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Immediate Transfusion in African Children with Uncomplicated Severe Anemia

Maitland, Kathryn, Kiguli, Sarah, Olupot-Olupot, Peter, Engoru, Charles, Mallewa, Macpherson, Saramago Goncalves, Pedro, Opoka, Robert O., Mpoya, Ayub, Alaroker, Florence, Nteziyaremye, Julius, Chagaluka, George, Kennedy, Neil, Nabawanuka, Eva, Nakuya, Margaret, Namayanja, Cate, Uyoga, Sophie, Kyeyune Byabazaire, Dorothy, M’baya, Bridon, Wabwire, Benjamin, Frost, Gary, Bates, Imelda ORCID: https://orcid.org/0000-0002-0862-8199, Evans, Jennifer A., Williams, Thomas N., George, Elizabeth C., Gibb, Diana M. and Walker, A. Sarah (2019) 'Immediate Transfusion in African Children with Uncomplicated Severe Anemia'. New England Journal of Medicine, Vol 381, Issue 5, pp. 407-419.

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Abstract

Background

The World Health Organization recommends not performing transfusions in African children hospitalized for uncomplicated severe anemia (hemoglobin level of 4 to 6 g per deciliter and no signs of clinical severity). However, high mortality and readmission rates suggest that less restrictive transfusion strategies might improve outcomes.

Methods

In this factorial, open-label, randomized, controlled trial, we assigned Ugandan and Malawian children 2 months to 12 years of age with uncomplicated severe anemia to immediate transfusion with 20 ml or 30 ml of whole-blood equivalent per kilogram of body weight, as determined in a second simultaneous randomization, or no immediate transfusion (control group), in which transfusion with 20 ml of whole-blood equivalent per kilogram was triggered by new signs of clinical severity or a drop in hemoglobin to below 4 g per deciliter. The primary outcome was 28-day mortality. Three other randomizations investigated transfusion volume, postdischarge supplementation with micronutrients, and postdischarge prophylaxis with trimethoprim–sulfamethoxazole.

Results

A total of 1565 children (median age, 26 months) underwent randomization, with 778 assigned to the immediate-transfusion group and 787 to the control group; 984 children (62.9%) had malaria. The children were followed for 180 days, and 71 (4.5%) were lost to follow-up. During the primary hospitalization, transfusion was performed in all the children in the immediate-transfusion group and in 386 (49.0%) in the control group (median time to transfusion, 1.3 hours vs. 24.9 hours after randomization). The mean (±SD) total blood volume transfused per child was 314±228 ml in the immediate-transfusion group and 142±224 ml in the control group. Death had occurred by 28 days in 7 children (0.9%) in the immediate-transfusion group and in 13 (1.7%) in the control group (hazard ratio, 0.54; 95% confidence interval [CI], 0.22 to 1.36; P=0.19) and by 180 days in 35 (4.5%) and 47 (6.0%), respectively (hazard ratio, 0.75; 95% CI, 0.48 to 1.15), without evidence of interaction with other randomizations (P>0.20) or evidence of between-group differences in readmissions, serious adverse events, or hemoglobin recovery at 180 days. The mean length of hospital stay was 0.9 days longer in the control group.

Conclusions

There was no evidence of differences in clinical outcomes over 6 months between the children who received immediate transfusion and those who did not. The triggered-transfusion strategy in the control group resulted in lower blood use; however, the length of hospital stay was longer, and this strategy required clinical and hemoglobin monitoring.

Item Type: Article
Subjects: WB Practice of Medicine > Therapeutics > WB 356 Blood transfusion
WH Hemic and Lymphatic Systems > Hematologic Diseases. Immunologic Factors. Blood Banks > WH 155 Anemia
WH Hemic and Lymphatic Systems > Hematologic Diseases. Immunologic Factors. Blood Banks > WH 460 Blood bank procedures
WS Pediatrics > Diseases of Children and Adolescents > By System > WS 300 Hemic and lymphatic system
Faculty: Department: Clinical Sciences & International Health > International Public Health Department
Digital Object Identifer (DOI): https://doi.org/10.1056/NEJMoa1900105
Depositing User: Rachel Dominguez
Date Deposited: 22 Aug 2019 15:37
Last Modified: 22 Aug 2019 15:37
URI: https://archive.lstmed.ac.uk/id/eprint/11466

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