have been conducted in hand OA. The last OARSI recommendations for the conduct of clinical trials in hand OA dates back to 2006. The present recommendations aimed at updating previous recommendations, by incorporating new data. The purpose of this expert opinion, consensus driven exercise is to provide evidence-based guidance on the design, execution and analysis of clinical trials in hand OA, where published evidence is available, supplemented by expert opinion, where evidence is lacking, to perform clinical trials in hand OA, both for symptom and for structure-modification. They indicate core outcome measurement sets for studies in hand OA, and list the methods and instruments that should be used to measure symptoms or structure. For both symptom- and structure-modification, at least pain, physical function, patient global assessment, HR-QoL, joint activity and hand strength should be assessed. In addition, for structure-modification trials, structural progression should be measured by radiographic changes. We also provide a research agenda listing many unsolved issues that seem to most urgently need to be addressed from the perspective of performing "good" clinical trials in hand OA. These updated OARSI recommendations should allow for better standardizing the conduct of clinical trials in hand OA in the next future.

  3. بررسی تاثیر اسفنج ژلاتینی و شستن دهان با Tranexamic acid در جلوگیری از خونریزی پس از کشیدن دندان، در بیماران مصرف کننده وارفارین

    Directory of Open Access Journals (Sweden)

    علی پیمانی مجاور

    2011-03-01

    نتیجه‏گیری:در بیماران مصرف‏کننده وارفارین نیازی به قطع وارفارین یا کاهش دوز آن نیست. استفاده از 8/4% Tranexamic acid به عنوان هموستاز موضعی بدون استفاده از بخیه موثر می‏باشد.

  4. Electronic Cigarette Trial and Use among Young Adults: Reasons for Trial and Cessation of Vaping

    OpenAIRE

    Lois Biener; Eunyoung Song; Sutfin, Erin L.; John Spangler; Mark Wolfson

    2015-01-01

    This paper identifies predictors of trial and current use, and reasons for trying and ceasing use of electronic cigarettes (e-cigarettes) among young adults, with particular attention to former and never smokers. Data are from a mail survey of a population-based sample of adults aged 18 to 35 (N = 4740) in three U.S. metropolitan areas. Survey items assessed trial and use of e-cigarettes, cigarette smoking status, and reasons for trial and for ceasing use of e-cigarettes. Almost 23% reported ...

  5. Unit: Petroleum, Inspection Pack, National Trial Print.

    Science.gov (United States)

    Australian Science Education Project, Toorak, Victoria.

    This is a National Trial Print of a unit on petroleum developed for the Australian Science Education Project. The package contains the teacher's edition of the written material and a script for a film entitled "The Extraordinary Experience of Nicholas Nodwell" emphasizing the uses of petroleum and petroleum products in daily life and designed to…

  6. Building data quality into clinical trials.

    Science.gov (United States)

    Crerand, William J; Lamb, Jana; Rulon, Vera; Karal, Bilun; Mardekian, Jack

    2002-01-01

    Meaningful data begin with the collection process. Pharmaceutical companies are using several different strategies in clinical trials to ensure the highest quality of data. This article will examine these approaches, with an emphasis on case report form development through database release. PMID:12432815

  7. Applied Behavior Analysis: Beyond Discrete Trial Teaching

    Science.gov (United States)

    Steege, Mark W.; Mace, F. Charles; Perry, Lora; Longenecker, Harold

    2007-01-01

    We discuss the problem of autism-specific special education programs representing themselves as Applied Behavior Analysis (ABA) programs when the only ABA intervention employed is Discrete Trial Teaching (DTT), and often for limited portions of the school day. Although DTT has many advantages to recommend its use, it is not well suited to teach…

  8. Randomized controlled trials of COX-2 inhibitors

    DEFF Research Database (Denmark)

    Stefansdottir, Gudrun; De Bruin, Marie L; Knol, Mirjam J;

    2011-01-01

    BACKGROUND: Naproxen, ibuprofen and diclofenac are frequently used as comparators in randomized controlled trials (RCTs) on the safety and efficacy of cyclooxygenase (COX)-2 inhibitors. Different comparator doses may influence the results of RCTs. It has been hypothesized that RCTs of COX-2...

  9. Stroke Prevention Trials in Sickle Cell Anemia

    Directory of Open Access Journals (Sweden)

    J Gordon Millichap

    2006-06-01

    Full Text Available As part of an International Pediatric Stroke Study launched in 2002, the Stroke Prevention Trial in Sickle Cell Anemia (STOP reports a reduction in the number of overt clinical strokes in children with critically high transcranial Doppler velocities (>200 cm/sec who were regularly transfused.

  10. Clinical Trials in Male Hormonal Contraception

    OpenAIRE

    Nieschlag E

    2011-01-01

    Research has established the principle of hormonal male contraception based on suppression of gonadotropins and spermatogenesis. All hormonal male contraceptives use testosterone, but only in East Asian men can testosterone alone suppress spermatogenesis to a level compatible with contraceptive protection. In Caucasians, additional agents are required of which progestins are favored. Clinical trials concentrate on testosterone combined with norethisterone, desogestrel, etonogestrel or depo...

  11. Placebo-Controlled Trials, Ethics of

    NARCIS (Netherlands)

    van der Graaf, R; Rid, Annette

    2015-01-01

    There are often good scientific and ethical reasons for using placebo controls in clinical trials. At the same time placebo use is controversial, especially when an established effective treatment is being withheld from the control group. This article gives an overview of the key ethical positions i

  12. WP6 - Application Integration, Trials and Evaluation

    DEFF Research Database (Denmark)

    Prasad, Neeli R.; Cetin, Bilge Kartal; Moran, Humberto;

    2009-01-01

    This deliverable contains all the details on the planning, description of business cases, business goals stakeholders, IT infrastructure, evaluation guidelines and other aspects of the pilot trials, that are envisioned for demonstrating the benefits of the ASPIRE middleware platform. These pilot ...

  13. The Moral Trial: On Ethics and Economics

    NARCIS (Netherlands)

    A. Lanteri (Alessandro)

    2008-01-01

    textabstractThis dissertation investigates the experimental evidence exposing how economists’ behaviour differs from that of non-economists, in that economists display more self-interested conduct. A veritable Moral Trial has stemmed from that evidence, in which it is argued that economists are self

  14. Ethical issues in postauthorization drug trials

    NARCIS (Netherlands)

    Bernabe, R.D.L.C.

    2013-01-01

    This thesis is an attempt to raise some ethical issues that are specific to phase IV drug trials and to provide preliminary responses to such issues. We limited ourselves to issues of informed consent, risk-benefit assessment, and the therapeutic orientation of phase IV. On the issue of informed con

  15. Gone fishing in a fluid trial

    DEFF Research Database (Denmark)

    Hjortrup, Peter B; Haase, Nicolai; Wetterslev, Jørn;

    2016-01-01

    OBJECTIVE: To maximise the yield of existing data by assessing the effect on mortality of being born under the zodiac sign Pisces in a trial of intravenous (IV) fluids. DESIGN, SETTING AND PARTICIPANTS: A retrospective observational study, with no predefined hypothesis or statistical analysis pla...

  16. Blast densification trials for oilsands tailings

    Energy Technology Data Exchange (ETDEWEB)

    Port, A. [Klohn Crippen Berger Ltd., Vancouver, BC (Canada); Martens, S. [Klohn Crippen Berger Ltd., Calgary, AB (Canada); Eaton, T. [Shell Canada Ltd., Calgary, AB (Canada)

    2010-07-01

    The Shell Canada Muskeg River Mine External Tailings Facility (ETF) is an upstream constructed tailings facility located near Fort McMurray, Alberta. Raises have incrementally stepped out over the beach since construction of the starter dam and deposition within standing water has left some parts of the beach in a loose state. In order to assess the effectiveness of blast densification, a blast densification trial program that was conducted in 2006 at the ETF. The primary purpose of the test program was to determine the effectiveness of blast densification in tailings containing layers and zones of bitumen. The paper described the site characterization and explosive compaction trial program, with particular reference to test layout; drilling methodology; and blasting and timing sequence. The paper also described the instrumentation, including the seismographs; high pressure electric piezometers; low pressure electric piezometers; vibrating wire piezometers; inclinometers; settlement gauges; and surveys. Trial observations and post-trial observations were also presented. It was concluded that controlled blasting techniques could be used to safely induce liquefaction in localized areas within the tailings deposit, with a resulting increase in the tailings density. 5 refs., 1 tab., 14 figs.

  17. New EORTC clinical trials for BNCT

    International Nuclear Information System (INIS)

    Due to ethical reasons, a separated optimization of the two components of BNCT in the frame of clinical investigations can only be performed applying the whole binary system. The ongoing trial at HFR (High Flux Reactor Petten) has proven the feasibility of BNCT under defined conditions. On that basis the European Commission supported a comprehensive research project on boron imaging including three further clinical studies. In the first trial the boron uptake related to the blood boron concentration and surrounding normal tissue in various solid tumours will be examined using BSH (Sodiumborocaptate), BPA (Boronophenylalanine) or both in order to explore tumour entities, which may gain benefit from BNCT. The major objectives of the second trial are to define the maximum tolerated single and cumulative dose, and the dose limiting toxicity of BSH. The third clinical trial, a phase II study is designed to evaluate the anti-tumour effect of fractionated BNCT at the Petten treatment facility against cerebral metastasis of malignant melanoma using BPA. (author)

  18. Trial access to Cambridge University Press ebooks

    CERN Multimedia

    CERN Library

    2011-01-01

    From 1 August till 31 October, CERN users are invited to enjoy a trial access to all Cambridge University Press electronic books: http://ebooks.cambridge.org/. Please don't hesitate to send feedback to library.desk@cern.ch.

