NCT06254404尚未招募不适用
Impact of Protamine Dose Reduction on Platelet Aggregation After Extracorporeal Circulation for Minimally Invasive Aortic Valve Replacement Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Minimum effective dose of protamine after extracorporeal circulation. A bottom-up and top-down method will define CP 50.
研究概览
简要总结
Determining the minimum effective dose of protamine after extracorporeal circulation for mini-sternotomy aortic valve replacement surgery.
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
- Single (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
- •Mini-sternotomy aortic valve replacement surgery
- •Major patients
排除标准
- •Hypersensitivity to protamine
- •Coagulation Abnormalities
- •Heparin allergy
- •Pregnant women
- •Jehovah's Witnesses
研究组 & 干预措施
Low dose of Protamine
Active Comparator
干预措施: Low dose protamine (Drug)
Normal dose of protamine
Experimental
干预措施: Low dose protamine (Drug)
结局指标
主要结局
Minimum effective dose of protamine after extracorporeal circulation. A bottom-up and top-down method will define CP 50.
时间窗: 24 hours
次要结局
未报告次要终点
研究者
Benjamin Javillier, MD
Principal Investigator
University of Liege
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