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临床试验/NCT02684851
NCT02684851已完成3 期

The Use of Tranexamic Acid to Reduce Blood Loss in Acetabular Surgery

Wake Forest University Health Sciences2 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2012年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
87
试验地点
2
主要终点
Units of Packed Red Blood Cells Transfused

研究概览

简要总结

The purpose of this study is to determine if patients undergoing acetabular ORIF (open reduction with internal fixation) who receive tranexamic acid have a reduced risk of allogenic blood transfusion, perioperative blood loss, wound complication and higher risk for thromboembolic events compared to patients who receive placebo. Investigators want to determine the cost-effectiveness related to allogenic blood transfusion as a blood loss management strategy in acetabular open reduction internal fixation (ORIF). Orthopaedic surgery carries with it a significant risk for blood loss. Current management of perioperative blood loss is the use of allogenic blood transfusion. Allogenic blood transfusion carries with it a risk for HIV and Hepatitis C as well as multiple adverse reactions. There have been significant efforts to reduce the use of allogenic blood transfusion in orthopaedic surgery. Tranexamic acid, an anti-fibrinolytic agent, has been used in management of blood during surgery. In order to determine the impact of tranexamic acid in reducing blood loss among patients undergoing acetabular ORIF, investigators will conduct a prospective randomized study. Patients undergoing acetabular surgery will be screened for this study. Patients will be then randomized to placebo or tranexamic acid which will be administered during and after surgery. The following data will be collected: patient characteristics, surgery information, blood loss, blood transfusions, wound complication within 30 days of surgery, and cost.

详细描述

In this study, investigators plan to prospectively determine the effect of tranexamic acid on blood loss and outcome after surgery to the acetabulum.

Patients will be randomized into two groups. In this study, investigators plan to administer a 10mg/kg dose within 30 minutes of surgery followed by a 10mg/kg infusion over a 4hr period to the treatment group (for patients weighting over 100kg, a weight of 100kg will be used for the dose calculation). The control group will receive equal volumes of and rates of normal saline.

Research Questions:

  1. Do patients undergoing acetabular ORIF who receive tranexamic acid have a reduced risk of allogenic blood transfusion as compared to patients who receive placebo?
  2. Do patients undergoing acetabular ORIF who receive tranexamic acid have reduced peri-operative blood loss as compared to patients who receive placebo?
  3. Do patients undergoing acetabular ORIF who receive tranexamic acid have a higher risk for thromboembolic events than patients who receive placebo?
  4. Do patients undergoing acetabular ORIF who receive tranexamic acid have a reduced risk of wound complications (prolonged wound drainage, return to the OR within 30 days, infection)?
  5. Is the use of tranexamic acid cost effective relative to the use of allogenic blood transfusion as a blood loss management strategy in acetabular ORIF?

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients aged 18 or above undergoing acetabular ORIF.

排除标准

  • All patients aged below 18 years undergoing acetabulum surgery
  • Patients with color-blindness (color vision changes used to assess toxicity)
  • Patients with subarachnoid hemorrhage.
  • Patients with active intravascular coagulation.
  • Patients with a previous history of venous thromboembolism or with a history of hypercoaguable conditions (i.e. Factor V Leiden, antiphospholipid antibody).
  • Prisoners
  • Pregnant women

研究组 & 干预措施

Placebo

Placebo Comparator

Inactive

干预措施: Placebo (Drug)

Tranexamic

Active Comparator

Tranexamic acid: anti-fibrinolytic agents

干预措施: Tranexamic Acid (Drug)

结局指标

主要结局

Units of Packed Red Blood Cells Transfused

时间窗: perioperative

Average units packed red blood cells transfused among participants

Allogenic Blood Transfusion Rates

时间窗: post-operative

Number of participant received allogenic blood transfusions.

次要结局

  • Number of Participants With a Thromboembolic Event(30 days)
  • Estimate Blood Loss(perioperative)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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