Clinical Trial: Effect of Blood Storage Age on the Resolution of Lactic Acidosis in Children With Severe Malarial Anemia at Mulago Hospital

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effect of Blood Storage Age on the Resolution of Lactic Acidosis in Children With Severe Malarial Anemia at Mulago Hospital

Brief Summary: 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

Detailed Summary:

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.


Sponsor: Makerere University

Current Primary Outcome: Effect of blood storage age on the resolution of lactic acidosis in children with severe malarial anemia at Mulago hospital [ Time Frame: 4hrs ]

The proportion of transfused patients who resolve lactic acidosis within 4 hours of transfusion


Original Primary Outcome: Same as current

Current Secondary Outcome: Effect of blood storage age on the resolution of lactic acidosis in children with severe malarial anemia at Mulago hospital [ Time Frame: 24 HRS ]

proportion of children who die within 24 hrs.


Original Secondary Outcome: Same as current

Information By: Makerere University

Dates:
Date Received: April 17, 2012
Date Started: December 2010
Date Completion:
Last Updated: April 17, 2012
Last Verified: April 2012