NCT01586923已完成3 期
A Prospective Study of RBC Transfusion in Children With Severe Anemia
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 290
- 试验地点
- 1
- 主要终点
- Reduction of elevated levels of blood lactate during 24 following RBC transfusion
研究概览
简要总结
The hypothesis of this study is that prolonged-storage RBCs are not inferior to short-storage RBCs for the time required to clear elevated blood lactate levels in children with severe anemia.
详细描述
This study will measure the time to resolution of lactic acidosis in patients with severe anemia following blood transfusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 6 mos to 5 years
- •Hg < 5 g/dL and Lactate > 5 mM
排除标准
- •Receiving transfusion other than RBCs
- •Children with known or suspected cardiac disease
结局指标
主要结局
Reduction of elevated levels of blood lactate during 24 following RBC transfusion
时间窗: 24 hours
次要结局
- Correction of acidosis(24 hours)
- Normalization of vital signs(24 hours)
研究者
Walter H. Dzik
Co-Director, Blood Transfusion Service
Massachusetts General Hospital
研究点 (1)
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