Tranexamic Acid in Hip Fracture Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Total amount of blood loss per patient from admission to day 5 post-op
研究概览
简要总结
This is a randomized controlled trial comparing the use of tranexamic acid to placebo in patients admitted to hospital with a hip fracture.
详细描述
- transfusion of allogeneic RBC's is not free of adverse events and has been associated with an increased risk of postoperative infection
- Tranexamic acid in trauma patients has been shown to reduce 30-day mortality. Hospital trauma protocol includes tranexamic acid in patients with major bleeding.
- Tranexamic acid in orthopedic elective joint reconstruction surgery has been shown to substantially decrease bleeding in knee and hip arthroplasty.
- in hip fracture surgery, transexamic acid reduces erythrocyte transfusion rate but may promote a hypercoagulable state.
- Tranexamic acid is an antifibrinolytic drug that inhibits plasminogen from turning into plasmin thereby inhibiting clot breakdown.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Patients admitted to the emergency room with proximal hip fractures (31A-31B according to the Muller AO classification of fractures - long bones).
- •Patients mentally capable of giving informed consent.
排除标准
- •Vascular events within the last 2 months such as CVA, TIA, ACS, MI, DVT or arterial thrombosis.
- •Patients receiving anticoagulation therapy with Coumadin or Plavix.
- •Pregnancy and breastfeeding females.
- •Previous arterial or venous thrombosis
- •History of seizures.
- •Creatinine >
- •Oestroprogestive therapy.
- •Multiple fractures.
研究组 & 干预措施
Group A
Patients will receive IV Tranexamic acid 1 gram upon diagnosis and consent in the emergency room. A second 1 gram in a slow drip during the next 8 hours.
干预措施: Tranexamic acid (Drug)
GROUP B
Patients will receive IV Tranexamic acid 1 gram five minutes before skin incision and a second 1 gram in a slow drip during the next 8 hours.
干预措施: Tranexamic acid (Drug)
GROUP C
A control group will only receive placebo in the emergency room and in the OR.
干预措施: Tranexamic acid (Drug)
结局指标
主要结局
Total amount of blood loss per patient from admission to day 5 post-op
时间窗: 5 DAYS
次要结局
- 30 day mortality rate(30 days)
- Initial functional outcome and feeling of well-being.(5 days)
- thromboembolic events(5 days)
- Number of packed cell transfusion per patient.(5 DAYS)
- post-operative bacterial infection(5 days)
研究者
Michal Roll PhD,MBA
division of research and development TASMC
Tel-Aviv Sourasky Medical Center