Phase II trial of standard versus increased transfusion volume in Ugandan children with acute severe anemia.
- Olupot-Olupot, Peter
- Engoru, Charles
- Thompson, Jennifer
- Nteziyaremye, Julius
- Chebet, Martin
- Ssenyondo, Tonny
- Dambisya, Cornelius M
- Okuuny, Vicent
- Wokulira, Ronald
- Amorut, Denis
- Ongodia, Paul
- Mpoya, Ayub
- Williams, Thomas N
- Uyoga, Sophie
- Macharia, Alex
- Gibb, Diana M
- Walker, A Sarah
- Maitland, Kathryn
DOIAbstract
BACKGROUND: 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 ...
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