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CompletedNCT01580111Updated Apr 18, 2012

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

An interventional study of Blood transfusion in Compare Blood Age for Transfusion, sponsored by Makerere University. Completed at 1 site in Uganda. Open to participants aged 6 Months to 59 Months. Per ClinicalTrials.gov, last updated 2012-04-18.

Sponsored by Makerere University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
74
Allocation
Randomized
Ages
6 Months to 59 Months
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Compare Blood Age for Transfusion

Keywords

  • Blood
  • Storage
  • Age
  • Transfusion
  • Lactic acidosis
03

In context

Acidosis

194 studies on the registry are indexed under Acidosis; 31 are open to participants now.

This study's enrollment of 74 is above the median of 53 across 124 interventional studies indexed under Acidosis.

Browse Acidosis studies →

Lead sponsor

Makerere University is the lead sponsor of 143 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 59 Months
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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.

Exclusion Criteria:

  1. Children undergoing transfusion with blood products other than packed cells.
  2. Children with known or concurrent cardiac disease.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
74 participants (actual)

Study arms

  • Experimental
    Short storage

    Short storage arm: Will receive blood (Packed red blood cells) of 1 (one) to 10 (ten) days in storage.

    Biological: Blood transfusion

  • Active comparator
    Long storage arm

    Will be transfused with blood ( packed red cells) of storage age 21- 35 days.

    Biological: Blood transfusion

Interventions

  • BiologicalBlood transfusion

    The short storage arm; children were transfused with packed red cells of storage age 1-10 days; while for the Long storage arm; were transfused with packed red cells of 21- 35 days in storage.

06

What researchers measure

Primary outcomes

  1. Effect of blood storage age on the resolution of lactic acidosis in children with severe malarial anemia at Mulago hospital

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

    Time frame: 4hrs

Secondary outcomes

  1. Effect of blood storage age on the resolution of lactic acidosis in children with severe malarial anemia at Mulago hospital

    proportion of children who die within 24 hrs.

    Time frame: 24 HRS

07

Study locations

1 site
  • Mulago Hospital
    Kampala, 256, Uganda
08

References and documents

Publications

  • Dhabangi A, Mworozi E, Lubega IR, Cserti-Gazdewich CM, Maganda A, Dzik WH. The effect of blood storage age on treatment of lactic acidosis by transfusion in children with severe malarial anaemia: a pilot, randomized, controlled trial. Malar J. 2013 Feb 6;12:55. doi: 10.1186/1475-2875-12-55. PubMed 23388470 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01580111
Lead sponsor
Makerere University
Responsible party
Faculty of Medicine (Teaching Assistant, Makerere University) — Principal investigator
First posted
Apr 18, 2012
Start date
Dec 2010
Primary completion
Aug 2011
Completion
Nov 2011
Last update
Apr 18, 2012

Study contacts

AGGREY DHABANGI, MBChB, M.Med
principal investigator · Makerere University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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