Comparison of Two Tranexamic Acid Dose Regimens on Postoperative Bleeding and Transfusion Needs in Primary Valve Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 175
- 试验地点
- 1
- 主要终点
- Frequency of allogeneic red blood cells transfused
研究概览
简要总结
Cardiac surgical procedures account for a large amount of allogeneic transfusion. Tranexamic acid (TA), a synthetic antifibrinolytic drug, has been shown to reduce blood loss and transfusion requirements in cardiac surgery with Cardiopulmonary bypass. There are currently multiple dosing regimens for TA in cardiac surgery. Preliminary dose-response study has shown that low dose of TA would be as hemostatic efficacy as higher dose. Currently, no randomized study focus on TA in primary valve surgery. The aim of this prospective, double-blinded, randomized trial is to compare two dosing regimens of TA during primary valve surgery on perioperative blood loss and allogeneic blood transfusion.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •valvular disease patients requiring valvular replacement or repair surgery with cardiopulmonary bypass (CPB)
排除标准
- •a history of bleeding disorders
- •active chronic hepatitis or cirrhosis
- •chronic renal insufficiency (serum creatinine > 2 mg/dl)
- •preoperative anemia (Hb < 10 g/dl)
- •previous cardiac surgery
- •urgent and emergency surgery
研究组 & 干预措施
High dosage
A loading dose of 30 mg/kg and a maintenance infusion of 16 mg/kg through out the operation, and 2 mg/kg into the cardiopulmonary bypass (CPB) prime volume.
干预措施: Tranexamic Acid (Drug)
Low dosage
A loading dose of 10 mg/kg and a maintenance infusion of 1 mg/kg through out the operation, and 1 mg/kg into the cardiopulmonary bypass (CPB) prime volume.
干预措施: Tranexamic Acid (Drug)
结局指标
主要结局
Frequency of allogeneic red blood cells transfused
时间窗: 7 days post-operation
次要结局
- Chest tube drainage(24 hours post-operation)
研究者
Guyan Wang
Associate Professor
Chinese Academy of Medical Sciences, Fuwai Hospital