Phase II trial of standard versus increased transfusion volume in Ugandan children with acute severe anemia


Severe anemia (SA, hemoglobin

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 35.5 months (interquartile range (IQR) 12.5 to 52.5)) 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

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.

Author: Peter Olupot-OlupotCharles EngoruJennifer ThompsonJulius NteziyaremyeMartin ChebetTonny SsenyondoCornelius M DambisyaVicent OkuunyRonald WokuliraDenis AmorutPaul OngodiaAyub MpoyaThomas N WilliamsSophie UyogaAlex MachariaDiana M GibbA Sarah Walker

Published on: 2014-04-25

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