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临床试验/NCT01064167
NCT01064167已完成不适用

Tranexamic Acid Reduces Blood Loss After Off-pump Coronary Artery Bypass Grafting

Chinese Academy of Medical Sciences, Fuwai Hospital1 个研究点 分布在 1 个国家目标入组 231 人开始时间: 2009年2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
231
试验地点
1
主要终点
Number of Patients Required Allogenic Red Blood Cells Transfusion

研究概览

简要总结

The aim of this prospective, randomized, double-blinded, placebo-controlled study was to evaluate the effects of tranexamic acid, a synthetic antifibrinolytic drug, on the postoperative bleeding and transfusion requirements in patients undergoing off-pump coronary artery bypass graphing (OPCAB) surgery.

详细描述

Cardiac surgical procedures account for a large amount of allogeneic transfusion. Although postoperative bleeding seems to be attenuated by the avoidance of cardiopulmonary bypass (CPB), hemorrhagic complications are not completely eliminated and the consequent need for allogeneic transfusions are still major problems after OPCAB.

Tranexamic acid, a synthetic antifibrinolytic drug, has been shown to reduce blood loss and transfusion requirements in cardiac surgery with CPB. About 30% of patients in OPCAB studies still receive a transfusion. A few small sample size studies concerned with the use of in OPCAB surgery, found that tranexamic acid appear to be effective in reducing postoperative bleeding, however, the results on transfusion requirements are still inconsistency. The purpose of this study was to evaluate the effects of tranexamic acid on the postoperative bleeding and transfusion requirements in a larger number of patients undergoing OPCAB surgery. In addition, the effect of tranexamic acid on mortality, morbidity and resource utilization was examined.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients for elective offpump coronary artery bypass surgery

排除标准

  • A history of bleeding disorders
  • Active chronic hepatitis or cirrhosis
  • Chronic renal insufficiency (serum creatinine > 2 mg/dL)
  • Preoperative anemia (Hb < 10 g/dL)
  • Previous cardiac surgery
  • Myocardial infarction < 7 days before surgery

研究组 & 干预措施

Tranexamic Acid group

Experimental

干预措施: Tranexamic Acid (Drug)

Control group

Placebo Comparator

干预措施: Tranexamic Acid (Drug)

结局指标

主要结局

Number of Patients Required Allogenic Red Blood Cells Transfusion

时间窗: 1month postoperative

次要结局

  • Postoperative Chest Tube Drainage(24h postoperative)

研究者

发起方
Chinese Academy of Medical Sciences, Fuwai Hospital
申办方类型
Other

研究点 (1)

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