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

Abstract

Severe anemia (SA, hemoglobin 6 g/dl: primary outcome) and 28-day survival. 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 P = 0.12); three deaths were adjudicated as possibly related to transfusion, but none secondary to volume overload. 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/ ClinicalTrials.Gov identifier: NCT01461590 registered 26 October 2011.