Phase II Trial of Transfusion Volumes in Children With Acute Severe Anaemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Correction of severe anaemia.
研究概览
简要总结
Greater volume of whole blood(30mls/kg compared to 20mls/kg) following standard calculations, given to children with severe anaemia will be beneficial in haematological correction and can be given safely since respiratory distress and haemodynamic changes result from acidosis and compensation in these children rather than from biventricular failure.
详细描述
Severe anemia (SA, hemoglobin <6 g/dl) is a leading cause of pediatric hospital admission in Africa, with significant in-hospital mortality. The underlying etiology is often infectious, but specific pathogens are rarely identified. Guidelines developed to encourage rational blood use recommend a standard volume of whole blood (20 ml/kg) for transfusion, but this is commonly associated with a frequent need for repeat transfusion and poor outcome. Evidence is lacking on what haemoglobin threshold criteria for intervention and volume are associated with the optimal survival outcomes.
We evaluated the safety and efficacy of a higher volume of whole blood (30 ml/kg; Tx30: n = 78) against the standard volume (20 ml/kg; Tx20: n = 82) in Ugandan children (median age 35.5 months (interquartile range (IQR) 12.5 to 52.5)) for 24-hour anemia correction (hemoglobin >6 g/dl: primary outcome) and 28-day survival.
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
- 60 Days 至 12 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe anaemia(HB less than 6g/dl)at admission
- •Guardian or parent willing/able to provide consent
排除标准
- •Malignancy
- •Acute trauma
- •Severe malnutrition
研究组 & 干预措施
30ml/kg of whole blood
Higher volume than currently recommended
干预措施: Whole blood (Other)
20ml/kg of whole blood transfusion
Standard care recommended by WHO
干预措施: Whole blood (Other)
结局指标
主要结局
Correction of severe anaemia.
时间窗: 24 hours
Correction of severe anaemia to a Hb \>6g/dL at 24 hours.
次要结局
未报告次要终点
研究者
Prof Kathryn Maitland
Professor in Infectious Diseases and Critical Care
KEMRI-Wellcome Trust Collaborative Research Program
