Biomaterial Database

Immediate Transfusion in African Children with Uncomplicated Severe Anemia. 2019

Kathryn Maitland, and Sarah Kiguli, and Peter Olupot-Olupot, and Charles Engoru, and Macpherson Mallewa, and Pedro Saramago Goncalves, and Robert O Opoka, and Ayub Mpoya, and Florence Alaroker, and Julius Nteziyaremye, and George Chagaluka, and Neil Kennedy, and Eva Nabawanuka, and Margaret Nakuya, and Cate Namayanja, and Sophie Uyoga, and Dorothy Kyeyune Byabazaire, and Bridon M'baya, and Benjamin Wabwire, and Gary Frost, and Imelda Bates, and Jennifer A Evans, and Thomas N Williams, and Elizabeth C George, and Diana M Gibb, and A Sarah Walker, and

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

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. 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. 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. 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. (Funded by the Medical Research Council and Department for International Development; TRACT Current Controlled Trials number, ISRCTN84086586.).

UI	MeSH Term	Description	Entries
D007223	Infant	A child between 1 and 23 months of age.	Infants
D007902	Length of Stay	The period of confinement of a patient to a hospital or other health facility.	Hospital Stay,Hospital Stays,Stay Length,Stay Lengths,Stay, Hospital,Stays, Hospital
D008288	Malaria	A protozoan disease caused in humans by four species of the PLASMODIUM genus: PLASMODIUM FALCIPARUM; PLASMODIUM VIVAX; PLASMODIUM OVALE; and PLASMODIUM MALARIAE; and transmitted by the bite of an infected female mosquito of the genus ANOPHELES. Malaria is endemic in parts of Asia, Africa, Central and South America, Oceania, and certain Caribbean islands. It is characterized by extreme exhaustion associated with paroxysms of high FEVER; SWEATING; shaking CHILLS; and ANEMIA. Malaria in ANIMALS is caused by other species of plasmodia.	Marsh Fever,Plasmodium Infections,Remittent Fever,Infections, Plasmodium,Paludism,Fever, Marsh,Fever, Remittent,Infection, Plasmodium,Plasmodium Infection
D008295	Malawi	A republic in southern Africa east of ZAMBIA and MOZAMBIQUE. Its capital is Lilongwe. It was formerly called Nyasaland.	Nyasaland,Republic of Malawi
D008297	Male		Males
D010359	Patient Readmission	Subsequent admissions of a patient to a hospital or other health care institution for treatment.	Hospital Readmission,Rehospitalization,Unplanned Hospital Readmissions,Unplanned Readmission,30 Day Readmission,Hospital Readmissions,Readmission, Hospital,Readmissions, Hospital,Thirty Day Readmission,30 Day Readmissions,Hospital Readmission, Unplanned,Hospital Readmissions, Unplanned,Readmission, Patient,Readmission, Thirty Day,Readmission, Unplanned,Rehospitalizations,Thirty Day Readmissions,Unplanned Hospital Readmission,Unplanned Readmissions
D001803	Blood Transfusion	The introduction of whole blood or blood component directly into the blood stream. (Dorland, 27th ed)	Blood Transfusions,Transfusion, Blood,Transfusions, Blood
D002648	Child	A person 6 to 12 years of age. An individual 2 to 5 years old is CHILD, PRESCHOOL.	Children
D002675	Child, Preschool	A child between the ages of 2 and 5.	Children, Preschool,Preschool Child,Preschool Children
D003362	Cost-Benefit Analysis	A method of comparing the cost of a program with its expected benefits in dollars (or other currency). The benefit-to-cost ratio is a measure of total return expected per unit of money spent. This analysis generally excludes consideration of factors that are not measured ultimately in economic terms. In contrast a cost effectiveness in general compares cost with qualitative outcomes.	Cost and Benefit,Cost-Benefit Data,Benefits and Costs,Cost Benefit,Cost Benefit Analysis,Cost-Utility Analysis,Costs and Benefits,Economic Evaluation,Marginal Analysis,Analyses, Cost Benefit,Analysis, Cost Benefit,Analysis, Cost-Benefit,Analysis, Cost-Utility,Analysis, Marginal,Benefit and Cost,Cost Benefit Analyses,Cost Benefit Data,Cost Utility Analysis,Cost-Benefit Analyses,Cost-Utility Analyses,Data, Cost-Benefit,Economic Evaluations,Evaluation, Economic,Marginal Analyses