Anticoagulant Effect and Reversal of Hepalean Compared With PPC Heparin in Patients Undergoing Cardiopulmonary Bypass: a Pilot Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Feasibility to conduct a larger trial
研究概览
简要总结
Heparin, a blood thinner, is used routinely in Open-heart surgery. Do different brands of this drug have differing clinical effects despite both having exactly the same regulation and marketing specifications?
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, 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
- •will be undergoing cardiopulmonary bypass for coronary artery disease
- •has provided written informed consent
排除标准
- •Allergy or intolerance to Heparin
研究组 & 干预措施
Hepalean Heparin
干预措施: Hepalean Heparin (Drug)
PPC Heparin
干预措施: PPC Heparin (Drug)
结局指标
主要结局
Feasibility to conduct a larger trial
时间窗: pre-cardiopulmonary bypass initiation; peri-operative period (in minutes) to 24 hours post-operatively
Will the pilot show that the pilot's design is feasible with respect to timely patient enrolment, blinding of treatment allocation, study drug dosage requirements and the collection and measurement of study outcomes; ACT of \> 450 seconds after initial pre-CPB heparin bolus, dosage of additional heparin (if any) to maintain an ACT of greater than 450 seconds, differences (if any) in coagulation profiles, differences if any in chest tube drainage, differences (if any) in post-operative transfusion requiements
次要结局
- ACT after initial dose of heparin(pre-cardiopulmonary bypass initiation; peri-operatively(in seconds))
- Total Heparin Dose used(pre-cardiopulmonary bypass initiation to termination of cardiopulmonary bypass; peri-operatively(in minutes))
- Coagulation(post-cardiopulmonary inition, at the 45 minute on pump time point; perioperatively to 24 hours post-operatively)