Dose Effect of Tranexamic Acid on the Incidence of Deep Venous Thrombus in Cardiac Surgery With Cardiopulmonary Bypass
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- The incidence of deep venous thrombosis
研究概览
简要总结
In recent years, the lysine analogs tranexamic acid (TXA) has gained wide use in cardiac surgery as a blood-sparing agent. However, the safety of the drug and its impact on overall outcomes of cardiac surgery remains debated. The current study evaluates the dose effect of TXA on the incidence of deep venous thrombus (DVT) in cardiac surgery with cardiopulmonary bypass. Also, the dose effect of TXA on bleeding and allogeneic transfusion is evaluated.
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)
盲法说明
The allocation is masked for the participant, care provider, investigator and 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
- •Patients receiving selective cardiac surgery with cardiopulmonary bypass due to coronary, valvular or congenital heart disease
- •Written consent obtained
排除标准
- •Allergy or contraindication to tranexamic acid
- •Severe renal impairment (serum creatinine >250 μmol/l, or estimated creatinine clearance <25 ml/min)
- •Thromboembolic disease including but not limited to: history of pulmonary embolism, spontaneous arterial thrombosis or familial hypercoaguability (eg. Lupus anticoagulant, protein C deficiency)
- •Thrombocytopenia defined as a platelet count <100,000/ml
- •Coagulopathy defined as an international normalized ratio > 1.5 prior to surgery
- •Currently enrolled in another perioperative interventional study
- •Pregnancy or lactation
研究组 & 干预措施
Dose group 1
The dose regimen of tranexamic acid in group 1 includes a loading dose of 30mg/kg before skin incision and a maintenance dose of 20mg/kg/hr until the end of the operation.
干预措施: Tranexamic Acid (Drug)
Dose group 2
The dose regimen of tranexamic acid in group 2 includes a loading dose of 20mg/kg before skin incision and a maintenance dose of 15mg/kg/hr until the end of the operation.
干预措施: Tranexamic Acid (Drug)
Dose group 3
The dose regimen of tranexamic acid in group 3 includes a loading dose of 10mg/kg before skin incision and a maintenance dose of 10mg/kg/hr until the end of the operation.
干预措施: Tranexamic Acid (Drug)
结局指标
主要结局
The incidence of deep venous thrombosis
时间窗: Within 7 days postoperatively
Defined as the incidence of new-onset deep venous thrombosis postoperatively diagnosed by ultrasound
次要结局
- The rate of allogeneic RBC transfusion(Within 30 days postoperatively)
- Length of stay in ICU and hospital(Within 90 days postoperatively)
- The volume of allogeneic RBC transfusion(Within 30 days postoperatively)
- The rate of new-onset thrombotic events(Within 90 days postoperatively)
研究者
SHI Jia
Associate Professor and Vice Chair of the Anesthesiology Department
Chinese Academy of Medical Sciences, Fuwai Hospital