Effect of Blood Storage Age on the Resolution of Lactic Acidosis in Children With Severe Malarial Anemia at Mulago Hospital
1 other identifier
interventional
74
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 17, 2012
CompletedFirst Posted
Study publicly available on registry
April 18, 2012
CompletedApril 18, 2012
April 1, 2012
8 months
April 17, 2012
April 17, 2012
Conditions
Keywords
Outcome Measures
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
4hrs
Secondary Outcomes (1)
Effect of blood storage age on the resolution of lactic acidosis in children with severe malarial anemia at Mulago hospital
24 HRS
Study Arms (2)
Short storage
EXPERIMENTALShort storage arm: Will receive blood (Packed red blood cells) of 1 (one) to 10 (ten) days in storage.
Long storage arm
ACTIVE COMPARATORWill be transfused with blood ( packed red cells) of storage age 21- 35 days.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Children undergoing transfusion with blood products other than packed cells.
- Children with known or concurrent cardiac disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mulago Hospital
Kampala, Uganda, 256, Uganda
Related Publications (1)
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.
PMID: 23388470DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
AGGREY DHABANGI, MBChB, M.Med
Makerere University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Teaching Assistant
Study Record Dates
First Submitted
April 17, 2012
First Posted
April 18, 2012
Study Start
December 1, 2010
Primary Completion
August 1, 2011
Study Completion
November 1, 2011
Last Updated
April 18, 2012
Record last verified: 2012-04