Comparison of Tranexamic to Epsilon Aminocaproic Acid: a Prospective Analysis of Blood Conservation in Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Total Transfusion Amounts
研究概览
简要总结
We designed a prospective double-blinded randomized trial in an attempt to detect a difference between tranexamic acid (TXA) and epsilon aminocaproic acid (EACA) in reducing transfusion in patients undergoing cardiac surgery.
详细描述
Background: This study compares the efficacy of tranexamic acid (TXA) to epsilon aminocaproic acid (EACA) in reducing blood loss in patients undergoing cardiac surgery. Methods: This was a double-blinded randomized trial. Patients (n=100) undergoing cardi- ac surgery were randomized to receive either TXA (10 mg/kg bolus followed by an infu- sion of 1mg/kg/hr) or EACA (150mg/kg bolus followed by an infusion of 20 mg/kg/hr). The primary outcome measure was a difference in transfusion amounts.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Is the subject 18 years of age or older?
- •Is the subject scheduled for primary cardiac surgery utilizing cardiopulmonary bypass(CPB)?
- •Is the subject more than 30 kg ( 66 lbs)?
- •Does subject understand English?
排除标准
- •Does the subject have existing coagulation defects (INR > 1.5, platelets < 100 ?
- •Does the subject have renal failure (defined as BUN/Cr ratio 20:1 ?
- •Does the subject have severe liver disease (AST & ALT> 3x normal) ?
- •Is the subject having emergency cardiac surgery, complex aortic surgery, combination valve/CABG surgeries, or redo cardiac surgery?
- •Is the subject having any procedure where CPB is not anticipated?
- •Is the patient weight greater than 150 kg?
研究组 & 干预措施
Tranexamic Acid
The research pharmacist used computer randomization to assign patients to receive either TXA or EACA. The TXA group re- ceived a bolus of 10 mg / kg over 15 minutes fol- lowed by an infusion of 1 mg/kg/hr.
干预措施: Tranexamic Acid (Drug)
Aminocaproic Acid
The research pharmacist used computer randomization to assign patients to receive either TXA or EACA. The EACA group received a bolus of 100 mg / kg given over 15 minutes shortly after induction of anesthesia followed by an infusion of 10 mg/kg/hr.
干预措施: Aminocaproic Acid (Drug)
结局指标
主要结局
Total Transfusion Amounts
时间窗: 48 hours
The outcome measure was the intergroup difference in total transfusion amounts up to post-operative day 2.
次要结局
未报告次要终点
研究者
Jason Gatling, MD
MD
Loma Linda University