Three Dose Regimen of Tranexamic Acid on Blood Loss and Allogeneic Transfusions in Cardiac Surgery With Cardiopulmonary Bypass
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Rate of exposure to allogeneic erythrocytes transfusions
研究概览
简要总结
Tranexamic acid is thought to be a promising substitute for aprotinin when the latter has seceded in 2007. Yet the ideal dosage and dosing regimen of tranexamic acid in cardiopulmonary bypass cardiac surgery in Chinese population remains controversial. The current study includes patients receiving valvular replacement and coronary artery bypass surgery. Three dosage regimen of tranexamic acid is delivered and blood loss, transfusions and clinical outcomes are recorded.
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
- •Rheumatic or recessive valvular disease patients requiring valvular replacement surgery with cardiopulmonary bypass
- •Coronary artery disease patients requiring coronary artery bypass surgery with cardiopulmonary bypass
- •Wrriten consent obtained
排除标准
- •Non-primary cardiac surgery
- •Preoperative liver or renal dysfunction
- •Preoperative coagulation disorder
- •Pregnancy or lactation
- •Disabled in spirit or law
- •Fatal conditions such as tumour
研究组 & 干预措施
High dosage
Tranexamic acid with a loading dose of 30 mg/kg and a maintenance infusion of 20 mg/kg/h
干预措施: Tranexamic Acid (Drug)
Medium dosage
Tranexamic acid with a loading dose of 20 mg/kg and a maintenance infusion of 15 mg/kg/h
干预措施: Tranexamic Acid (Drug)
Low dosage
Tranexamic acid with a loading dose of 10 mg/kg and a maintenance infusion of 10 mg/kg/h
干预措施: Tranexamic Acid (Drug)
Control
Saline solution
干预措施: Saline Solution (Drug)
结局指标
主要结局
Rate of exposure to allogeneic erythrocytes transfusions
时间窗: Perioperatively
Allogeneic RBCs were transfused if the hemoglobin level was less than 6 g/dL during cardiopulmonary bypass, less than 8 g/dL postoperatively, or less than 9 g/dL for elderly people (\>70 years).
次要结局
- Rate and volume of fresh frozen plasma transfusion(Perioperatively)
- Rate and volume of allogeneic platelet transfusion(Perioperatively)
- Rate of reexploration for hemostasis(Perioperatively)
- Postoperative blood loss(Postoperatively)
- Thromboelastography(Perioperatively)
- Coagulatory and fibrinolytic associated moleculars(Perioperatively)
- Inflammation associated moleculars(Perioperatively)
- Length of stay in ICU and hospital postoperatively(Postoperatively)
- Volume of allogeneic erythrocytes transfusions(Perioperatively)
研究者
SHI Jia
Associate Professor and Vice Chair of the Department of Anesthesiology, Fuwai hospital, NCCD, PUMC & CAMS
Chinese Academy of Medical Sciences, Fuwai Hospital