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

Not Applicable

Completed

• Conditions: Compare Blood Age for Transfusion
• Interventions: Biological: Blood transfusion

• Registration Number: NCT01580111
• Lead Sponsor: Makerere University

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 Description

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.

Study Timeline

• Study Start: 2010-12
• Primary Completion: 2011-08
• Study Completion: 2011-11
• Status Verified: 2012-04
• Study First Submitted: 2012-04-17
• Study First Submitted QC: 2012-04-17
• Last Update Submitted: 2012-04-17
• Study First Posted: 2012-04-18
• Last Update Posted: 2012-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

Children aged 6 - 59 months admitted at Acute care Unit - Mulago hospital with;

1. A positive B/S for malaria
2. Severe anemia ( Hb ≤ 5 g/dl) and
3. Lactic Acidosis (Blood lactate ≥ 5 mmol/l)
4. Written informed consent from the caretaker.

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Exclusion Criteria

1. Children undergoing transfusion with blood products other than packed cells.
2. Children with known or concurrent cardiac disease.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Short storage	Blood transfusion	Short storage arm: Will receive blood (Packed red blood cells) of 1 (one) to 10 (ten) days in storage.
Long storage arm	Blood transfusion	Will be transfused with blood ( packed red cells) of storage age 21- 35 days.

Primary Outcome Measures

Name	Time	Method
Effect of blood storage age on the resolution of lactic acidosis in children with severe malarial anemia at Mulago hospital	4hrs	The proportion of transfused patients who resolve lactic acidosis within 4 hours of transfusion

Secondary Outcome Measures

Name	Time	Method
Effect of blood storage age on the resolution of lactic acidosis in children with severe malarial anemia at Mulago hospital	24 HRS	proportion of children who die within 24 hrs.

Trial Locations

Locations (1)

Mulago Hospital; 🇺🇬 Kampala, Uganda