  19. Pipeline Decommissioning Trial AWE Berkshire UK - 13619

    Energy Technology Data Exchange (ETDEWEB)

    Agnew, Kieran [AWE, Aldermaston, Reading, RG7 4PR (United Kingdom)

    2013-07-01

    This Paper details the implementation of a 'Decommissioning Trial' to assess the feasibility of decommissioning the redundant pipeline operated by AWE located in Berkshire UK. The paper also presents the tool box of decommissioning techniques that were developed during the decommissioning trial. Constructed in the 1950's and operated until 2005, AWE used a pipeline for the authorised discharge of treated effluent. Now redundant, the pipeline is under a care and surveillance regime awaiting decommissioning. The pipeline is some 18.5 km in length and extends from AWE site to the River Thames. Along its route the pipeline passes along and under several major roads, railway lines and rivers as well as travelling through woodland, agricultural land and residential areas. Currently under care and surveillance AWE is considering a number of options for decommissioning the pipeline. One option is to remove the pipeline. In order to assist option evaluation and assess the feasibility of removing the pipeline a decommissioning trial was undertaken and sections of the pipeline were removed within the AWE site. The objectives of the decommissioning trial were to: - Demonstrate to stakeholders that the pipeline can be removed safely, securely and cleanly - Develop a 'tool box' of methods that could be deployed to remove the pipeline - Replicate the conditions and environments encountered along the route of the pipeline The onsite trial was also designed to replicate the physical prevailing conditions and constraints encountered along the remainder of its route i.e. working along a narrow corridor, working in close proximity to roads, working in proximity to above ground and underground services (e.g. Gas, Water, Electricity). By undertaking the decommissioning trial AWE have successfully demonstrated the pipeline can be decommissioned in a safe, secure and clean manor and have developed a tool box of decommissioning techniques. The tool box of includes

  20. Pipeline Decommissioning Trial AWE Berkshire UK - 13619

    International Nuclear Information System (INIS)

    This Paper details the implementation of a 'Decommissioning Trial' to assess the feasibility of decommissioning the redundant pipeline operated by AWE located in Berkshire UK. The paper also presents the tool box of decommissioning techniques that were developed during the decommissioning trial. Constructed in the 1950's and operated until 2005, AWE used a pipeline for the authorised discharge of treated effluent. Now redundant, the pipeline is under a care and surveillance regime awaiting decommissioning. The pipeline is some 18.5 km in length and extends from AWE site to the River Thames. Along its route the pipeline passes along and under several major roads, railway lines and rivers as well as travelling through woodland, agricultural land and residential areas. Currently under care and surveillance AWE is considering a number of options for decommissioning the pipeline. One option is to remove the pipeline. In order to assist option evaluation and assess the feasibility of removing the pipeline a decommissioning trial was undertaken and sections of the pipeline were removed within the AWE site. The objectives of the decommissioning trial were to: - Demonstrate to stakeholders that the pipeline can be removed safely, securely and cleanly - Develop a 'tool box' of methods that could be deployed to remove the pipeline - Replicate the conditions and environments encountered along the route of the pipeline The onsite trial was also designed to replicate the physical prevailing conditions and constraints encountered along the remainder of its route i.e. working along a narrow corridor, working in close proximity to roads, working in proximity to above ground and underground services (e.g. Gas, Water, Electricity). By undertaking the decommissioning trial AWE have successfully demonstrated the pipeline can be decommissioned in a safe, secure and clean manor and have developed a tool box of decommissioning techniques. The tool box of includes; - Hot tapping - a method

  1. ADEPT - Abnormal Doppler Enteral Prescription Trial

    Directory of Open Access Journals (Sweden)

    McCormick Kenny

    2009-10-01

    Full Text Available Abstract Background Pregnancies complicated by abnormal umbilical artery Doppler blood flow patterns often result in the baby being born both preterm and growth-restricted. These babies are at high risk of milk intolerance and necrotising enterocolitis, as well as post-natal growth failure, and there is no clinical consensus about how best to feed them. Policies of both early milk feeding and late milk feeding are widely used. This randomised controlled trial aims to determine whether a policy of early initiation of milk feeds is beneficial compared with late initiation. Optimising neonatal feeding for this group of babies may have long-term health implications and if either of these policies is shown to be beneficial it can be immediately adopted into clinical practice. Methods and Design Babies with gestational age below 35 weeks, and with birth weight below 10th centile for gestational age, will be randomly allocated to an "early" or "late" enteral feeding regimen, commencing milk feeds on day 2 and day 6 after birth, respectively. Feeds will be gradually increased over 9-13 days (depending on gestational age using a schedule derived from those used in hospitals in the Eastern and South Western Regions of England, based on surveys of feeding practice. Primary outcome measures are time to establish full enteral feeding and necrotising enterocolitis; secondary outcomes include sepsis and growth. The target sample size is 400 babies. This sample size is large enough to detect a clinically meaningful difference of 3 days in time to establish full enteral feeds between the two feeding policies, with 90% power and a 5% 2-sided significance level. Initial recruitment period was 24 months, subsequently extended to 38 months. Discussion There is limited evidence from randomised controlled trials on which to base decisions regarding feeding policy in high risk preterm infants. This multicentre trial will help to guide clinical practice and may also

  2. Randomized controlled trial of adjuvant oral dexamethasone pulse therapy in pemphigus vulgaris - PEMPULS trial

    NARCIS (Netherlands)

    Mentink, LF; Mackenzie, MW; Toth, GG; Laseur, M; Lambert, FPG; Veeger, NJGM; Cianchini, G; Pavlovic, MD; Jonkman, MF

    2006-01-01

    Objective: To determine the therapeutic effect of adjuvant dexamethasone pulse therapy when given in addition to conventional treatment of pemphigus vulgaris. Design: A randomized, placebo-controlled trial. Setting: International European, multicenter outpatient and inpatient study. Patients: Of the

  3. Economic evaluation alongside pragmatic randomised trials: developing a standard operating procedure for clinical trials units

    OpenAIRE

    Russell Ian T; Linck Pat; Hounsome Barry; Edwards Rhiannon T

    2008-01-01

    Abstract Background There is wide recognition that pragmatic randomised trials are the best vehicle for economic evaluation. This is because trials provide the best chance of ensuring internal validity, not least through the rigorous prospective collection of patient-specific data. Furthermore the marginal cost of collecting economic data alongside clinical data is typically modest. UK Clinical Research Collaboration (UKCRC) does not require a standard operating procedure (SOP) for economic e...

  4. Use of crowdsourcing for cancer clinical trial development.

    Science.gov (United States)

    Leiter, Amanda; Sablinski, Tomasz; Diefenbach, Michael; Foster, Marc; Greenberg, Alex; Holland, John; Oh, William K; Galsky, Matthew D

    2014-10-01

    Patient and physician awareness and acceptance of trials and patient ineligibility are major cancer clinical trial accrual barriers. Yet, trials are typically conceived and designed by small teams of researchers with limited patient input. We hypothesized that through crowdsourcing, the intellectual and creative capacity of a large number of researchers, clinicians, and patients could be harnessed to improve the clinical trial design process. In this study, we evaluated the feasibility and utility of using an internet-based crowdsourcing platform to inform the design of a clinical trial exploring an antidiabetic drug, metformin, in prostate cancer. Over a six-week period, crowd-sourced input was collected from 60 physicians/researchers and 42 patients/advocates leading to several major (eg, eligibility) and minor modifications to the clinical trial protocol as originally designed. Crowdsourcing clinical trial design is feasible, adds value to the protocol development process, and may ultimately improve the efficiency of trial conduct.

  5. Most Breast Cancer Screening Trials Have a Flawed Design

    OpenAIRE

    Gurnani, Nishant; Srivastava, Anurag

    2011-01-01

    In the present article, we discuss that why most breast cancer screening trials have a flawed origin. We suggest some solutions to correct these flaws so that more valid and reliable screening trials can be conducted in the future.

  6. Ambulatory Pessary Trial Unmasks Occult Stress Urinary Incontinence

    Directory of Open Access Journals (Sweden)

    Bilal Chughtai

    2012-01-01

    Conclusion. An ambulatory pessary trial is an effective, easy, and inexpensive method to approximate anatomic results achieved by surgery under real-life conditions. In our series, 20% of patients with occult SUI were identified by pessary trial alone.

  7. Prostate Cancer Research Trial Helps John Spencer Treat His Cancer

    Science.gov (United States)

    ... this page please turn Javascript on. Feature: Prostate Cancer Prostate Cancer Research Trial Helps John Spencer Treat His ... Read More "Prostate Cancer" Articles Progress Against Prostate Cancer / Prostate Cancer Research Trial Helps John Spencer Treat His ...

  8. Single-trial normalization for event-related spectral decomposition reduces sensitivity to noisy trials

    Directory of Open Access Journals (Sweden)

    Romain eGrandchamp

    2011-09-01

    Full Text Available In EEG research, the classical Event-Related Potential (ERP model often proves to be a limited method when studying complex brain dynamics. For this reason, spectral techniques adapted from signal processing such as Event-Related Spectral Perturbation (ERSP – and its variant ERS (Event-Related Synchronization and ERD (Event-Related Desynchronization – have been used over the past 20-years. They represent average spectral changes in response to a stimulus.These spectral methods do not have strong consensus for comparing pre and post-stimulus activity. When computing ERSP, pre-stimulus baseline removal is usually performed after averaging the spectral estimate of multiple trials. Correcting the baseline of each single-trial prior to averaging spectral estimates is an alternative baseline correction method. However, we show that this method leads to positively skewed post-stimulus ERSP values. We eventually present new single-trial based ERSP baseline correction methods that perform trial normalization or centering prior to applying classical baseline correction methods. We show that single-trial correction methods minimize the contribution of artifactual data trials with high-amplitude spectral estimates and are robust to outliers when performing statistical inference testing. We then characterize these methods in terms of their time-frequency responses and behavior when performing statistical inference testing compared to classical ERSP methods.

  9. Continental cement trial burn strategy follow-up

    Energy Technology Data Exchange (ETDEWEB)

    Woodford, J. [Gossman Consulting, Inc., Springboro, OH (United States); Winders, H. [Continental Cement Company, Hannibal, MO (United States); Constans, D.L. [Gossman Consulting, Inc., Peachtree City, GA (United States)

    1997-12-31

    The Continental Trial Burn strategy, presented at the 1995 BIF Conference, included the use of {open_quotes}data-in-lieu-of{close_quotes} from previous compliance testing conducted at the facility. Since the submission of the Trial Burn Plan and the 1995 presentation, Continental Cement has completed their two campaign trial burn. This paper will update the implementation of the Continental Trial Burn strategy. 1 fig., 1 tab.

  10. Challenges and lessons learned in conducting comparative-effectiveness trials.

    Science.gov (United States)

    Herrick, Linda M; Locke, G Richard; Zinsmeister, Alan R; Talley, Nicholas J

    2012-05-01

    The current health-care environment is demanding evidence-based medicine that relies on clinical trials as the basis for decisions. Clinician investigators are more often finding that they are personally responsible for coordinating large, multisite trials. We present strategies for successful implementation and management of multisite clinical trials and knowledge gained through an international, multisite randomized clinical trial. Topics include team composition, regulatory requirements, study organization and governance, communication strategies, recruitment and retention efforts, budget, technology transfer, and publication.

  11. What is the impact of ethics on clinical trials?

    Science.gov (United States)

    Spielman, Bethany

    2016-01-01

    Ethics has often been ignored or evaded in clinical trials, and the conditions under which global clinical trials are conducted make this problem likely to persist. Ethics can, however, have an impact at any of several stages of a trial when the individuals involved are committed. This editorial provides historical examples of ignoring, evading or, alternatively, using ethical help to improve clinical trials, and suggests that the actual role of ethics depends on the individuals involved.

  12. Research design considerations for chronic pain prevention clinical trials

    DEFF Research Database (Denmark)

    Gewandter, Jennifer S; Dworkin, Robert H; Turk, Dennis C;

    2015-01-01

    for clinical trials investigating the prevention of chronic pain. We present general design considerations for prevention trials in populations that are at relatively high risk for developing chronic pain. Specific design considerations included subject identification, timing and duration of treatment...... the potential to reduce the prevalence of chronic pain in the population. Additionally, standardization of outcomes in prevention clinical trials will facilitate meta-analyses and systematic reviews and improve detection of preventive strategies emerging from clinical trials....

