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N Engl J Med. 2019 Aug 1;381(5):420-431. doi: 10.1056/NEJMoa1900100.

Transfusion Volume for Children with Severe Anemia in Africa.

Author information

1
From the Department of Medicine (K.M., T.N.W.) and Nutrition Research Section (G.F.), Imperial College London, and the Medical Research Council Clinical Trials Unit at University College London (E.C.G., D.M.G., A.S.W.), London, the School of Medicine, Dentistry, and Biomedical Science, Queen's University, Belfast (N.K.), the Liverpool School of Tropical Medicine and Hygiene, Liverpool (I.B.), the Department of Pediatrics, University Hospital of Wales, Cardiff (J.A.E.), and the Centre for Health Economics, University of York, York (P.S.G.) - all in the United Kingdom; Busitema University Faculty of Health Sciences, Mbale Campus, Mbale Regional Referral Hospital (P.O.-O., J.N., C.N.), and the Mbale Blood Transfusion Services (B.W.), Mbale, the Department of Pediatrics, Makerere University and Mulago Hospital (S.K., R.O.O., J.K.), and the Uganda Blood Transfusion Services, National Blood Transfusion Services (D.K.B.), Kampala, and Soroti Regional Referral Hospital, Soroti (F.A., C.E., M.N.) - all in Uganda; the Kenya Medical Research Institute-Wellcome Trust Research Program, Kilifi (K.M., A.M., S.U., T.N.W.); and the College of Medicine and the Malawi-Liverpool-Wellcome Trust Clinical Research Program (G.C., M.M., N.K.) and the Malawi Blood Transfusion Services (B.M.) - all in Blantyre, Malawi.

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.).

PMID:
31365800
DOI:
10.1056/NEJMoa1900100
[Indexed for MEDLINE]

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