Study Of Tranexamic Acid For The Reduction Of Blood Loss In Patients Undergoing Surgery For Long Bone Fracture
2011年6月6日 更新者：Pfizer
Prospective Randomized Phase IV Open Label Comparative Study Of Tranexamic Acid Plus Standard Of Care Versus Standard Of Care For The Reduction Of Blood Loss In Patients Undergoing Surgery For Long Bone Fracture
Tranexamic acid has been shown to reduce postoperative blood losses and transfusion requirements in a number of types of surgery.
Most trials in orthopedic surgery have been conducted in arthroplasty, hip fracture and spine surgeries.
This study would aim to see the effect of tranexamic acid in reduction of blood loss and transfusions for long bone fracture surgery, primarily fracture shaft of femur.
研究概览
研究类型
介入性
注册 (实际的)
82
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Tamil Nadu
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Coimbatore、Tamil Nadu、印度、641009
- Pfizer Investigational Site
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 50年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patient undergoing surgery for fracture shaft of femur
Exclusion Criteria:
- Patients with a platelet count less than 100, 000/mm3 or history of thrombocytopenia
- Patients with known coagulopathy
- Patients with anemia (hemoglobin levels less than 8 mg/dl or hematocrit <24%)
- Patients with documented DVT or PE at screening or in past three months
- Patients having known hypersensitivity to tranexamic acid or any other constituent of the product
- Patients with any associated major illness (e.g., severe cardiac or respiratory disease)
- Anticoagulants (other than LMWH or heparin in prophylactic doses to prevent deep vein thrombosis), direct thrombin inhibitors or thrombolytic therapy administered or completed within last week
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：A
Tranexamic Acid plus standard of care
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Tranexamic acid given slowly intravenously (15 mg/kg body weight) 15 minutes before surgery followed by a second dose at three hour interval from first dose and third dose at three hour interval from the second + Standard of care (Standard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss)
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其他：B
Standard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss.
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Standard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Total Blood Loss
大体时间：Baseline through Day 7 post-surgery
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Total blood loss was defined as the sum of intra-operative and post-operative blood loss.
It was measured by weighing the drapes/ dressings or swabs prior to soaking to measure difference in weight and checking drain collectors until drains were removed.
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Baseline through Day 7 post-surgery
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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术中失血
大体时间：第 1 天（手术结束）
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通过在浸泡之前称重手术单/敷料或拭子以测量重量差异并检查引流收集器直到引流被移除来测量术中失血。
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第 1 天（手术结束）
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Post-operative Blood Loss
大体时间：1, 4, 8 and 24 hours post-surgery
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Post-operative blood loss was defined as the sum of the drainage volumes measured over post-operative days 1, 2, and at drain removal.
It was measured by weighing the drapes/ dressings or swabs prior to soaking to measure difference in weight and checking drain collectors until drains were removed.
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1, 4, 8 and 24 hours post-surgery
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Total Blood Loss Assessed by Gross' Formula
大体时间：Day 7 post-surgery
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Gross's formula for estimating total blood loss: Estimated blood volume*[(Hematocrit initial - Hematocrit final)/ Hematocrit average]; where estimated blood volume equals body weight in kilograms (kg) *70 mL/kg.
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Day 7 post-surgery
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Number of Participants Receiving Transfusions
大体时间：Up to day 7 post-surgery
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A uniform transfusion protocol was maintained for all participants in the study.
Transfusion to be triggered at 8.0 milligram/deciliter (mg/dl) hemoglobin or haematocrit value of 24 percent.
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Up to day 7 post-surgery
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Change From Baseline in Hemoglobin Levels at End of Surgery, 1 hr Post-surgery, and Mornings of Day 1, Day 2, Day 4, Day 7 or Early Termination (ET) Post-surgery
大体时间：Baseline through end of surgery, 1 hr post-surgery, and mornings of Day 1, Day 2, Day 4, Day 7 or ET post-surgery
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Baseline through end of surgery, 1 hr post-surgery, and mornings of Day 1, Day 2, Day 4, Day 7 or ET post-surgery
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Number of Participants With Deep Vein Thrombosis (DVT) Post Surgery
大体时间：Day 5 post-surgery
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DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel.
Symptoms of DVT included pain in the lower limb, localized tenderness, swelling and warmth.
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Day 5 post-surgery
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2009年4月1日
初级完成 (实际的)
2010年6月1日
研究完成 (实际的)
2010年6月1日
研究注册日期
首次提交
2009年1月14日
首先提交符合 QC 标准的
2009年1月14日
首次发布 (估计)
2009年1月16日
研究记录更新
最后更新发布 (估计)
2011年6月28日
上次提交的符合 QC 标准的更新
2011年6月6日
最后验证
2011年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.