  13. Differences Between Clinical Trials of Medical Devices and Drugs

    Institute of Scientific and Technical Information of China (English)

    ZHANG Zhi-jun; LIU Wei

    2014-01-01

    How to design clinical trials for medical devices is a problem plaguing the industry today. As there are many differences in clinical trials of medical devices and drugs. This paper describes the differences of the two points from the perspectivs of defi-nition of medical devices and drugs, scope, phasing, subjects and design of clinical trials in details, aiming to help the related personnel make scientific decisions while conduct-ing clinical trial design for medical devices.

  14. Randomization in substance abuse clinical trials

    Directory of Open Access Journals (Sweden)

    Woolson Robert F

    2006-02-01

    Full Text Available Abstract Background A well designed randomized clinical trial rates as the highest level of evidence for a particular intervention's efficacy. Randomization, a fundamental feature of clinical trials design, is a process invoking the use of probability to assign treatment interventions to patients. In general, randomization techniques pursue the goal of providing objectivity to the assignment of treatments, while at the same time balancing for treatment assignment totals and covariate distributions. Numerous randomization techniques, each with varying properties of randomness and balance, are suggested in the statistical literature. This paper reviews common randomization techniques often used in substance abuse research and an application from a National Institute on Drug Abuse (NIDA-funded clinical trial in substance abuse is used to illustrate several choices an investigator faces when designing a clinical trial. Results Comparisons and contrasts of randomization schemes are provided with respect to deterministic and balancing properties. Specifically, Monte Carlo simulation is used to explore the balancing nature of randomization techniques for moderately sized clinical trials. Results demonstrate large treatment imbalance for complete randomization with less imbalance for the urn or adaptive scheme. The urn and adaptive randomization methods display smaller treatment imbalance as demonstrated by the low variability of treatment allocation imbalance. For all randomization schemes, covariate imbalance between treatment arms was small with little variation between adaptive schemes, stratified schemes and unstratified schemes given that sample sizes were moderate to large. Conclusion We develop this paper with the goal of reminding substance abuse researchers of the broad array of randomization options available for clinical trial designs. There may be too quick a tendency for substance abuse researchers to implement the fashionable urn

  15. An interim analysis of recruitment to the COLOFOL trial

    DEFF Research Database (Denmark)

    Wille-Jørgensen, Peer; Laurberg, S.; Pahlman, L.;

    2009-01-01

    Objective To analyse the ongoing process of recruiting patients into a multicenter randomized trial on follow-up after curative surgery for colorectal cancer. The trial is registered in Clinical Trials Registration. Method Prospective registration of all operated patients as well as inclusions...

  16. Globally optimal trial design for local decision making.

    Science.gov (United States)

    Eckermann, Simon; Willan, Andrew R

    2009-02-01

    Value of information methods allows decision makers to identify efficient trial design following a principle of maximizing the expected value to decision makers of information from potential trial designs relative to their expected cost. However, in health technology assessment (HTA) the restrictive assumption has been made that, prospectively, there is only expected value of sample information from research commissioned within jurisdiction. This paper extends the framework for optimal trial design and decision making within jurisdiction to allow for optimal trial design across jurisdictions. This is illustrated in identifying an optimal trial design for decision making across the US, the UK and Australia for early versus late external cephalic version for pregnant women presenting in the breech position. The expected net gain from locally optimal trial designs of US$0.72M is shown to increase to US$1.14M with a globally optimal trial design. In general, the proposed method of globally optimal trial design improves on optimal trial design within jurisdictions by: (i) reflecting the global value of non-rival information; (ii) allowing optimal allocation of trial sample across jurisdictions; (iii) avoiding market failure associated with free-rider effects, sub-optimal spreading of fixed costs and heterogeneity of trial information with multiple trials. PMID:18435429

  17. The challenge of retaining customers acquired with free trials

    NARCIS (Netherlands)

    Datta, H.; Foubert, B.; van Heerde, H.J.

    2015-01-01

    Many service firms acquire customers by offering free-trial promotions. A crucial challenge is to retain customers acquired with these free trials. To address this challenge, firms need to understand how free-trial customers differ from regular customers in terms of their decision making to retain t

  18. Citation bias of hepato-biliary randomized clinical trials

    DEFF Research Database (Denmark)

    Kjaergard, Lise L; Gluud, Christian

    2002-01-01

    The objective of this study was to assess whether trials with a positive (i.e., statistically significant) outcome are cited more often than negative trials. We reviewed 530 randomized clinical trials on hepato-biliary diseases published in 11 English-language journals indexed in MEDLINE from 1985...

  19. To fail or not to fail : clinical trials in depression

    NARCIS (Netherlands)

    Santen, Gijs Willem Eduard

    2008-01-01

    To fail or not to fail – Clinical trials in depression investigates the causes of the high failure rate of clinical trials in depression research. Apart from the difficulties in the search for new antidepressants during drug discovery, faulty clinical trial designs hinder their evaluation during dru

  20. 21 CFR 886.1405 - Ophthalmic trial lens set.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic trial lens set. 886.1405 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1405 Ophthalmic trial lens set. (a) Identification. An ophthalmic trial lens set is a device that is a set of lenses of various dioptric...

  1. Interim analysis in long-term clinical trials

    NARCIS (Netherlands)

    G.A. van Es (Gerrit Anne)

    1990-01-01

    textabstractThe purpose of this dissertation is to evaluate the usefulness of both stopping rules and estimation methods in long-term clinical trials with interim analyses. The ASPECT trial, a long-term clinical trial to assess the effect of anticoagulant therapy on mortality in patients after myoca

  2. 21 CFR 886.1410 - Ophthalmic trial lens clip.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic trial lens clip. 886.1410 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1410 Ophthalmic trial lens clip. (a) Identification. An ophthalmic trial lens clip is a device intended to hold prisms, spheres, cylinders,...

  3. PREGNANCY WITH PLATELET FUNCTION DISORDER

    Directory of Open Access Journals (Sweden)

    Sheila K

    2014-01-01

    Full Text Available latelets play a vital role in haemostasis . Antenatal patients with platelet function disorders should be managed in tertiary care centres that are well equipped to tackle any obstetric haemorrhage that can ensue during labour and delivery . Primi gravida was admitted for safe confinement . She had been evaluated earlier for complaints of multiple episodes of mucosal bleeding . On evaluation she had nor mal platelet counts and coagulation factor assay was normal . Platelet aggregometry revealed mild disorder of platelet aggregation . She was planned for induction of labour after arranging enough blood and blood products . She got into active labour and was p ut on syntocinon augmentation . She had emergency Caesarean section for foetal distress . Oxytocics were given proactively . Intraoperatively platelet transfusions and tranexamic acid infusion were given . Complete haemostasis was achieved . She had an uneventf ul postoperative period . Patients with functional platelet disorders can be successfully managed with local application of antifibrinolytic agents like tranexamic acid , in case of minor bleeds . Platelet transfusions are very effective in tackling major ble eds , especially during surgeries and for obstetric indications . If a patient has the history of clinically significant bleeding suggestive of platelet dysfunction , appropriate platelet function tests should be obtained so that the risk of bleeding can be adequately assessed and therapy chosen more rationally . . In obstetric practice the response of such patients to platelet transfusions has been excellent

  4. [Clinical trials with advanced therapy medicinal products].

    Science.gov (United States)

    Schüssler-Lenz, M; Schneider, C K

    2010-01-01

    For advanced therapies, the same basic principles for assessment apply as for any other biotechnological medicinal product. Nevertheless, the extent of data for quality, safety, and efficacy can be highly specific. Until recently, advanced therapies were not uniformly regulated across Europe, e.g., tissue engineered products were regulated either as medicinal products or medical devices. Thus, for some products no data from clinical studies are available, e.g., for autologous chondrocyte products. The draft guideline on Good Clinical Practice for clinical trials with advanced therapies describes specific additional requirements, e.g., ensuring traceability. Most clinical studies with advanced therapies in Germany are still in early phase I or II trials with highly divergent types of products and clinical indications. The Committee for Advanced Therapies (CAT) at the European Medicines Agency (EMEA) has been established to meet the scientific and regulatory challenges with advanced therapies.

  5. Randomised controlled trials: important but overrated?

    LENUS (Irish Health Repository)

    Boylan, J F

    2012-02-01

    Practising physicians individualise treatments, hoping to achieve optimal outcomes by tackling relevant patient variables. The randomised controlled trial (RCT) is universally accepted as the best means of comparison. Yet doctors sometimes wonder if particular patients might benefit more from treatments that fared worse in the RCT comparisons. Such clinicians may even feel ostracised by their peers for stepping outside treatments based on RCTs and guidelines. Are RCTs the only acceptable evaluations of how patient care can be assessed and delivered? In this controversy we explore the interpretation of RCT data for practising clinicians facing individualised patient choices. First, critical care anaesthetists John Boylan and Brian Kavanagh emphasise the dangers of bias and show how Bayesian approaches utilise prior probabilities to improve posterior (combined) probability estimates. Secondly, Jane Armitage, of the Clinical Trial Service Unit in Oxford, argues why RCTs remain essential and explores how the quality of randomisation can be improved through systematic reviews and by avoiding selective reporting.

  6. How do researchers decide early clinical trials?

    Science.gov (United States)

    Grankvist, Hannah; Kimmelman, Jonathan

    2016-06-01

    Launch of clinical investigation represents a substantial escalation in commitment to a particular clinical translation trajectory; it also exposes human subjects to poorly understood interventions. Despite these high stakes, there is little to guide decision-makers on the scientific and ethical evaluation of early phase trials. In this article, we review policies and consensus statements on human protections, drug regulation, and research design surrounding trial launch, and conclude that decision-making is largely left to the discretion of research teams and sponsors. We then review what is currently understood about how research teams exercise this discretion, and close by laying out a research agenda for characterizing the way investigators, sponsors, and reviewers approach decision-making in early phase research.

  7. European Nicotinamide Diabetes Intervention Trial (ENDIT)

    DEFF Research Database (Denmark)

    Gale, E A M; Bingley, P J; Emmett, C L;

    2004-01-01

    BACKGROUND: Results of studies in animals and human beings suggest that type 1 diabetes is preventable. Nicotinamide prevents autoimmune diabetes in animal models, possibly through inhibition of the DNA repair enzyme poly-ADP-ribose polymerase and prevention of beta-cell NAD depletion. We aimed...... to assess whether high dose nicotinamide prevents or delays clinical onset of diabetes in people with a first-degree family history of type 1 diabetes. METHOD: We did a randomised double-blind placebo-controlled trial of nicotinamide in 552 relatives with confirmed islet cell antibody (ICA) levels of 20...... secretion. INTERPRETATION: Large-scale controlled trials of interventions designed to prevent the onset of type 1 diabetes are feasible, but nicotinamide was ineffective at the dose we used....

