Preoperative Tranexamic Acid (TXA) to Prevent Bleeding in Patients Undergoing Major Colorectal Surgery
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 394
- 试验地点
- 2
- 主要终点
- Perioperative change in hemoglobin
研究概览
简要总结
The goal of this prospective pragmatic randomized clinical trial is to determine if preoperative administration of tranexamic acid (TXA) reduces bleeding during and after major colorectal surgery. The primary questions are:
- Does TXA reduce bleeding during and after surgery (change in hemoglobin from before surgery to lowest value after surgery within 30 days)
- Does TXA reduce bleeding complications within 30 days of surgery (blood transfusion, return to the operating room or procedural intervention for bleeding, death due to bleeding)
- Does TXA increase the risk of thromboembolic complications within 30 days of surgery (cerebrovascular accident, myocardial infarction, deep venous thrombosis, pulmonary embolism)
Researchers will compare preoperative TXA to no TXA to answer the above questions.
Participants who receive TXA will receive 1 g TXA IV at the beginning and end of surgery in the operating room.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Pragmatic (non-blinded)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18 years or older
- •Undergoing elective or non-elective inpatient abdominal and pelvic colorectal surgery
排除标准
- •Creatinine clearance less than 30 mL/minute
- •Long-term dialysis
- •Known defective color vision (color blind)
- •History of venous or arterial thromboembolism, or active thromboembolic disease
- •Disseminated intravascular coagulation (DIC) - clinically suspected and/or confirmed by platelet count on CBC, fibrinogen, INR and PTT.
研究组 & 干预措施
Tranexamic Acid
TXA administered as a 1 gram IV bolus in 100ml of normal saline administered over 10 minutes at the start and end of the surgery for a total of 2 grams TXA
干预措施: Tranexamic acid (Drug)
结局指标
主要结局
Perioperative change in hemoglobin
时间窗: 60 days
Preoperative to lowest postoperative within 30 days of surgery
次要结局
- Rate of composite bleeding complication(Within 30 days postop)
- Rate of composite thromboembolic event(Within 30 days postop)
研究者
Kristen Ban
Assistant Professor of Surgery
The Cleveland Clinic