Comparison of Three Tranexamic Acid Dose Regimens in Patients Undergoing Cardiac Valve Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- total postoperative drainage
研究概览
简要总结
This study compares the effect of three different dose levels of tranexamic acid（TXA）in reducing blood loss and transfusion requirements in cardiac valve surgery.
详细描述
The effect of TXA to reduce perioperative blood loss and blood transfusion has been well established in many trials, but the optimal dosage of TXA in cardiac surgery has always been a problem of debate. This is a single-center randomized controlled trial to study different dose regimens of TXA in cardiac surgery. We use three different dose levels of TXA in cardiac valve surgery with CPB, and see if there are any differences in perioperative blood loss and transfusion requirements. Serious adverse events and seizure attacks are also recorded until three months after 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged between 18 to 60 years old scheduled for cardiac valve surgery (replacement or plasty) requiring CPB
排除标准
- •known allergy to TXA, combined CABG operation or other cardiac procedures other than valve surgery, previous cardiac surgery, EF<45% or cardiothoracic ratio>0.65, serious coagulation disorder, serious hepatic insufficiency, receiving antiplatelet therapy at any time within 7 days of surgery, receiving low molecular weight heparin at any time within 24 hours of surgery, and pregnancy.
研究组 & 干预措施
low-dose group,
A bolus of 10 mg/kg Tranexamic Acid followed by a maintenance dose of 10 mg/kg/h Tranexamic Acid until the end of surgery
干预措施: Tranexamic acid (Drug)
middle-dose group,
A bolus of 20 mg/kg Tranexamic Acid followed by a maintenance dose of 15 mg/kg/h Tranexamic Acid until the end of surgery
干预措施: Tranexamic acid (Drug)
high-dose group
A bolus of 30 mg/kg Tranexamic Acid followed by a maintenance dose of 20 mg/kg/h Tranexamic Acid until the end of surgery
干预措施: Tranexamic acid (Drug)
结局指标
主要结局
total postoperative drainage
时间窗: from the operation day to the discharge，an average of 7 days
The total chest tube drainage postoperatively
次要结局
- Red blood cells transfusion rate（%），Red blood cells transfusion volume（ml）(from the operation day to the discharge，an average of 7 days)
- Fresh frozen plasma transfusion rate（%），Fresh frozen plasma transfusion volume（ml）(from the operation day to the discharge，an average of 7 days)
- Platelet transfusion rate（%），Platelet transfusion volume（ml）(from the operation day to the discharge，an average of 7 days)
- repeat surgery because of bleeding(from the operation day to the discharge，an average of 7 days)
- rate of death(from the operation day to three months after surgery)
- seizure attack(from the operation day to three months after surgery)
- length of stay in ICU and hospital(from the operation day to the discharge，an average of 7 days)
研究者
SHI Jia
Director，the department of Anesthesiology
Chinese Academy of Medical Sciences, Fuwai Hospital