  8. THE RIGHT TO A FAIR TRIAL

    Directory of Open Access Journals (Sweden)

    FLORICA BRASOVEANU

    2012-05-01

    Full Text Available Among the general rights of the citizen on finds the free access to justice, the rights to defense and the right to legal security. The jurisprudence based on principles of law and on international treaties, caused the appearance, along the constitutional protection provided by default by a lawyer, of the need of fair and equitable procedures to ensure a balance in the rights of the parties. Today the right to a fair trial is a fundamental right most frequently invoked in front of Romanian courts, as in complaints to the European Court of Human Rights. This study is intended as a guide of the most important solutions that have been promoted to ensure the protection of the right to a fair trial with all the guarantees that are involved, starting with the right of access to justice and ending with the right to adversarial proceedings.

  9. On the Complexity of Trial and Error

    CERN Document Server

    Bei, Xiaohui; Zhang, Shengyu

    2012-01-01

    Motivated by certain applications from physics, biochemistry, economics, and computer science, in which the objects under investigation are not accessible because of various limitations, we propose a trial-and-error model to examine algorithmic issues in such situations. Given a search problem with a hidden input, we are asked to find a valid solution, to find which we can propose candidate solutions (trials), and use observed violations (errors), to prepare future proposals. In accordance with our motivating applications, we consider the fairly broad class of constraint satisfaction problems, and assume that errors are signaled by a verification oracle in the format of the index of a violated constraint (with the content of the constraint still hidden). Our discoveries are summarized as follows. On one hand, despite the seemingly very little information provided by the verification oracle, efficient algorithms do exist for a number of important problems. For the Nash, Core, Stable Matching, and SAT problems,...

  10. Malaria vaccines: lessons from field trials

    Directory of Open Access Journals (Sweden)

    Claudio J. Struchiner

    1994-07-01

    Full Text Available Malaria vaccine candidates have already been tested and new trials are being carried out. We present a brief description of specific issues of validity that are relevant when assessing vaccine efficacy in the field and illustrate how the application of these principles might improve our interpretation of the data being gathered in actual malaria vaccine field trials. Our discussion assumes that vaccine evaluation shares the same general principles of validity with epidemiologic causal inference, i.e., the process of drawing inferences from epidemiologic data aiming at the identification of causes of diseases. Judicious exercise of these principles indicates that, for meaningful interpretation, measures of vaccine efficacy require definitions based upon arguments conditional on the amount of exposure to infection, and specification of the initial and final states in which one believes the effect of interest takes place.

  11. Competing events and costs of clinical trials: Analysis of a randomized trial in prostate cancer

    International Nuclear Information System (INIS)

    Background: Clinical trial costs may be reduced by identifying enriched subpopulations of patients with favorable risk profiles for the events of interest. However, increased selectivity affects accrual rates, with uncertain impact on clinical trial cost. Methods: We conducted a secondary analysis of Southwest Oncology Group (SWOG) 8794 randomized trial of adjuvant radiotherapy for high-risk prostate cancer. The primary endpoint was metastasis-free survival (MFS), defined as time to metastasis or death from any cause (competing mortality). We used competing risks regression models to identify an enriched subgroup at high risk for metastasis and low risk for competing mortality. We applied a cost model to estimate the impact of enrichment on trial cost and duration. Results: The treatment effect on metastasis was similar in the enriched subgroup (HR, 0.42; 95% CI, 0.23–0.76) compared to the whole cohort (HR, 0.50; 95% CI, 0.30–0.81) while the effect on competing mortality was not significant in the subgroup or the whole cohort (HR 0.70; 95% CI 0.39–1.23, vs. HR 0.94; 95% CI, 0.68–1.31). Due to the higher incidence of metastasis relative to competing mortality in the enriched subgroup, the treatment effect on MFS was greater in the subgroup compared to the whole cohort (HR 0.55; 95% CI 0.36–0.82, vs. HR 0.77; 95% CI, 0.58–1.01). Trial cost was 75% less in the subgroup compared to the whole cohort ($1.7 million vs. $6.8 million), and the trial duration was 30% shorter (8.4 vs. 12.0 years). Conclusion: Competing event enrichment can reduce clinical trial cost and duration, without sacrificing generalizability

  12. Coping with Trial-to-Trial Variability of Event Related Signals: A Bayesian Inference Approach

    Science.gov (United States)

    Ding, Mingzhou; Chen, Youghong; Knuth, Kevin H.; Bressler, Steven L.; Schroeder, Charles E.

    2005-01-01

    In electro-neurophysiology, single-trial brain responses to a sensory stimulus or a motor act are commonly assumed to result from the linear superposition of a stereotypic event-related signal (e.g. the event-related potential or ERP) that is invariant across trials and some ongoing brain activity often referred to as noise. To extract the signal, one performs an ensemble average of the brain responses over many identical trials to attenuate the noise. To date, h s simple signal-plus-noise (SPN) model has been the dominant approach in cognitive neuroscience. Mounting empirical evidence has shown that the assumptions underlying this model may be overly simplistic. More realistic models have been proposed that account for the trial-to-trial variability of the event-related signal as well as the possibility of multiple differentially varying components within a given ERP waveform. The variable-signal-plus-noise (VSPN) model, which has been demonstrated to provide the foundation for separation and characterization of multiple differentially varying components, has the potential to provide a rich source of information for questions related to neural functions that complement the SPN model. Thus, being able to estimate the amplitude and latency of each ERP component on a trial-by-trial basis provides a critical link between the perceived benefits of the VSPN model and its many concrete applications. In this paper we describe a Bayesian approach to deal with this issue and the resulting strategy is referred to as the differentially Variable Component Analysis (dVCA). We compare the performance of dVCA on simulated data with Independent Component Analysis (ICA) and analyze neurobiological recordings from monkeys performing cognitive tasks.

  13. OpenTrials: towards a collaborative open database of all available information on all clinical trials.

    Science.gov (United States)

    Goldacre, Ben; Gray, Jonathan

    2016-01-01

    OpenTrials is a collaborative and open database for all available structured data and documents on all clinical trials, threaded together by individual trial. With a versatile and expandable data schema, it is initially designed to host and match the following documents and data for each trial: registry entries; links, abstracts, or texts of academic journal papers; portions of regulatory documents describing individual trials; structured data on methods and results extracted by systematic reviewers or other researchers; clinical study reports; and additional documents such as blank consent forms, blank case report forms, and protocols. The intention is to create an open, freely re-usable index of all such information and to increase discoverability, facilitate research, identify inconsistent data, enable audits on the availability and completeness of this information, support advocacy for better data and drive up standards around open data in evidence-based medicine. The project has phase I funding. This will allow us to create a practical data schema and populate the database initially through web-scraping, basic record linkage techniques, crowd-sourced curation around selected drug areas, and import of existing sources of structured and documents. It will also allow us to create user-friendly web interfaces onto the data and conduct user engagement workshops to optimise the database and interface designs. Where other projects have set out to manually and perfectly curate a narrow range of information on a smaller number of trials, we aim to use a broader range of techniques and attempt to match a very large quantity of information on all trials. We are currently seeking feedback and additional sources of structured data. PMID:27056367

  14. Shoulder Arthroplasty Trials Are Infrequently Registered: A Systematic Review of Trials

    Science.gov (United States)

    Sanchez, Zachary Carter; Herrington, James Murphy; Hensel, James Barrett; Henning, Nolan Michael; Scheckel, Caleb Josiah; Vassar, Matt

    2016-01-01

    Introduction With the intent of improving transparency in clinical research, the International Committee of Medical Journal Editors (ICMJE) established guidelines in 2005 regarding prospective clinical trial registration. This action worked to address bias related to selective outcome reporting in the medical literature. The objective of this study was to assess and characterize the quality of registration of clinical trials appearing in shoulder arthroplasty-related medical journals. Methods All randomized trials involving human subjects, pertaining to shoulder arthroplasty, published between July 1, 2005 and December 31, 2015, and indexed in either PubMed or SportDISCUS were analyzed. We assessed the prevalence of registration, the timing of registration relative to patient enrollment periods, and the variable rates of orthopedic journal compliance with ICMJE and Food and Drug Administration clinical registration standards for our study. Results Of the 382 articles identified, 345 (90.3%) were excluded due to failure to meet inclusion criteria. From the remaining 37, only 12 (32.4%) studies were found to be registered in a trial registry. Ten (10/12, 83.3%) of these provided their registration information within the body of the article. None of the included studies from ICMJE-recognized journals were registered. From 34 included studies from non-ICMJE recognized journals, 12 (35.3%) were registered. Conclusion The level of compliance with clinical trial registration guidelines in the decade since their release among shoulder arthroplasty trials in orthopedic journals is poor. Given the importance of the issue, the prevalence of the problem, and the fact that many other medical specialties have already made efforts to improve ICMJE compliance, further work on the part of orthopedic surgery journal authors and editors is needed to ensure the publication of unbiased results. Trial Registration UMIN000022487 PMID:27764210

  15. Prevention of abdominal wound infection (PROUD trial, DRKS00000390: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Heger Ulrike

    2011-11-01

    Full Text Available Abstract Background Wound infection affects a considerable portion of patients after abdominal operations, increasing health care costs and postoperative morbidity and affecting quality of life. Antibacterial coating has been suggested as an effective measure to decrease postoperative wound infections after laparotomies. The INLINE metaanalysis has recently shown the superiority of a slowly absorbable continuous suture for abdominal closure; with PDS plus® such a suture has now been made available with triclosan antibacterial coating. Methods/Design The PROUD trial is designed as a randomised, controlled, observer, surgeon and patient blinded multicenter superiority trial with two parallel groups and a primary endpoint of wound infection during 30 days after surgery. The intervention group will receive triclosan coated polydioxanone sutures, whereas the control group will receive the standard polydioxanone sutures; abdominal closure will otherwise be standardized in both groups. Statistical analysis is based on intention-to-treat population via binary logistic regression analysis, the total sample size of n = 750 is sufficient to ensure alpha = 5% and power = 80%, an interim analysis will be carried out after data of 375 patients are available. Discussion The PROUD trial will yield robust data to determine the effectiveness of antibacterial coating in one of the standard sutures for abdominal closure and potentially lead to amendment of current guidelines. The exploration of clinically objective parameters as well as quality of life holds immediate relevance for clinical management and the pragmatic trial design ensures high external validity. Trial Registration The trial protocol has been registered with the German Clinical Trials Register (DRKS00000390.

