ISRCTN66687527已完成1 期
An unmasked, single arm trial to assess harm, safety and efficacy of umbilical cord red blood cell transfusion for children with severe anaemia in a Kenyan hospital
iverpool School of Tropical Medicine (UK)0 个研究点目标入组 80 人开始时间: 2007年7月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Children aged 12 years or less, either sex
- •2. Children with severe anaemia for whom a blood transfusion is indicated (aged less than three months, Haemoglobin [Hb] less than or equal to 10 g/dL; aged greater than three months, Hb less than or equal to 4 g/dL)
排除标准
- •1. Coma (Blantyre Coma Scale less than or equal to 2)
- •2. Prostration (if unable to sit when well, inability to take enteral feeds; if able to sit when well, inability to sit unsupported)
- •3. Uncompensated shock
- •4. Compensated shock (capillary refill time greater than 3 seconds; temperature gradient)
- •5. Respiratory distress (deep breathing)
- •6. Neonatal hyperbilirubinaemia requiring exchange transfusion
- •7. Any other marker of clinical severity considered to preclude the child from recruitment into the study
- •8. Enrolment in another intervention trial
- •9. Children for whom informed consent to enter the study is not possible or not given
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