Hemostatic Effects of Ulinastatin and Tranexamic Acid in Cardiac Surgery With Cardiopulmonary Bypass: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 426
- 试验地点
- 1
- 主要终点
- Postoperative blood loss
研究概览
简要总结
Antifibrinolytic drugs are used to decrease perioperative bleeding and allogeneic transfusions. The extensively studied antifibrinolytic drug aprotinin is efficacious but expensive, and has been proved to link to higher risks of serious side effects including renal problems, myocardial events, and strokes in patients undergoing CABG. After the secession of aprotinin in 2007, a marked increase of blood loss and transfusions in cardiac surgery took place. An effective and secure hemostatic agent is badly needed. Ulinastatin, urinary trypsin inhibitor(UTI), is a secreted Kunitz-type protease inhibitor with a wide inhibition spectrum, including plasmin. Limited studies offered clues to its antifibrinolytic effect. Tranexamic acid has been applied for years with convinced efficacy and safety. The objective of the study is to evaluate the hemostatic effect of ulinastatin and tranexamic acid in 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
- •Atrial or ventricular septum defect patients requiring cardiac surgery with CPB
- •Rheumatic or recessive valvular patients requiring valvular repair or replacement with CPB
- •Coronary artery disease patients requiring coronary revascularization surgery with CPB
排除标准
- •Non-primary cardiac surgery
- •Definite liver or renal dysfunction
- •Disorder in coagulation function
- •Pregnancy or lactation
- •Disabled in spirit or law
- •Fatal conditions such as tumour
研究组 & 干预措施
Ulinastatin
1,000,000 units of ulinastatin in 50ml solution before skin incision; 50ml saline solution after neutralization
干预措施: Ulinastatin (Drug)
Tranexamic Acid
15mg/kg tranexamic acid in 50ml solution before skin incision; 15mg/kg tranexamic acid in 50ml solution after neutralization
干预措施: Tranexamic Acid (Drug)
Placebo
50ml saline solution before skin incision; 50ml saline solution after neutralization
干预措施: Saline Solution (Drug)
结局指标
主要结局
Postoperative blood loss
时间窗: Postoperatively
Defined as the total volume of chest drainage postoperatively
次要结局
- Rate of reexploration for bleeding(Postoperatively)
- Rate of major bleeding(Perioperatively)
- Transfusion of allogeneic erythrocytes(Perioperatively)
- Transfusion of fresh frozen plasma (FFP)(Perioperatively)
- Transfusion of allogeneic platelets(Perioperatively)
- Length of stay in ICU and hospital postoperatively(Postoperatively)
研究者
SHI Jia
Associated Professor and Vice Chair of department of anesthesiology, Fuwai Hospital, NCCD, PUMC & CAMS
Chinese Academy of Medical Sciences, Fuwai Hospital