跳至主要内容
临床试验/NCT01060163
NCT01060163已完成不适用

Effects of Antifibrinolytics on Bleeding and Transfusion Outcomes in Patients Receiving Coronary Artery Bypass Surgery With Preoperative Clopidogrel Exposure

Chinese Academy of Medical Sciences, Fuwai Hospital7 个研究点 分布在 1 个国家目标入组 552 人开始时间: 2010年1月最近更新:
适应症
干预措施
相关药物

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

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

Placebo Comparator

Patients receiving late CABG >7 days of the cessation of clopidogrel, treated with placebo(saline solution)

干预措施: Saline (Drug)

group ET

Experimental

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

Placebo Comparator

Patients receiving early CABG <= 7 days of the cessation of clopidogrel, treated with placebo(saline solution)

干预措施: Saline (Drug)

group LT

Experimental

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

Experimental

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

Placebo Comparator

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

发起方
Chinese Academy of Medical Sciences, Fuwai Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

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

研究点 (7)

Loading locations...

相似试验

Tranexamic Acid in Clopidogrel Exposure to Decrease... | 临床试验