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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Phase II trial of standard versus increased transfusion volume in Ugandan children with acute severe anemia
BMC Medicine, Volume 12, No. 1, Article 67, Year 2014
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Description
Background: Severe anemia (SA, hemoglobin <6 g/dl) is a leading cause of pediatric hospital admission in Africa, with significant in-hospital mortality. The underlying etiology is often infectious, but specific pathogens are rarely identified. Guidelines developed to encourage rational blood use recommend a standard volume of whole blood (20 ml/kg) for transfusion, but this is commonly associated with a frequent need for repeat transfusion and poor outcome. Evidence is lacking on what hemoglobin threshold criteria for intervention and volume are associated with the optimal survival outcomes.Methods: We evaluated the safety and efficacy of a higher volume of whole blood (30 ml/kg; Tx30: n = 78) against the standard volume (20 ml/kg; Tx20: n = 82) in Ugandan children (median age 36 months (interquartile range (IQR) 13 to 53)) for 24-hour anemia correction (hemoglobin >6 g/dl: primary outcome) and 28-day survival.Results: Median admission hemoglobin was 4.2 g/dl (IQR 3.1 to 4.9). Initial volume received followed the randomization strategy in 155 (97%) patients. By 24-hours, 70 (90%) children in the Tx30 arm had corrected SA compared to 61 (74%) in the Tx20 arm; cause-specific hazard ratio = 1.54 (95% confidence interval 1.09 to 2.18, P = 0.01). From admission to day 28 there was a greater hemoglobin increase from enrollment in Tx30 (global P <0.0001). Serious adverse events included one non-fatal allergic reaction and one death in the Tx30 arm. There were six deaths in the Tx20 arm (P = 0.12); three deaths were adjudicated as possibly related to transfusion, but none secondary to volume overload.Conclusion: A higher initial transfusion volume prescribed at hospital admission was safe and resulted in an accelerated hematological recovery in Ugandan children with SA. Future testing in a large, pragmatic clinical trial to establish the effect on short and longer-term survival is warranted.Please see related commentary article http://www.biomedcentral.com/1741-7015/12/68/abstract.Trial registration: ClinicalTrials.Gov identifier: NCT01461590 registered 26 October 2011. © 2014 Olupot-Olupot et al.; licensee BioMed Central Ltd.
Available Materials
https://efashare.b-cdn.net/share/pmc/articles/PMC4101869/bin/1741-7015-12-67-S1.doc
https://efashare.b-cdn.net/share/pmc/articles/PMC4101869/bin/1741-7015-12-67-S2.doc
Authors & Co-Authors
Olopot-Olupot, Peter Simon
Uganda, Mbale
Mbale Regional Referral Hospital
Engoru, Charles
Uganda, Eastern
Soroti Regional Referral Hospital
Thompson, Jennifer A.
United Kingdom, London
Mrc Clinical Trials Unit
Nteziyaremye, Julius
United Kingdom, London
Mrc Clinical Trials Unit
Chebet, Martin
Uganda, Mbale
Mbale Regional Referral Hospital
Ssenyondo, Tonny
Uganda, Mbale
Mbale Regional Referral Hospital
Dambisya, Cornelius M.
Uganda, Mbale
Mbale Regional Referral Hospital
Okuuny, Vicent
Uganda, Eastern
Soroti Regional Referral Hospital
Wokulira, Ronald
Uganda, Eastern
Soroti Regional Referral Hospital
Amorut, Denis
Uganda, Eastern
Soroti Regional Referral Hospital
Ongodia, Paul
Uganda, Mbale
Mbale Regional Referral Hospital
Mpoya, Ayub
Kenya, Nairobi
Wellcome Trust Research Laboratories Nairobi
Williams, Thomas Neil
Kenya, Nairobi
Wellcome Trust Research Laboratories Nairobi
United Kingdom, London
Wellcome Trust
Uyoga, Sophie M.
Kenya, Nairobi
Wellcome Trust Research Laboratories Nairobi
Macharia, Alex W.
Kenya, Nairobi
Wellcome Trust Research Laboratories Nairobi
Gibb, Diana M.
United Kingdom, London
Mrc Clinical Trials Unit
Walker, A. Sarah
United Kingdom, London
Mrc Clinical Trials Unit
Maitland, Kathryn M.
Kenya, Nairobi
Wellcome Trust Research Laboratories Nairobi
United Kingdom, London
Wellcome Trust
Statistics
Citations: 26
Authors: 18
Affiliations: 5
Identifiers
Doi:
10.1186/1741-7015-12-67
e-ISSN:
17417015
Research Areas
Environmental
Health System And Policy
Maternal And Child Health
Study Design
Randomised Control Trial