Effects of Antifibrinolytics on Bleeding and Transfusion Outcomes in Patients Receiving Coronary Artery Bypass Surgery With Preoperative Clopidogrel Exposure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 552
- 试验地点
- 7
- 主要终点
- Postoperative blood loss(chest drainage)
研究概览
简要总结
The use of platelet aggregation inhibitors, including aspirin and clopidogrel(CPDG), has become a standard management strategy for patients with acute coronary syndrome. On this background, an increasing percentage of patients presenting for surgical coronary revascularization is the subject to irreversible platelet inhibition.
Investigations on the effect of antiplatelet treatment on postoperative bleeding after cardiac surgery have shown that patients treated with antiplatelet agents until surgery have increased postoperative bleeding, and also an increased need for transfusions of blood products. As a result of the antiplatelet effect of clopidogrel, the frequency of serious bleeding complications has increased significantly, as seen in patients requiring coronary artery bypass grafting(CABG), especially when they received clopidogrel until surgery.
Tranexamic acid(TA) is a widely used antifibrinolytic agent, and is a promising substitute for aprotinin when the latter has seceded in 2007.The release of plasmin during cardiopulmonary bypass(CPB) activates fibrinolysis and may contribute to platelet dysfunction. Pharmacological inhibition of the fibrinolytic system may therefore ameliorate platelet dysfunction and fibrinolysis after CPB and decrease postoperative bleeding. Tranexamic acid prevents plasmin formation and inhibits fibrinolysis.
Concerning the cessation of aprotinin and the increasing proportion of patients with persistence on clopidogrel until their surgery, evolutional work is expected, especially in the eastern population.
The purpose of this study is to assess the effect of tranexamic acid in patients with clopidogrel and asprin ingestion until surgery. The investigators working hypothesis was that tranexamic acid would lower postoperative blood loss and transfusion requirements in these patients and would attenuate bleeding complication of antiplatelet therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients requiring primary and isolated coronary artery bypass grafting with cardiopulmonary bypass
排除标准
- •history of cardiac surgery
- •hematocrit <33%
- •platelet count <100,000/ml
- •allergy to tranexamic acid
- •recruited in other studies
研究组 & 干预措施
group LP
Patients receiving late CABG >7 days of the cessation of clopidogrel, treated with placebo(saline solution)
干预措施: Saline (Drug)
group ET
Patients receiving early CABG <=7 days of the cessation of clopidogrel, treated with tranexamic acid with a bolus of 10 mg/kg after anesthetic induction and a maintenance of 10 mg/kg/h for the duration of surgery.
干预措施: Tranexamic Acid (Drug)
group EP
Patients receiving early CABG <= 7 days of the cessation of clopidogrel, treated with placebo(saline solution)
干预措施: Saline (Drug)
group LT
Patients receiving late CABG >7 days of the cessation of clopidogrel, treated with tranexamic acid with a bolus of 10 mg/kg after anesthetic induction and a maintenance of 10 mg/kg/h for the duration of surgery.
干预措施: Tranexamic Acid (Drug)
group BT
Patients receiving CABG without preoperative clopidogrel exposure, treated with tranexamic acid with a bolus of 10 mg/kg after anesthetic induction and a maintenance of 10 mg/kg/h for the duration of surgery.
干预措施: Tranexamic Acid (Drug)
group BP
Patients receiving CABG without preoperative clopidogrel exposure, treated with placebo(saline solution)
干预措施: Saline (Drug)
结局指标
主要结局
Postoperative blood loss(chest drainage)
时间窗: on the 120th day postoperatively
Incidence of major bleeding
时间窗: on the 120th day postoperatively
RBC Transfusion (volume and rate)
时间窗: on the 120th day postoperatively
次要结局
- Mortality(on the 120th day postoperatively)
- Major morbidity(on the 120th day postoperatively)
研究者
Li Lihuan
Professor and directior of the department of anaesthesiology, Cardiovascular Institute and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union M
Chinese Academy of Medical Sciences, Fuwai Hospital