  16. Analysis of angiographic trial data in women.

    Science.gov (United States)

    Havel, R J

    1994-01-01

    There are few angiographic trials of cholesterol lowering in women. Two trials have included a sufficient number of women for meaningful assessment of lesion change, as determined by quantitative coronary angiography. In the University of California, San Francisco Specialized Center of Research in Arteriosclerosis (UCSF SCOR) trial, 72 patients (57% women) with familial hypercholesterolaemia (90% of whom had no overt coronary heart disease) were randomised to receive either diet and intensive drug therapy (combinations of colestipol, nicotinic acid and lovastatin) or diet and modest doses of colestipol, according to baseline low density lipoprotein cholesterol level. Coronary angiograms were obtained at 2-year intervals. Change in percentage area of stenosis (the primary end-point) in women receiving intensive drug treatment was -2.06% compared with +1.07% for the controls (p = 0.05). For the intensively treated men, corresponding values were -0.88% compared with +0.41% for the controls (difference not significant). In a recently completed trial in Canada, 269 men and 62 women with established coronary heart disease were randomised to receive either diet alone, or diet and lovastatin (up to 80 mg daily). In men, the increase in percentage diameter of stenosis was reduced by 43% (p = 0.05), and in women by 40% (not significant). By contrast, new lesions appeared in 4% of women assigned to intensive drug treatment, compared with 45% of those randomised to diet (p < 0.001). In men, new lesions appeared in 18% and 29% of patients, respectively (p = 0.047). These data suggest that coronary artery lesions in women respond at least as well as those in men to cholesterol lowering.

  17. The Postoperative Pain Assessment Skills Pilot Trial

    Directory of Open Access Journals (Sweden)

    Michael McGillion

    2011-01-01

    Full Text Available BACKGROUND/OBJECTIVES: Pain-related misbeliefs among health care professionals (HCPs are common and contribute to ineffective postoperative pain assessment. While standardized patients (SPs have been effectively used to improve HCPs’ assessment skills, not all centres have SP programs. The present equivalence randomized controlled pilot trial examined the efficacy of an alternative simulation method – deteriorating patient-based simulation (DPS – versus SPs for improving HCPs’ pain knowledge and assessment skills.

  18. Trial of Immune Globulin in Infant Botulism

    Directory of Open Access Journals (Sweden)

    J Gordon Millichap

    2006-02-01

    Full Text Available A 5-year, randomized, double-blind, placebo-controlled trial of the orphan drug Human Botulism Immune Globulin Intravenous (BIG-IV in 122 infants in California with confirmed infant botulism (75 caused by type A Clostridium botulinum toxin, and 47 by type B toxin was conducted at the California Department of Health Services, Richmond, CA; National Botulism Surveillance and Reference Laboratory, CDC and P, Atlanta; and Division of Biostatistics, University of California, Berkeley.

  19. Northwestern University trial emerging optical solutions

    CERN Multimedia

    2001-01-01

    Nortel Networks, SBC Ameritech and Northwestern University announced the creation of OMNInet (Optical Metro Network Initiative), a collaborative experimental network. The OMNInet technology trial, a four-site network located in Chicago, will provide a test bed for all-optical switching, advanced high-speed technology such as 10 gigabit Ethernet (10GE) and will test next-generation applications in healthcare, industrial design, finance and commerce.

  20. Characteristics of randomised trials on diseases in the digestive system registered in ClinicalTrials.gov: a retrospective analysis

    DEFF Research Database (Denmark)

    Wildt, Signe; Krag, Aleksander; Gluud, Liselotte

    2011-01-01

    Objectives To evaluate the adequacy of reporting of protocols for randomised trials on diseases of the digestive system registered in http://ClinicalTrials.gov and the consistency between primary outcomes, secondary outcomes and sample size specified in http://ClinicalTrials.gov and published...

  1. Privacy and confidentiality in pragmatic clinical trials.

    Science.gov (United States)

    McGraw, Deven; Greene, Sarah M; Miner, Caroline S; Staman, Karen L; Welch, Mary Jane; Rubel, Alan

    2015-10-01

    With pragmatic clinical trials, an opportunity exists to answer important questions about the relative risks, burdens, and benefits of therapeutic interventions. However, concerns about protecting the privacy of this information are significant and must be balanced with the imperative to learn from the data gathered in routine clinical practice. Traditional privacy protections for research uses of identifiable information rely disproportionately on informed consent or authorizations, based on a presumption that this is necessary to fulfill ethical principles of respect for persons. But frequently, the ideal of informed consent is not realized in its implementation. Moreover, the principle of respect for persons—which encompasses their interests in health information privacy—can be honored through other mechanisms. Data anonymization also plays a role in protecting privacy but is not suitable for all research, particularly pragmatic clinical trials. In this article, we explore both the ethical foundation and regulatory framework intended to protect privacy in pragmatic clinical trials. We then review examples of novel approaches to respecting persons in research that may have the added benefit of honoring patient privacy considerations. PMID:26374682

  2. Clinical Trials and Treatment of ATL

    Directory of Open Access Journals (Sweden)

    Kunihiro Tsukasaki

    2012-01-01

    Full Text Available ATL is a distinct peripheral T-lymphocytic malignancy associated with human T-cell lymphotropic virus type I (HTLV-1. The diversity in clinical features and prognosis of patients with this disease has led to its subtype-classification into four categories, acute, lymphoma, chronic, and smoldering types, defined by organ involvement, and LDH and calcium values. In case of acute, lymphoma, or unfavorable chronic subtypes (aggressive ATL, intensive chemotherapy like the LSG15 regimen (VCAP-AMP-VECP is usually recommended if outside of clinical trials, based on the results of a phase 3 trial. In case of favorable chronic or smoldering ATL (indolent ATL, watchful waiting until disease progression has been recommended, although the long-term prognosis was inferior to those of, for instance, chronic lymphoid leukemia. Retrospective analysis suggested that the combination of interferon alpha and zidovudine was apparently promising for the treatment of ATL, especially for types with leukemic manifestation. Allogeneic hematopoietic stem cell transplantation (allo-HSCT is also promising for the treatment of aggressive ATL possibly reflecting graft versus ATL effect. Several new agent trials for ATL are ongoing and in preparation, including a defucosylated humanized anti-CC chemokine receptor 4 monoclonal antibody, IL2-fused with diphtheria toxin, histone deacetylase inhibitors, a purine nucleoside phosphorylase inhibitor, a proteasome inhibitor, and lenalidomide.

  3. Privacy and confidentiality in pragmatic clinical trials.

    Science.gov (United States)

    McGraw, Deven; Greene, Sarah M; Miner, Caroline S; Staman, Karen L; Welch, Mary Jane; Rubel, Alan

    2015-10-01

    With pragmatic clinical trials, an opportunity exists to answer important questions about the relative risks, burdens, and benefits of therapeutic interventions. However, concerns about protecting the privacy of this information are significant and must be balanced with the imperative to learn from the data gathered in routine clinical practice. Traditional privacy protections for research uses of identifiable information rely disproportionately on informed consent or authorizations, based on a presumption that this is necessary to fulfill ethical principles of respect for persons. But frequently, the ideal of informed consent is not realized in its implementation. Moreover, the principle of respect for persons—which encompasses their interests in health information privacy—can be honored through other mechanisms. Data anonymization also plays a role in protecting privacy but is not suitable for all research, particularly pragmatic clinical trials. In this article, we explore both the ethical foundation and regulatory framework intended to protect privacy in pragmatic clinical trials. We then review examples of novel approaches to respecting persons in research that may have the added benefit of honoring patient privacy considerations.

  4. Clinical Trial Results Vary Widely, But Always Advance Research | NIH MedlinePlus the Magazine

    Science.gov (United States)

    ... of this page please turn Javascript on. Feature: Clinical Trials Clinical Trial Results Vary Widely, But Always Advance Research Past ... very emotional." Should You Be Interested in a Clinical Trial People volunteer to take part in clinical trials ...

  5. 76 FR 51375 - Dialogues in Diversifying Clinical Trials: Successful Strategies for Engaging Women and...

    Science.gov (United States)

    2011-08-18

    ... HUMAN SERVICES Food and Drug Administration Dialogues in Diversifying Clinical Trials: Successful Strategies for Engaging Women and Minorities in Clinical Trials AGENCY: Food and Drug Administration, HHS... Diversifying Clinical Trials: Successful Strategies for Engaging Women and Minorities in Clinical Trials....

  6. [PDCA Applied in Special Rectification of Medical Instrument Clinical Trial].

    Science.gov (United States)

    Wang, Lei; Qu, Xintao; Yu, Xiuchun

    2015-09-01

    PDCA cycle was applied in special rectification activities for medical instrument clinical trial, with quality criteria of implementation made. Completed medical instrument clinical trial from January 2011 to December 2012 was believed as control group, from January 2013 to December 2014 as PDCA group, the scores of clinical trial and the score rate of items were compared and analyzed. Results show quality scores of clinical trial in PDCA group are higher than that in control group (51 vs. 81, P rectification activities with PDCA applied in our department are feasible and effective. It significantly improves implement quality of medical instrument clinical trial.

  7. Globalization of clinical trials - where are we heading?

    Science.gov (United States)

    George, Melvin; Selvarajan, Sandhiya; S, Suresh-Kumar; Dkhar, Steven A; Chandrasekaran, Adithan

    2013-05-01

    The last decade has witnessed a greater transparency in clinical research with the advent of clinical trial registries. The aim of the study was to describe the trends in the globalization of clinical trials in the last five years. We performed an internet search using the WHO International clinical trials registry platform (WHO ICTRP) to identify the clinical trials conducted from January 2007 to December 31, 2011 among 25 countries. Among the 25 countries, the United States, Japan and Germany occupy the top positions in the total number of clinical trials conducted. Clinical trials in the US (36312) constituted 31.5% of the total number of trials performed during this period. However over a period of five years both US and Western Europe appear to show a decline, while the emerging countries show a rise in clinical trials registered. Among the emerging countries China, India and Republic of Korea are most active regions involved in clinical trials. Cancer, diabetes and respiratory diseases were most widely researched areas overall. Although the study confirms the transition in the clinical trials research towards emerging countries, the developed regions of the world still contribute to more than 70% of the trials registered worldwide.

  8. Improving the operational efficiency of Phase 2 and 3 trials.

    Science.gov (United States)

    Ganju, Jitendra

    2016-01-01

    The period toward the end of patients' participation in late stage blinded clinical trials is highly resource intensive for the sponsor. Consider first a Phase 3 trial. If the trial is a success, the sponsor has to implement the next steps, which might be filing for approval of the drug with the US Food and Drug Administration (FDA). To shorten the time interval between trial completion and submission of the package to the FDA, sponsors front-load as much work as is possible at risk. The approach is efficient if the trial succeeds but is inefficient if it fails. For a failed trial, the sponsor is unlikely to proceed with the plan that assumed success. Phase 2 trials are also at risk of being inefficient. Many activities, such as planning for drug interaction studies, thorough QT studies, or site selection for Phase 3 trials, are set in motion prior to completion of the Phase 2 trial. The work going on in parallel is wasted if the trial fails. The proposal to improve the efficiency is to let an independent entity provide the sponsor critical information at an earlier time necessary to reevaluate activities ongoing in parallel and external to the trial. PMID:27439520

  9. Electronic Cigarette Trial and Use among Young Adults: Reasons for Trial and Cessation of Vaping

    Directory of Open Access Journals (Sweden)

    Lois Biener

    2015-12-01

    Full Text Available This paper identifies predictors of trial and current use, and reasons for trying and ceasing use of electronic cigarettes (e-cigarettes among young adults, with particular attention to former and never smokers. Data are from a mail survey of a population-based sample of adults aged 18 to 35 (N = 4740 in three U.S. metropolitan areas. Survey items assessed trial and use of e-cigarettes, cigarette smoking status, and reasons for trial and for ceasing use of e-cigarettes. Almost 23% reported trial of e-cigarettes, and 8.4% reported using them in the past month. Current smokers were much more likely to have tried e-cigarettes (70.2% than both former (32.3% and never smokers (7.6%; p < 0.001 and to have used them in the past month (30.8%, 10.1%, 2.0% respectively; p < 0.001. Smoking status and scores on sensation seeking were significant independent predictors of both trial and current use of e-cigarettes. Never-smokers cite curiosity as the reason for trying e-cigarettes and also that their friends used them. The most frequent reason for ceasing use among never and former smokers was health concerns. For virtually none of them were e-cigarettes their first exposure to nicotine.

