NCT00646373终止不适用
Effect of Decreased Pump Prime Volume on Blood Transfusions and Postoperative Complications of Patients Undergoing High Risk Cardiac Surgical Procedures: A Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 50
- 主要终点
- The number of units of blood products transfused within the first 24 hours post CPB.
研究概览
简要总结
The objective of this study is to evaluate the impact of reduced pump prime on blood transfusions and postoperative complications in patients at high risk of severe hemodilution during CPB.
HYPOTHESIS The use of a new CPB circuit with a smaller internal volume, together with retrograde autologous priming of the lines (RAP) will allow a smaller prime volume and therefore less significant hemodilution on pump.
EXPERIMENTAL DESIGN Overview
Patients will be randomized on the morning of surgery to one of the two study groups in a 1:1 allocation scheme:
- Low pump prime
- Standard pump prime Outcomes The primary outcome is the number of units of blood products transfused within the first 24 hours post CPB.
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
- Single (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
- •>18 y of age
- •Non-emergent complex cardiac surgery (any procedure other than primary isolated CABG)
- •Any of the following: Hb < 120 g/L (Females) or < 130 g/L (Males)BSA < 1.6 m2Creatinine Clearance < 60 mL/min (Cockcroft Gault Equation)
排除标准
- •aPTT >50 s, INR>1.5
- •Plt < 100,000 x 106
- •Preoperative Hemodialysis
- •Tight aortic stenosis (Aortic Valve Area < 1 cm2)
- •Tight lesion of the left main coronary artery (> 60%)
- •Use of Aprotinin requested by the Surgical Team
结局指标
主要结局
The number of units of blood products transfused within the first 24 hours post CPB.
时间窗: 24 hours
次要结局
未报告次要终点
研究者
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