Effect of Blood Storage Age on the Resolution of Lactic Acidosis in Children With Severe Malarial Anemia at Mulago Hospital
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Effect of blood storage age on the resolution of lactic acidosis in children with severe malarial anemia at Mulago hospital
研究概览
简要总结
In resolving lactic acidosis among children with severe malarial anemia, there is no difference between those transfused with blood of longer storage compared to shorter storage age
详细描述
Objective of the study is to evaluate the effect of blood storage age on resolution of lactic acidosis in children with severe malarial anemia.
Methods:
Children aged 6 - 59 months admitted to ACU with Severe Malarial Anemia (Hb <5g/dl) and Lactic Acidosis (blood lactate >5 mmol /l), will be randomly assigned to receive either blood of shorter storage age (<10 days) or longer storage age (21 -35 days) by gravity infusion as is the routine practice. 37 patients will be enrolled in each study arm. Physiological measurements namely blood lactate, oxygen saturation, Hemoglobin, Blood pressure, respiratory rate and pulse rate will be taken at baseline, during and after transfusion. The two groups will be compared. The primary outcome variable will be the proportion of children whose lactic acidosis resolves after 4 hrs of transfusion. 24hr mortality will be our secondary outcome.
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
- Single (Care Provider)
入排标准
- 年龄范围
- 6 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 6 - 59 months admitted at Acute care Unit - Mulago hospital with;
- •A positive B/S for malaria
- •Severe anemia ( Hb ≤ 5 g/dl) and
- •Lactic Acidosis (Blood lactate ≥ 5 mmol/l)
- •Written informed consent from the caretaker.
排除标准
- •Children undergoing transfusion with blood products other than packed cells.
- •Children with known or concurrent cardiac disease.
结局指标
主要结局
Effect of blood storage age on the resolution of lactic acidosis in children with severe malarial anemia at Mulago hospital
时间窗: 4hrs
The proportion of transfused patients who resolve lactic acidosis within 4 hours of transfusion
次要结局
- Effect of blood storage age on the resolution of lactic acidosis in children with severe malarial anemia at Mulago hospital(24 HRS)
研究者
Faculty of Medicine
Teaching Assistant
Makerere University