  10. Metacognition of Working Memory Performance: Trial-by-Trial Subjective Effects from a New Paradigm.

    Science.gov (United States)

    Garcia, Andrew C; Bhangal, Sabrina; Velasquez, Anthony G; Geisler, Mark W; Morsella, Ezequiel

    2016-01-01

    Investigators have begun to examine the fleeting urges and inclinations that subjects experience when performing tasks involving response interference and working memory. Building on this research, we developed a paradigm in which subjects, after learning to press certain buttons when presented with certain letters, are presented with two action-related letters (the memoranda) but must withhold responding (4 s) until cued to emit the response associated with only one of the two letters. In the Congruent condition, the action corresponds to the cue (e.g., memoranda = AB, cue = B, response = B); in the Incongruent condition, the action corresponds to the other item of the memoranda (e.g., memoranda = AB, cue = B, response = A). After each trial, subjects inputted a rating regarding their subjectively experienced "urge to err" on that trial. These introspection-based data revealed that, as found in previous research, urges to err were strongest for incongruent trials. Our findings reveal, first, that subjects can successfully perform this new task, even though it is more complex than that of previous studies, and second, that, in this new paradigm, reliable subjective, metacognitive data can be obtained on a trial-by-trial basis. We hope that our novel paradigm will serve as a foundation for future experimental projects on the relationship between working memory performance and consciousness-an under-explored nexus whose investigation is likely to reveal insights about working memory, cognitive control, and metacognition.

  11. Metacognition of Working Memory Performance: Trial-by-Trial Subjective Effects from a New Paradigm

    Science.gov (United States)

    Garcia, Andrew C.; Bhangal, Sabrina; Velasquez, Anthony G.; Geisler, Mark W.; Morsella, Ezequiel

    2016-01-01

    Investigators have begun to examine the fleeting urges and inclinations that subjects experience when performing tasks involving response interference and working memory. Building on this research, we developed a paradigm in which subjects, after learning to press certain buttons when presented with certain letters, are presented with two action-related letters (the memoranda) but must withhold responding (4 s) until cued to emit the response associated with only one of the two letters. In the Congruent condition, the action corresponds to the cue (e.g., memoranda = AB, cue = B, response = B); in the Incongruent condition, the action corresponds to the other item of the memoranda (e.g., memoranda = AB, cue = B, response = A). After each trial, subjects inputted a rating regarding their subjectively experienced “urge to err” on that trial. These introspection-based data revealed that, as found in previous research, urges to err were strongest for incongruent trials. Our findings reveal, first, that subjects can successfully perform this new task, even though it is more complex than that of previous studies, and second, that, in this new paradigm, reliable subjective, metacognitive data can be obtained on a trial-by-trial basis. We hope that our novel paradigm will serve as a foundation for future experimental projects on the relationship between working memory performance and consciousness—an under-explored nexus whose investigation is likely to reveal insights about working memory, cognitive control, and metacognition. PMID:27445897

  12. Using Big Data to Emulate a Target Trial When a Randomized Trial Is Not Available.

    Science.gov (United States)

    Hernán, Miguel A; Robins, James M

    2016-04-15

    Ideally, questions about comparative effectiveness or safety would be answered using an appropriately designed and conducted randomized experiment. When we cannot conduct a randomized experiment, we analyze observational data. Causal inference from large observational databases (big data) can be viewed as an attempt to emulate a randomized experiment-the target experiment or target trial-that would answer the question of interest. When the goal is to guide decisions among several strategies, causal analyses of observational data need to be evaluated with respect to how well they emulate a particular target trial. We outline a framework for comparative effectiveness research using big data that makes the target trial explicit. This framework channels counterfactual theory for comparing the effects of sustained treatment strategies, organizes analytic approaches, provides a structured process for the criticism of observational studies, and helps avoid common methodologic pitfalls. PMID:26994063

  13. Methods for therapeutic trials in COPD: lessons from the TORCH trial

    DEFF Research Database (Denmark)

    Keene, O N; Vestbo, J; Anderson, J A;

    2009-01-01

    The TORCH (Towards a Revolution in COPD Health) trial has highlighted some important issues in the design and analysis of long term trials in chronic obstructive pulmonary disease. These include collection of off-treatment exacerbation data, analysis of exacerbation rates and the effect of...... inclusion of patients receiving inhaled corticosteroids (ICS) prior to randomisation. When effective medications are available to patients who withdraw, inclusion of off-treatment data can mask important treatment effects on exacerbation rates. Analysis of on-treatment data avoids this bias but it needs to...... be combined with careful analysis of withdrawal patterns across treatments. The negative binomial model is currently the best approach to statistical analysis of exacerbation rates, while analysis of time to exacerbation can supplement this approach. In the TORCH trial, exacerbation rates were higher...

  14. Pre-trial evaluation of the potential for unblinding in drug trials: a prototype example.

    Science.gov (United States)

    Walter, S D; Awasthi, Shally; Jeyaseelan, L

    2005-08-01

    Blinding is an important design feature of randomised trials that may reduce bias in the results, compared to the situation where blinding is not possible or is not maintained. The literature provides some guidance for the evaluation of blinding in ongoing or completed studies, but the question of pre-trial assessment of the potential for unblinding has not been addressed. This paper describes the design and analysis of a prototype experiment for the pre-trial assessment of blinding in a drug trial. This work was motivated by a trial using antibiotic therapy, in which the investigators were concerned about the possibility of subjects being able to differentiate active medication from placebo, and thus become unblinded to their treatment assignment. A small experiment was mounted in which participants had to divide a random mixture of tablets into two groups. Statistical methods were developed to calculate the probability of a given number of similar tablets being classified into the same group by chance, with a modification to allow for some participants having constrained their responses to have equal numbers of tablets in each group. Differentiation of tablets by taste (the initial concern of the investigators) was not statistically different from chance. A smaller set of data on differentiation by appearance (a possibility not originally considered) had borderline statistical significance. After reviewing all these results, the investigators decided to proceed with the study without modifying the tablets, in part because subjects in the study would be unlikely to compare the two types of medication side-by-side. Our results suggest that blinding might sometimes be compromised in unexpected ways. Whenever possible, we suggest that similar and larger such experiments be carried out before the trial to assess whether blinding might be compromised. The methods proposed here could easily be adapted to evaluate the results of such experiments.

  15. Key concepts of clinical trials: a narrative review.

    Science.gov (United States)

    Umscheid, Craig A; Margolis, David J; Grossman, Craig E

    2011-09-01

    The recent focus of federal funding on comparative effectiveness research underscores the importance of clinical trials in the practice of evidence-based medicine and health care reform. The impact of clinical trials not only extends to the individual patient by establishing a broader selection of effective therapies, but also to society as a whole by enhancing the value of health care provided. However, clinical trials also have the potential to pose unknown risks to their participants, and biased knowledge extracted from flawed clinical trials may lead to the inadvertent harm of patients. Although conducting a well-designed clinical trial may appear straightforward, it is founded on rigorous methodology and oversight governed by key ethical principles. In this review, we provide an overview of the ethical foundations of trial design, trial oversight, and the process of obtaining approval of a therapeutic, from its pre-clinical phase to post-marketing surveillance. This narrative review is based on a course in clinical trials developed by one of the authors (DJM), and is supplemented by a PubMed search predating January 2011 using the keywords "randomized controlled trial," "patient/clinical research," "ethics," "phase IV," "data and safety monitoring board," and "surrogate endpoint." With an understanding of the key principles in designing and implementing clinical trials, health care providers can partner with the pharmaceutical industry and regulatory bodies to effectively compare medical therapies and thereby meet one of the essential goals of health care reform. PMID:21904102

  16. Eurados trial performance test for photon dosimetry

    DEFF Research Database (Denmark)

    Stadtmann, H.; Bordy, J.M.; Ambrosi, P.;

    2001-01-01

    Within the framework of the EURADOS Action entitled Harmonisation and Dosimetric Quality Assurance in Individual Monitoring for External Radiation, trial performance tests for whole-body and extremity personal dosemeters were carried out. Photon, beta and neutron dosemeters were considered. This...... paper summarises the results of the whole-body photon dosemeter test. Twenty-six dosimetry services from all EU Member States and Switzerland participated. Twelve different radiation fields were used to simulate various workplace irradiation fields. Dose values from 0.4 mSv to 80 mSv were chosen. From...

  17. THE PRE-TRIAL CHAMBER JUDGE

    Directory of Open Access Journals (Sweden)

    Edgar Laurentiu DUMBRAVA

    2014-12-01

    Full Text Available The importance of this work lies in important changes in the new Code of Criminal Procedure, amendments justified by the new realities of a democratic society in which criminal procedural rules must be adapted according to the daily realities in the achievement of justice. The purpose of the paper is given by the need of approaching at a theoretically level the institution of The Pre-Trial Chamber Judge, given that so far there have not been developed any works on the subject. This paper addresses both practitioners and litigants.

  18. THE PRE-TRIAL CHAMBER JUDGE

    Directory of Open Access Journals (Sweden)

    Edgar Laurenţiu DUMBRAVĂ

    2014-05-01

    Full Text Available The importance of this work lies in important changes in the new Code of Criminal Procedure, amendments justified by the new realities of a democratic society in which criminal procedural rules must be adapted according to the daily realities in the achievement of justice. The purpose of the paper is given by the need of approaching at a theoretically level the institution of The Pre-Trial Chamber Judge, given that so far there have not been developed any works on the subject. This paper addresses both practitioners and litigants.

  19. The Electronic Evidence in Trial Proceedings

    Directory of Open Access Journals (Sweden)

    Monica Pocora

    2015-05-01

    Full Text Available This paper will consider theoretical and practical issues which arise in trial proceedings, throughout the virtual presence of persons involved. The EU Convention of 2000 provide the legal base for the use of video conference. In most jurisdictions, all forms of evidence is admissible, subject to rules relating to the exclusion of evidence because of improper actions or because the inclusion of the evidence would be unfair to the defendant. There is a difference between the admissibility of the evidence and laying the correct foundations before the evidence can be admitted.

