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Transfusion Volume for Children with Severe Anemia in Africa

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Title: Transfusion Volume for Children with Severe Anemia in Africa
Authors: Maitland, K
Olupot-Olupot, P
Kiguli, S
Chagaluka, G
Alaroker, F
Opoka, RO
Mpoya, A
Engoru, C
Nteziyaremye, J
Mallewa, M
Kennedy, N
Nakuya, M
Namayanja, C
Kayaga, J
Uyoga, S
Byabazaire, DK
M'baya, B
Wabwire, B
Frost, G
Bates, I
Evans, JA
Williams, TN
Goncalves, PS
George, EC
Gibb, DM
Walker, AS
Item Type: Journal Article
Abstract: Background Severe anemia (hemoglobin level, <6 g per deciliter) is a leading cause of hospital admission and death in children in sub-Saharan Africa. The World Health Organization recommends transfusion of 20 ml of whole-blood equivalent per kilogram of body weight for anemia, regardless of hemoglobin level. Methods In this factorial, open-label trial, we randomly assigned Ugandan and Malawian children 2 months to 12 years of age with a hemoglobin level of less than 6 g per deciliter and severity features (e.g., respiratory distress or reduced consciousness) to receive immediate blood transfusion with 20 ml per kilogram or 30 ml per kilogram. Three other randomized analyses investigated immediate as compared with no immediate transfusion, the administration of postdischarge micronutrients, and postdischarge prophylaxis with trimethoprim–sulfamethoxazole. The primary outcome was 28-day mortality. Results A total of 3196 eligible children (median age, 37 months; 2050 [64.1%] with malaria) were assigned to receive a transfusion of 30 ml per kilogram (1598 children) or 20 ml per kilogram (1598 children) and were followed for 180 days. A total of 1592 children (99.6%) in the higher-volume group and 1596 (99.9%) in the lower-volume group started transfusion (median, 1.2 hours after randomization). The mean (±SD) volume of total blood transfused per child was 475±385 ml and 353±348 ml, respectively; 197 children (12.3%) and 300 children (18.8%) in the respective groups received additional transfusions. Overall, 55 children (3.4%) in the higher-volume group and 72 (4.5%) in the lower-volume group died before 28 days (hazard ratio, 0.76; 95% confidence interval [CI], 0.54 to 1.08; P=0.12 by log-rank test). This finding masked significant heterogeneity in 28-day mortality according to the presence or absence of fever (>37.5°C) at screening (P=0.001 after Sidak correction). Among the 1943 children (60.8%) without fever, mortality was lower with a transfusion volume of 30 ml per kilogram than with a volume of 20 ml per kilogram (hazard ratio, 0.43; 95% CI, 0.27 to 0.69). Among the 1253 children (39.2%) with fever, mortality was higher with 30 ml per kilogram than with 20 ml per kilogram (hazard ratio, 1.91; 95% CI, 1.04 to 3.49). There was no evidence of differences between the randomized groups in readmissions, serious adverse events, or hemoglobin recovery at 180 days. Conclusions Overall mortality did not differ between the two transfusion strategies. (Funded by the Medical Research Council and Department for International Development, United Kingdom; TRACT Current Controlled Trials number, ISRCTN84086586. opens in new tab.)
Issue Date: 1-Aug-2019
Date of Acceptance: 17-Jun-2019
URI: http://hdl.handle.net/10044/1/72729
DOI: https://dx.doi.org/10.1056/NEJMoa1900100
ISSN: 0028-4793
Publisher: Massachusetts Medical Society
Start Page: 420
End Page: 431
Journal / Book Title: New England Journal of Medicine
Volume: 381
Issue: 5
Copyright Statement: © 2019 Massachusetts Medical Society. All rights reserved.
Sponsor/Funder: Medical Research Council
Medical Research Council, UK
Medical Research Council (MRC)
Medical Research Council
Funder's Grant Number: MR/J012483/1
MR/J012483/1
MR/J012483/1
MR/J012483/1
Keywords: Science & Technology
Life Sciences & Biomedicine
Medicine, General & Internal
General & Internal Medicine
Anemia
Blood Transfusion
Child
Child, Preschool
Cost-Benefit Analysis
Female
Fever
Follow-Up Studies
Health Care Costs
Hemoglobins
Humans
Infant
Length of Stay
Malaria
Malawi
Male
Patient Readmission
Transfusion Reaction
Uganda
TRACT Group
Humans
Malaria
Anemia
Fever
Hemoglobins
Blood Transfusion
Length of Stay
Patient Readmission
Follow-Up Studies
Child
Child, Preschool
Infant
Cost-Benefit Analysis
Health Care Costs
Uganda
Malawi
Female
Male
Transfusion Reaction
Science & Technology
Life Sciences & Biomedicine
Medicine, General & Internal
General & Internal Medicine
General & Internal Medicine
11 Medical and Health Sciences
Publication Status: Published
Online Publication Date: 2019-08-01
Appears in Collections:Department of Infectious Diseases