Tranexamic Acid Reduces Blood Loss After Off-pump Coronary Artery Bypass Grafting
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
- 否
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
干预措施: Tranexamic Acid (Drug)
Control group
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)