  20. Statistical properties of randomization in clinical trials.

    Science.gov (United States)

    Lachin, J M

    1988-12-01

    This is the first of five articles on the properties of different randomization procedures used in clinical trials. This paper presents definitions and discussions of the statistical properties of randomization procedures as they relate to both the design of a clinical trial and the statistical analysis of trial results. The subsequent papers consider, respectively, the properties of simple (complete), permuted-block (i.e., blocked), and urn (adaptive biased-coin) randomization. The properties described herein are the probabilities of treatment imbalances and the potential effects on the power of statistical tests; the permutational basis for statistical tests; and the potential for experimental biases in the assessment of treatment effects due either to the predictability of the random allocations (selection bias) or the susceptibility of the randomization procedure to covariate imbalances (accidental bias). For most randomization procedures, the probabilities of overall treatment imbalances are readily computed, even when a stratified randomization is used. This is important because treatment imbalance may affect statistical power. It is shown, however, that treatment imbalance must be substantial before power is more than trivially affected. The differences between a population versus a permutation model as a basis for a statistical test are reviewed. It is argued that a population model can only be invoked in clinical trials as an untestable assumption, rather than being formally based on sampling at random from a population. On the other hand, a permutational analysis based on the randomization actually employed requires no assumptions regarding the origin of the samples of patients studied. The large sample permutational distribution of the family of linear rank tests is described as a basis for easily conducting a variety of permutation tests. Subgroup (stratified) analyses, analyses when some data are missing, and regression model analyses are also

  1. Randomised Controlled Trials in Education Research: A Case Study of an Individually Randomised Pragmatic Trial

    Science.gov (United States)

    Torgerson, Carole J.

    2009-01-01

    The randomised controlled trial (RCT) is an evaluative method used by social scientists in order to establish whether or not an intervention is effective. This contribution discusses the fundamental aspects of good RCT design. These are illustrated through the use of a recently completed RCT which evaluated an information and communication…

  2. Acupuncture for Posttraumatic Stress Disorder: A Systematic Review of Randomized Controlled Trials and Prospective Clinical Trials

    Directory of Open Access Journals (Sweden)

    Young-Dae Kim

    2013-01-01

    Full Text Available To evaluate the current evidence for effectiveness of acupuncture for posttraumatic stress disorder (PTSD in the form of a systematic review, a systematic literature search was conducted in 23 electronic databases. Grey literature was also searched. The key search terms were “acupuncture” and “PTSD.” No language restrictions were imposed. We included all randomized or prospective clinical trials that evaluated acupuncture and its variants against a waitlist, sham acupuncture, conventional therapy control for PTSD, or without control. Four randomized controlled trials (RCTs and 2 uncontrolled clinical trials (UCTs out of 136 articles in total were systematically reviewed. One high-quality RCT reported that acupuncture was superior to waitlist control and therapeutic effects of acupuncture and cognitive-behavioral therapy (CBT were similar based on the effect sizes. One RCT showed no statistical difference between acupuncture and selective serotonin reuptake inhibitors (SSRIs. One RCT reported a favorable effect of acupoint stimulation plus CBT against CBT alone. A meta-analysis of acupuncture plus moxibustion versus SSRI favored acupuncture plus moxibustion in three outcomes. This systematic review and meta-analysis suggest that the evidence of effectiveness of acupuncture for PTSD is encouraging but not cogent. Further qualified trials are needed to confirm whether acupuncture is effective for PTSD.

  3. Design of clinical trials in acute kidney injury: report from an NIDDK workshop on trial methodology.

    Science.gov (United States)

    Palevsky, Paul M; Molitoris, Bruce A; Okusa, Mark D; Levin, Adeera; Waikar, Sushrut S; Wald, Ron; Chertow, Glenn M; Murray, Patrick T; Parikh, Chirag R; Shaw, Andrew D; Go, Alan S; Faubel, Sarah G; Kellum, John A; Chinchilli, Vernon M; Liu, Kathleen D; Cheung, Alfred K; Weisbord, Steven D; Chawla, Lakhmir S; Kaufman, James S; Devarajan, Prasad; Toto, Robert M; Hsu, Chi-yuan; Greene, Tom; Mehta, Ravindra L; Stokes, John B; Thompson, Aliza M; Thompson, B Taylor; Westenfelder, Christof S; Tumlin, James A; Warnock, David G; Shah, Sudhir V; Xie, Yining; Duggan, Emily G; Kimmel, Paul L; Star, Robert A

    2012-05-01

    Acute kidney injury (AKI) remains a complex clinical problem associated with significant short-term morbidity and mortality and lacking effective pharmacologic interventions. Patients with AKI experience longer-term risks for progressive chronic ESRD, which diminish patients' health-related quality of life and create a larger burden on the healthcare system. Although experimental models have yielded numerous promising agents, translation into clinical practice has been unsuccessful, possibly because of issues in clinical trial design, such as delayed drug administration, masking of therapeutic benefit by adverse events, and inadequate sample size. To address issues of clinical trial design, the National Institute of Diabetes and Digestive and Kidney Diseases sponsored a workshop titled "Clinical Trials in Acute Kidney Injury: Current Opportunities and Barriers" in December 2010. Workshop participants included representatives from academia, industry, and government agencies whose areas of expertise spanned basic science, clinical nephrology, critical care medicine, biostatistics, pharmacology, and drug development. This document summarizes the discussions of collaborative workgroups that addressed issues related to patient selection, study endpoints, the role of novel biomarkers, sample size and power calculations, and adverse events and pilot/feasibility studies in prevention and treatment of AKI. Companion articles outline the discussions of workgroups for model trials related to prevention or treatment of established AKI in different clinical settings, such as in patients with sepsis.

  4. The Paracetamol (Acetaminophen) In Stroke (PAIS) trial : a multicentre, randomised, placebo-controlled, phase III trial

    NARCIS (Netherlands)

    den Hertog, Heleen M.; van der Worp, H. Bart; van Gemert, H. Maarten A.; Algra, Ate; Kappelle, L. Jaap; Van Gijn, Jan; Koudstaal, Peter J.; Dippel, Diederik W. J.

    2009-01-01

    Background High body temperature in the first 12-24 h after stroke onset is associated with poor functional outcome. The Paracetamol (Acetaminophen) In Stroke (PAIS) trial aimed to assess whether early treatment with paracetamol improves functional outcome in patients with acute stroke by reducing b

  5. Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials Published in the Journal of Consulting and Clinical Psychology.

    Directory of Open Access Journals (Sweden)

    Marleine Azar

    Full Text Available Confidence that randomized controlled trial (RCT results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP is the primary trials journal amongst American Psychological Association (APA journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1 adequacy of primary outcome analysis definitions; (2 registration status; and, (3 among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals.Eligible RCTs were published in JCCP in 2013-2014. For each RCT, two investigators independently extracted data on (1 adequacy of outcome analysis definitions in the published report, (2 whether the RCT was registered prior to enrolling patients, and (3 adequacy of outcome registration.Of 70 RCTs reviewed, 12 (17.1% adequately defined primary or secondary outcome analyses, whereas 58 (82.3% had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7% registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029. The proportion of registered trials in JCCP (55.7% was comparable to behavioral medicine journals (52.6%; p = 0.709.The quality of published outcome analysis definitions and trial registrations in JCCP is

  6. Financial managers' costing expertise is needed in clinical trials.

    Science.gov (United States)

    West, D A; Balas, E A; West, T D

    2000-01-01

    In addition to providing comparable and verifiable evidence regarding outcomes, clinical trials could also serve as sources of accurate and replicable financial information. Trial reports that identify expenses associated with effective diagnostic and therapeutic interventions enable cost controls. Standardized cost calculations could help clinicians and administrators identify more efficient health care technologies. Unfortunately, relatively few published trials include economic analyses and when they do, data are incomplete. Based on analyses of 97 clinical trial reports, this article proposes a standard costing format. Health care financial managers have the costing expertise necessary to implement and interpret standardized cost calculations for clinical trials. With the active involvement of financial managers, a standard costing format for clinical trials can be achieved. PMID:10961828

  7. Statistical challenges for central monitoring in clinical trials: a review.

    Science.gov (United States)

    Oba, Koji

    2016-02-01

    Recently, the complexity and costs of clinical trials have increased dramatically, especially in the area of new drug development. Risk-based monitoring (RBM) has been attracting attention as an efficient and effective trial monitoring approach, which can be applied irrespectively of the trial sponsor, i.e., academic institution or pharmaceutical company. In the RBM paradigm, it is expected that a statistical approach to central monitoring can help improve the effectiveness of on-site monitoring by prioritizing and guiding site visits according to central statistical data checks, as evidenced by examples of actual trial datasets. In this review, several statistical methods for central monitoring are presented. It is important to share knowledge about the role and performance capabilities of statistical methodology among clinical trial team members (i.e., sponsors, investigators, data managers, monitors, and biostatisticians) in order to adopt central statistical monitoring for assessing data quality in the actual clinical trial. PMID:26499195

  8. Observer bias in randomized clinical trials with measurement scale outcomes

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida;

    2013-01-01

    BACKGROUND: Clinical trials are commonly done without blinded outcome assessors despite the risk of bias. We wanted to evaluate the effect of nonblinded outcome assessment on estimated effects in randomized clinical trials with outcomes that involved subjective measurement scales. METHODS: We...... conducted a systematic review of randomized clinical trials with both blinded and nonblinded assessment of the same measurement scale outcome. We searched PubMed, EMBASE, PsycINFO, CINAHL, Cochrane Central Register of Controlled Trials, HighWire Press and Google Scholar for relevant studies. Two...... investigators agreed on the inclusion of trials and the outcome scale. For each trial, we calculated the difference in effect size (i.e., standardized mean difference between nonblinded and blinded assessments). A difference in effect size of less than 0 suggested that nonblinded assessors generated more...

  9. Practical considerations for adaptive trial design and implementation

    CERN Document Server

    Pinheiro, José; Kuznetsova, Olga

    2014-01-01

    This edited volume is a definitive text on adaptive clinical trial designs from creation and customization to utilization. As this book covers the full spectrum of topics involved in the adaptive designs arena, it will serve as a valuable reference for researchers working in industry, government and academia. The target audience is anyone involved in the planning and execution of clinical trials, in particular, statisticians, clinicians, pharmacometricians, clinical operation specialists, drug supply managers, and infrastructure providers.  In spite of the increased efficiency of adaptive trials in saving costs and time, ultimately getting drugs to patients sooner, their adoption in clinical development is still relatively low.  One of the chief reasons is the higher complexity of adaptive design trials as compared to traditional trials. Barriers to the use of clinical trials with adaptive features include the concerns about the integrity of study design and conduct, the risk of regulatory non-acceptance, t...

  10. Observer bias in randomized clinical trials with measurement scale outcomes

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida;

    2013-01-01

    BACKGROUND: Clinical trials are commonly done without blinded outcome assessors despite the risk of bias. We wanted to evaluate the effect of nonblinded outcome assessment on estimated effects in randomized clinical trials with outcomes that involved subjective measurement scales. METHODS: We...... conducted a systematic review of randomized clinical trials with both blinded and nonblinded assessment of the same measurement scale outcome. We searched PubMed, EMBASE, PsycINFO, CINAHL, Cochrane Central Register of Controlled Trials, HighWire Press and Google Scholar for relevant studies. Two......%). Heterogeneity was moderate (I(2) = 46%, p = 0.02) and unexplained by metaregression. INTERPRETATION: We provide empirical evidence for observer bias in randomized clinical trials with subjective measurement scale outcomes. A failure to blind assessors of outcomes in such trials results in a high risk...

