跳至主要内容
临床试验/NCT01461590
NCT01461590已完成2 期

Phase II Trial of Transfusion Volumes in Children With Acute Severe Anaemia

Prof Kathryn Maitland2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2011年10月1日最近更新:
适应症
干预措施

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

Experimental

Higher volume than currently recommended

干预措施: Whole blood (Other)

20ml/kg of whole blood transfusion

Active Comparator

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

发起方
Prof Kathryn Maitland
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Prof Kathryn Maitland

Professor in Infectious Diseases and Critical Care

KEMRI-Wellcome Trust Collaborative Research Program

研究点 (2)

Loading locations...

相似试验