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临床试验/NCT01596738
NCT01596738已完成不适用

Tranexamic Acid in Patients Receiving Primary and Isolated On-pump CABG With Premature Clopidogrel Cessation to Reduce Postoperative Bleeding and Transfusion

Li Lihuan1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2008年10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
120
试验地点
1
主要终点
Allogeneic erythrocyte, volume transfused

研究概览

简要总结

The use of platelet aggregation inhibitors, including aspirin and clopidogrel, 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.

Tranexamic acid is a widely used antifibrinolytic agent, and is a promising substitute for aprotinin when the latter has been suspended in 2007.The release of plasmin during 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.

Many studies and meta-analyses have shown a reduction in postoperative bleeding and transfusion requirements of this antifibrinolytic drug in cardium revascularization surgery. Unfortunately the preoperative antiplatelet therapy was either neglected or obscure. Few studies specify the time between the last clopidogrel ingestion and surgery.Several studies were keen on the blood loss and allogeneic transfusion in patients who received their last clopidogrel or asprin within 7 days prior to coronary artery bypass grafting. Concerning the secession 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 less than 7 days prior to surgery. The working hypothesis is that tranexamic acid would reduce bleeding and transfusion requirements in this specific population of patients.

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 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women aged 18-85 years undergoing primary and isolated on-pump CABG
  • Last ingestion of clopidogrel and aspirin within 7 days preoperatively

排除标准

  • Previous cardiac surgery
  • Hematocrit <33%
  • Platelet count <100,000/ml
  • Allergy to tranexamic acid
  • Recruited in other studies

研究组 & 干预措施

Tranexamic Acid group

Experimental
  1. Tranexamic acid 50mg/ml, 15 mg/kg intravenous after anesthetic induction
  2. Tranexamic acid 50mg/ml, 15 mg/kg intravenous after neutralization

干预措施: Tranexamic Acid (Drug)

Placebo group

Placebo Comparator
  1. Equivalent volume of saline, equal to that of 50mg/ml tranexamic acid at the dosage of 15mg/kg, intravenous after anesthetic induction
  2. Equivalent volume of saline, equal to that of 50mg/ml tranexamic acid at the dosage of 15mg/kg, intravenous after neutralization

干预措施: Saline (Drug)

结局指标

主要结局

Allogeneic erythrocyte, volume transfused

时间窗: Participants will be followed for the duration of hospital stay, an expected average of 7 days

Total volume of allogeneic erythrocyte transfused, from the beginning of the operation until discharge

Allogeneic erythrocyte, percentage exposed

时间窗: Participants will be followed for the duration of hospital stay, an expected average of 7 days

The percentage of patients exposed to allogeneic erythrocyte, from the beginning of the operation until discharge

次要结局

  • Reoperation(Participants will be followed for the duration of hospital stay, an expected average of 7 days)
  • Blood loss(Participants will be followed for the duration of hospital stay, an expected average of 7 days)
  • Major bleeding(Participants will be followed for the duration of hospital stay, an expected average of 7 days)

研究者

发起方
Li Lihuan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Li Lihuan

Professor and director of the department of anesthesiology and critical care, NCCD, PUMC & CAMS

Chinese Academy of Medical Sciences, Fuwai Hospital

研究点 (1)

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