  11. The Cessation in Pregnancy Incentives Trial (CPIT: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Tappin David M

    2012-07-01

    Full Text Available Abstract Background Seventy percent of women in Scotland have at least one baby, making pregnancy an opportunity to help most young women quit smoking before their own health is irreparably compromised. By quitting during pregnancy their infants will be protected from miscarriage and still birth as well as low birth weight, asthma, attention deficit disorder and adult cardiovascular disease. In the UK, the NICE guidelines: ‘How to stop smoking in pregnancy and following childbirth’ (June 2010 highlighted that little evidence exists in the literature to confirm the efficacy of financial incentives to help pregnant smokers to quit. Its first research recommendation was to determine: Within a UK context, are incentives an acceptable, effective and cost-effective way to help pregnant women who smoke to quit? Design and methods This study is a phase II exploratory individually randomized controlled trial comparing standard care for pregnant smokers with standard care plus the additional offer of financial voucher incentives to engage with specialist cessation services and/or to quit smoking during pregnancy. Participants (n = 600 will be pregnant smokers identified at maternity booking who, when contacted by specialist cessation services, agree to having their details passed to the NHS Smokefree Pregnancy Study Helpline to discuss the trial. The NHS Smokefree Pregnancy Study Helpline will be responsible for telephone consent and follow-up in late pregnancy. The primary outcome will be self reported smoking in late pregnancy verified by cotinine measurement. An economic evaluation will refine cost data collection and assess potential cost-effectiveness while qualitative research interviews with clients and health professionals will assess the level of acceptance of this form of incentive payment. The research questions are: What is the likely therapeutic efficacy? Are incentives potentially cost-effective? Is individual randomization an

  12. Diagnostic randomized controlled trials: the final frontier.

    Science.gov (United States)

    Rodger, Marc; Ramsay, Tim; Fergusson, Dean

    2012-08-16

    Clinicians, patients, governments, third-party payers, and the public take for granted that diagnostic tests are accurate, safe and effective. However, we may be seriously misled if we are relying on robust study design to ensure accurate, safe, and effective diagnostic tests. Properly conducted, randomized controlled trials are the gold standard for assessing the effectiveness and safety of interventions, yet are rarely conducted in the assessment of diagnostic tests. Instead, diagnostic cohort studies are commonly performed to assess the characteristics of a diagnostic test including sensitivity and specificity. While diagnostic cohort studies can inform us about the relative accuracy of an experimental diagnostic intervention compared to a reference standard, they do not inform us about whether the differences in accuracy are clinically important, or the degree of clinical importance (in other words, the impact on patient outcomes). In this commentary we provide the advantages of the diagnostic randomized controlled trial and suggest a greater awareness and uptake in their conduct. Doing so will better ensure that patients are offered diagnostic procedures that will make a clinical difference.

  13. Clinical trials in branch retinal vein occlusion

    Directory of Open Access Journals (Sweden)

    Tandava Krishnan Panakanti

    2016-01-01

    Full Text Available Branch retinal vein occlusion (BRVO is the second most common retinal vascular disorder. The management of macular edema has changed considerably over time. The laser is considered the gold standard treatment for over two decades. However, visual recovery with laser is usually slow and incomplete. The advent of intravitreal agents, specifically anti-vascular endothelial growth factors (VEGF have heralded a new era which promises rapid recovery of vision and quality of vision. Randomized clinical trials have reported optimal results with anti-VEGF agents (ranibizumab, bevacizumab, and aflibercept compared to laser therapy or steroids. However, nearly 50% of the patients require repeat intravitreal anti-VEGF therapy up to 4 years after initiating therapy to sustain the visual gains. The adverse events (systemic and ocular of these agents are minimal. Monotherapy with anti-VEGF agents have been found to provide better results than any combination with laser. This review article summarizes evidence from randomized controlled trials evaluating treatment options for the treatment of macular edema secondary to BRVO with a special focus on anti-VEGF therapy.

  14. Ethical pitfalls in neonatal comparative effectiveness trials.

    Science.gov (United States)

    Modi, Neena

    2014-01-01

    oxygen that are too low or too high. Investigators in the UK, Australia, New Zealand and the USA designed randomized controlled trials to provide more precise guidance, by determining whether targeting the lower end of the accepted range (85-89%) resulted in reduced retinopathy of prematurity when compared with the upper end of the accepted range (91-95%). Between 2004 and 2009, the US SUPPORT trial (Surfactant, Positive Pressure and Oxygenation Randomized Trial) recruited approximately 1,300 infants and showed that babies at the higher end of the recommended oxygen saturation range had a greater incidence of retinopathy of prematurity, but that, unexpectedly, babies at the lower end had a higher risk of death [1]. The data monitoring committees of the BOOST II (Oxygen Saturation and Outcomes in Preterm Infants) trials in the UK, Australia and New Zealand reviewed their interim data, confirmed the higher risk of death in babies randomized to the lower saturation range, and halted further recruitment [2]. Without the trials, the lower saturation target would have continued to be applied to many babies, and many would have died as a result. Though many uncertainties remain, the trials facilitated advances in care. However, in March 2013, the lead investigators for the SUPPORT trial were informed by the US 'Office for Human Research Protections' that they were 'in violation of the regulatory requirements for informed consent, stemming from the failure to describe the reasonably foreseeable risks of blindness, neurological damage and death' [3]. This extraordinary conclusion indicates that the US regulators considered the researchers to be at fault for failing to foresee an unexpected trial result, and for randomizing babies to receive oxygen within the accepted standard-of-care limits. The ruling further implies that the regulators consider that clinicians are acting ethically when they deliver an accepted but non-evidence-based treatment based upon their personal bias, but

  15. Citation Sentiment Analysis in Clinical Trial Papers.

    Science.gov (United States)

    Xu, Jun; Zhang, Yaoyun; Wu, Yonghui; Wang, Jingqi; Dong, Xiao; Xu, Hua

    2015-01-01

    In scientific writing, positive credits and negative criticisms can often be seen in the text mentioning the cited papers, providing useful information about whether a study can be reproduced or not. In this study, we focus on citation sentiment analysis, which aims to determine the sentiment polarity that the citation context carries towards the cited paper. A citation sentiment corpus was annotated first on clinical trial papers. The effectiveness of n-gram and sentiment lexicon features, and problem-specified structure features for citation sentiment analysis were then examined using the annotated corpus. The combined features from the word n-grams, the sentiment lexicons and the structure information achieved the highest Micro F-score of 0.860 and Macro-F score of 0.719, indicating that it is feasible to use machine learning methods for citation sentiment analysis in biomedical publications. A comprehensive comparison between citation sentiment analysis of clinical trial papers and other general domains were conducted, which additionally highlights the unique challenges within this domain.

  16. The Home-Based Older People's Exercise (HOPE trial: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Forster Anne

    2011-06-01

    Full Text Available Abstract Background Frailty is common in older age, and is associated with important adverse health outcomes including increased risk of disability and admission to hospital or long-term care. Exercise interventions for frail older people have the potential to reduce the risk of these adverse outcomes by increasing muscle strength and improving mobility. Methods/Design The Home-Based Older People's Exercise (HOPE trial is a two arm, assessor blind pilot randomised controlled trial (RCT to assess the effectiveness of a 12 week exercise intervention (the HOPE programme designed to improve the mobility and functional abilities of frail older people living at home, compared with usual care. The primary outcome is the timed-up-and-go test (TUGT, measured at baseline and 14 weeks post-randomisation. Secondary outcomes include the Barthel Index of activities of daily living (ADL, EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D quality of life measure and the geriatric depression scale (GDS, measured at baseline and 14 weeks post-randomisation. We will record baseline frailty using the Edmonton Frail Scale (EFS, record falls and document muscle/joint pain. We will test the feasibility of collection of data to identify therapy resources required for delivery of the intervention. Discussion The HOPE trial will explore and evaluate a home-based exercise intervention for frail older people. Although previous RCTs have used operationalised, non-validated methods of measuring frailty, the HOPE trial is, to our knowledge, the first RCT of an exercise intervention for frail older people that includes a validated method of frailty assessment at baseline. Trial registration ISRCTN: ISRCTN57066881

  17. Challenges of randomized controlled trial design in plastic surgery.

    Science.gov (United States)

    Hassanein, Aladdin H; Herrera, Fernando A; Hassanein, Omar

    2011-01-01

    Randomized controlled trials are the gold standard of evidence-based medicine. In the field of plastic surgery, designing these studies is much more challenging than in pharmaceutical medicine. Randomized trials in plastic surgery encompass several road blocks including problems shared with other surgical trials: equipoise, high cost, placebo issues and learning curves following the establishment of a novel approach. In addition, plastic surgery has more subjective outcomes, thus making study design even more difficult in assessing the end result.

  18. Two-stage adaptive designs in early phase clinical trials

    OpenAIRE

    Xu, Jiajing; 徐佳静

    2013-01-01

    The primary goal of clinical trials is to collect enough scientific evidence for a new intervention. Despite the widespread use of equal randomization in clinical trials, response-adaptive randomization has attracted considerable interest in terms of ethical concerns. In this thesis, delayed response problems and innovative designs for cytostatic agents in oncology clinical trials are studied. There is typically a prerun of equal randomization before the implementation of response-adaptiv...

  19. Trial Outcome and Associative Learning Signals in the Monkey Hippocampus

    OpenAIRE

    Wirth, Sylvia; Avsar, Emin; Chiu, Cindy C.; Sharma, Varun; Smith, Anne C.; Emery N Brown; Suzuki, Wendy A.

    2009-01-01

    In tasks of associative learning, animals establish new links between unrelated items by using information about trial outcome to strengthen correct/rewarded associations and modify incorrect/unrewarded ones. To study how hippocampal neurons convey information about reward and trial outcome during new associative learning, we recorded hippocampal neurons as monkeys learned novel object-place associations. A large population of hippocampal neurons (50%) signaled trial outcome by differentiatin...

  20. Poor Reporting of Scientific Leadership Information in Clinical Trial Registers

    OpenAIRE

    Melanie Sekeres; Gold, Jennifer L.; An-Wen Chan; Joel Lexchin; David Moher; Van Laethem, Marleen L. P.; James Maskalyk; Lorraine Ferris; Nathan Taback; Rochon, Paula A

    2008-01-01

    BACKGROUND: In September 2004, the International Committee of Medical Journal Editors (ICMJE) issued a Statement requiring that all clinical trials be registered at inception in a public register in order to be considered for publication. The World Health Organization (WHO) and ICMJE have identified 20 items that should be provided before a trial is considered registered, including contact information. Identifying those scientifically responsible for trial conduct increases accountability. Th...