Fibrinolysis Before Cardiopulmonary Bypass?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Di-Dimer Increase Before Cardiopulmonary Bypass
研究概览
简要总结
It is common practice to use antifibrinolytic agents before and during cardiopulmonary bypass. They are not without side effects. The investigators want to show that there is no proof of fibrinolysis in standard sternotomy cardiac surgery patients before cardiopulmonary bypass, and that antifibrinolytic agents should only be started on cardiopulmonary bypass.
详细描述
Double-blind, placebo controlled, prospective study in two groups of 20 patients. Control group (A) receives standard Epsilonaminocaproic acid treatment before cardiopulmonary bypass (10 gr loading dose, and 1 gr/hr infusion), and second group (B) receives placebo. Before start of Epsilonaminocaproic acid/placebo, D-Dimers and Thromboelastography are measured, repeated just before full heparinization. After heparinization group A receives placebo, and group B Epsilonaminocaproic acid.
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
- Triple (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
- •All adult patients, undergoing first time sternotomy for Coronary artery bypass grafting/Aortic valve replacement/aortic surgery
排除标准
- •Resternotomy, renal insufficiency, deep hypothermia, age < 18 yrs
研究组 & 干预措施
Epsilonaminocaproic acid
One arm: Epsilonaminocaproic acid 10 gr IV, followed by 1 gr/hr infusion Second arm: placebo
干预措施: Epsilonaminocaproic acid (Drug)
Placebo, Antifibrinolytic activity
Placebo: same IV volume as experimental arm
干预措施: Placebo (Drug)
结局指标
主要结局
Di-Dimer Increase Before Cardiopulmonary Bypass
时间窗: 6 months
Change in Di-dimer between preoperative value and value immediately before cardiopulmonary bypass in cardiac surgery patients.
次要结局
- Value of Thromboelastography as Monitor of Fibrinolysis(6 months)