A Randomized Double-blinded Trial to Explore the Optimum Dose of Tranexamic Acid in Cardiopulmonary Bypass Cardiac Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 955
- 试验地点
- 1
- 主要终点
- Postoperative Blood Loss
研究概览
简要总结
Tranexamic acid, an antifibrinolytic drug, is wildly used in cardiac surgeries to decrease perioperative bleeding and allogenic transfusion. But the optimum dose of tranexamic acid is still unknown. We use three different doses to find which is the optimum dose of tranexamic acid in cardiopulmonary bypass cardiac surgery.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Noncyanotic congenital heart disease patients requiring cardiac surgeries under cardiopulmonary bypass
- •Rheumatic or recessive valvular disease patients requiring valvular repair or replacement under cardiopulmonary bypass
- •Coronary artery disease patients requiring coronary artery bypass graft under cardiopulmonary bypass
排除标准
- •Non-primary and emergency cardiac surgery
- •Disorder in coagulation function before surgery
- •Anemia before surgery
- •Definite liver and renal dysfunction
- •History of stroke
- •Pregnancy and lactation
- •Disabled in spirit or law
- •Fatal conditions such as cancer
研究组 & 干预措施
small dose
10mg/kg tranexamic acid add in priming fluid, 10mg/kg single shot slowly when incision, followed by 2mg/(kg·h) infusion until the end of surgery
干预措施: Tranexamic Acid (Drug)
medium dose
20mg/kg tranexamic acid add in priming fluid, 20mg/kg single shot slowly when incision, followed by 4mg/(kg·h) infusion until the end of surgery
干预措施: Tranexamic Acid (Drug)
large dose
30mg/kg tranexamic acid add in priming fluid, 30mg/kg single shot slowly when incision, followed by 6mg/(kg·h) infusion until the end of surgery
干预措施: Tranexamic Acid (Drug)
结局指标
主要结局
Postoperative Blood Loss
时间窗: 24hrs postoperatively
次要结局
- Number of Participants Needs Allogenic Transfusion(on the 7th day postoperatively)
研究者
Hongwen Ji
professor of medicine
Chinese Academy of Medical Sciences, Fuwai Hospital