AProtinin Versus Tranexamic Acid in Cardiac Surgery Patients With High-risk for Excessive Bleeding
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 693
- 试验地点
- 7
- 主要终点
- Proportion of patients with severe peri-operative bleeding
研究概览
简要总结
In this before-after multicenter study the authors tested the hypothesis that the prophylactic use of aprotinin compared to tranexamic acid could reduce the proportion of patients presenting severe perioperative bleeding.
详细描述
Perioperative bleeding remains a real challenge for physicians managing cardiac surgical patients. In patients at high risk for excessive bleeding the prophylactic use of antifibrinolytics may be useful. This study propose to compare the efficacity and innocuity of aprotinin and tranexamic acid to reduce the proportion of patient presenting severe peri-operative bleeding according the Universal Definition of Perioperative Bleeding (UDPB) classification.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing cardiac on pump surgery at high risk for bleeding defined by :
- •Aorto-coronary bypasses surgery (2 or more) under dual platelet aggregation therapy (Primary or redo)
- •Heart transplant (Primary or Redo)
- •Infectious endocarditis (Primary or Redo)
- •Ascending acute aortic dissection (Primary or Redo)
- •Artificial heart / LVAD under CEC (Primary or Redo)
- •Combined surgery, Redo
- •Ascending aorta surgery, Redo
排除标准
- •Off pump cardiac surgery
- •Patient not meeting the inclusion criteria
- •Patient not receiving antifibrinolytic therapy
- •Patient with absolute contraindication to antifibrinolytics,
- •Patient refusing to give access to their medical chart,
- •Patient not meeting the inclusion criteria
- •Patient protected by the law, under guardianship or trusteeship,
- •Patient deprived of liberty
结局指标
主要结局
Proportion of patients with severe peri-operative bleeding
时间窗: day 30 after surgery
Proportion of patients with severe peri-operative bleeding defined by an UDPB (the Universal Definition of Perioperative Bleeding ) classification of 3 and 4.
次要结局
- distribution of patients by UDPB classification category(day 30 after surgery)
- blood loss(24 hours after chest closure)
- rescue surgery for bleeding(day 30 after surgery)
- length of stay(through hospital discharge, an average of 30 days)
- mechanical ventilation(48 hours after surgery)
- new renal replacement therapy(up to day 30 after surgery)
- mechanical ventilation time(through intensive care unit discharge, an average of 30 days)
- KDIGO score greater than or equal to 2(day 7 after surgery)
- need for vasopressors/inotropes(beyond 24 hours after surgery)
- vital status(30 days after surgery)
- myocardial infarction(up to 30 day after surgery)
- need for transfusion(up to seven day after surgery)
- short term mechanical circulatory support(up to 30 day after surgery)
- embolic or thrombotic event(up to 30 day after surgery)
- stroke(up to 30 day after surgery)