Transfusion and Treatment of severe anaemia in African children (TRACT): a study protocol for a randomised controlled trial

Mpoya, Ayub, Kiguli, Sarah, Olupot-Olupot, Peter, Opoka, Robert O, Engoru, Charles, Mallewa, Macpherson, Chimalizeni, Yami, Kennedy, Neil, Kyeyune, Dorothy, Wabwire, Benjamin, M'baya, Bridon, Bates, Imelda ORCID: https://orcid.org/0000-0002-0862-8199, Urban, Britta ORCID: https://orcid.org/0000-0002-4197-8393, von Hensbroek, Michael Boele, Heyderman, Robert, Thomason, Margaret J, Uyoga, Sophie, Williams, Thomas N, Gibb, Diana M, George, Elizabeth C, Walker, A Sarah and Maitland, Kathryn (2015) 'Transfusion and Treatment of severe anaemia in African children (TRACT): a study protocol for a randomised controlled trial'. Trials, Vol 16, Issue 593.

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Abstract

Background
In sub-Saharan Africa, where infectious diseases and nutritional deficiencies are common, severe anaemia is a common cause of paediatric hospital admission, yet the evidence to support current treatment recommendations is limited. To avert overuse of blood products, the World Health Organisation advocates a conservative transfusion policy and recommends iron, folate and anti-helminthics at discharge. Outcomes are unsatisfactory with high rates of in-hospital mortality (9–10 %), 6-month mortality and relapse (6 %). A definitive trial to establish best transfusion and treatment strategies to prevent both early and delayed mortality and relapse is warranted.

Methods/Design
TRACT is a multicentre randomised controlled trial of 3954 children aged 2 months to 12 years admitted to hospital with severe anaemia (haemoglobin < 6 g/dl). Children will be enrolled over 2 years in 4 centres in Uganda and Malawi and followed for 6 months. The trial will simultaneously evaluate (in a factorial trial with a 3 x 2 x 2 design) 3 ways to reduce short-term and longer-term mortality and morbidity following admission to hospital with severe anaemia in African children.

The trial will compare: (i) R1: liberal transfusion (30 ml/kg whole blood) versus conservative transfusion (20 ml/kg) versus no transfusion (control). The control is only for children with uncomplicated severe anaemia (haemoglobin 4–6 g/dl); (ii) R2: post-discharge multi-vitamin multi-mineral supplementation (including folate and iron) versus routine care (folate and iron) for 3 months; (iii) R3: post-discharge cotrimoxazole prophylaxis for 3 months versus no prophylaxis. All randomisations are open. Enrolment to the trial started September 2014 and is currently ongoing. Primary outcome is cumulative mortality to 4 weeks for the transfusion strategy comparisons, and to 6 months for the nutritional support/antibiotic prophylaxis comparisons. Secondary outcomes include mortality, morbidity (haematological correction, nutritional and infectious), safety and cost-effectiveness.

Discussion
If confirmed by the trial, a cheap and widely available ‘bundle’ of effective interventions, directed at immediate and downstream consequences of severe anaemia, could lead to substantial reductions in mortality in a substantial number of African children hospitalised with severe anaemia every year, if widely implemented.

Trial registration
Current Controlled Trials ISRCTN84086586, Approved 11 February 2013

Item Type:	Article
Uncontrolled Keywords:	Children; Africa; Anaemia; Malaria; Sepsis; Transfusion; Micronutrients; Emergency medicine; Haemoglobinopathies; Antibiotic prophylaxis
Subjects:	WB Practice of Medicine > Therapeutics > WB 356 Blood transfusion WH Hemic and Lymphatic Systems > Hematologic Diseases. Immunologic Factors. Blood Banks > WH 155 Anemia WS Pediatrics > Diseases of Children and Adolescents > By System > WS 300 Hemic and lymphatic system WS Pediatrics > Pediatric Specialities > WS 366 Pediatric Therapeutics
Faculty: Department:	Clinical Sciences & International Health > International Public Health Department Biological Sciences > Department of Tropical Disease Biology
Digital Object Identifer (DOI):	https://doi.org/10.1186/s13063-015-1112-4
Depositing User:	Jessica Jones
Date Deposited:	28 Jan 2016 15:36
Last Modified:	22 Oct 2019 08:23
URI:	https://archive.lstmed.ac.uk/id/eprint/5556

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