Abstract
Phase II trial of standard versus increased transfusion volume in Ugandan children with acute severe anemia
Olupot-Olupot, P.
Engoru, C.
Thompson, J.
Nteziyaremye, J.
Chebet, M.
Ssenyondo, T.
Dambisya, C. M.
Okuuny, V.
Wokulira, R.
Amorut, D.
Ongodia, P.
Mpoya, A.
Williams, T. N.
Uyoga, S.
Macharia, A.
Gibb, D. M.
Walker, A. S.
Maitland, K.
BMC Med. 2014; 1267
Permanent descriptor
https://doi.org/10.1186/1741-7015-12-67BACKGROUND: Severe anemia (SA, 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. TRIAL REGISTRATION: ClinicalTrials.Gov identifier: NCT01461590 registered 26 October 2011.