Efficacy of Tranexamic Acid on Perioperative Blood Loss During Hip Fracture Surgery.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- number of patients receiving the transfusion of at least one unit of allogeneic red blood cell
研究概览
简要总结
The purpose of this study is to assess the efficacy of tranexamic acid in hip fracture surgery on the reduction of allogeneic red blood cell transfusion.
详细描述
Studies in hip and knee arthroplasty (scheduled surgery) have shown that tranexamic acid decreases allogeneic red blood cell transfusion. In hip fracture surgery, an emergent procedure, transfusion is frequent. Transfusion increases adverse events such as postoperative bacterial infection and venous thrombosis. The purpose of this study is to assess the efficacy of tranexamic acid, an anti-fibrinolytic agent, in hip fracture surgery on the reduction of allogeneic red blood cell transfusion. The trial will also evaluate if the reduction in transfusion will be associated with less postoperative infection and without an increase in the thrombotic risk.
Patients with an isolated hip fracture of less than 48 hours will be randomized to either tranexamic acid 15mg/kg IV at skin incision and three hours later or saline.Patients will receive fondaparinux for prophylaxis of venous thrombosis.
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
- Triple (Participant, Care Provider, 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
- 否
入选标准
- •Patient requiring surgery for an isolated hip fracture of less than 48 hours
排除标准
- •Contraindication to tranexamic acid
- •Contraindication to fondaparinux
- •Contraindication to general anesthesia associated with a femoral nerve block
- •pregnancy
研究组 & 干预措施
1
Exacyl
干预措施: Tranexamic acid (Exacyl) (Drug)
2
Physiologic serum
干预措施: Placebo (Drug)
结局指标
主要结局
number of patients receiving the transfusion of at least one unit of allogeneic red blood cell
时间窗: between the begining of surgery (day 1) and the eighth post-operative day (day 8)
次要结局
- number of patients receiving the transfusion of at least one unit of allogeneic red blood cell(between the administration of fondaparinux for venous thrombosis prophylaxis(8 hours after end of surgery on day 1) and the eighth post-operative day (day 8))
- post-operative major hemorrhage(day 8)
- post-operative blood loss(untill day 8)
- post-operative bacterial infection (combined criteria of wound infection, bronchopulmonary infection and urinary tract infection)(untill six weeks)
- thromboembolic events (combined criteria of venous thrombo-embolism, stroke, acute coronary syndrome and peripheral arterial thrombosis)(untill six weeks)