Prospective Randomized Controlled Clinical Trial Comparing a Restrictive Versus Liberal Transfusion Strategy in Neonates and Infants Undergoing Surgery for Congenital Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- oxygen utilization derived from the arterio-venous oxygen difference.
研究概览
简要总结
In neonates and infants </= 10 kg following cardiac surgery for congenital heart disease a more restrictive red blood cell (RBC) transfusion strategy will be as effective as, and possibly superior to, a liberal RBC strategy. Allowing lower hemoglobin concentration will not affect the cardiac or pulmonary status of the patient.
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
- None
入排标准
- 年龄范围
- — 至 7 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children </= 6 months of age with congenital cardiac disease undergoing cardiac surgery with cardiopulmonary bypass.
排除标准
- •presence of a known bleeding disorder or coagulopathy.
- •age > 6 months,
- •lack of informed consent.
研究组 & 干预措施
Restrictive transfusion strategy
RBC will be transfused if the hemoglobin level falls below 7 for bi-ventricular repairs and under 9.0 for single ventricle palliations.
干预措施: Red blood cell transfusion (Other)
Liberal RBC transfusion strategy
RBCs will be transfused for Hemoglobin under 9.5 for biventricular repairs and under 12 for single ventricle palliations.
干预措施: Red blood cell transfusion (Other)
结局指标
主要结局
oxygen utilization derived from the arterio-venous oxygen difference.
时间窗: 3 days
Arterial and venous oxygen saturations will be measured every four hours x 48-72 hours and will be used to calculate arterio-venous oxygen content differences.
次要结局
- volume of RBC transfused(7 days)
研究者
jill cholette
Assistant Professor of Pediatrics
University of Rochester