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

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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 ; Urban, Britta ; von Hensbroek, Michael Boele ; Heyderman, Robert ; Thomason, Margaret J ; Uyoga, Sophie ; Williams, Thomas N ; Gibb, Diana M ; George, Elizabeth C ; Walker, A Sarah ; Maitland, Kathryn (2015)
  • Publisher: BioMed Central
  • Journal: (vol: 16)
  • Related identifiers: pmc: PMC4696199, doi: 10.1186/s13063-015-1112-4
  • Subject: Medicine (miscellaneous) | wb_356 | ws_300 | ws_366 | Africa | Anaemia | Emergency medicine | 1102 Cardiovascular Medicine And Haematology | Transfusion | Malaria | General & Internal Medicine | 1103 Clinical Sciences | Children | wh_155 | Antibiotic prophylaxis | Study Protocol | Micronutrients | Haemoglobinopathies | Sepsis | Pharmacology (medical)

Background\ud 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.\ud \ud Methods/Design\ud 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.\ud \ud 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.\ud \ud Discussion\ud 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.\ud \ud Trial registration\ud Current Controlled Trials ISRCTN84086586, Approved 11 February 2013
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