Transfusion and Treatment of severe anaemia in African children (TRACT): a study protocol for a randomised controlled trial. Issue 1 (December 2015)

• Record Type: Journal Article
• Authors: Mpoya, Ayub; Kiguli, Sarah; Olupot-Olupot, Peter; Opoka, Robert; Engoru, Charles; Mallewa, Macpherson; Chimalizeni, Yami; Kennedy, Neil; Kyeyune, Dorothy; Wabwire, Benjamin; M'baya, Bridon; Bates, Imelda; Urban, Britta; von Hensbroek, Michael; Heyderman, Robert; Thomason, Margaret; Uyoga, Sophie; Williams, Thomas; Gibb, Diana; George, Elizabeth; Walker, A.; Maitland, Kathryn
• Is Part Of: Trials. Volume 16:Issue 1(2015)
• Page Start: 1
• Page End: 15
• Publication Date: 2015-12
• Subjects: Children -- Africa -- Anaemia -- Malaria -- Sepsis -- Transfusion -- Micronutrients -- Emergency medicine -- Haemoglobinopathies -- Antibiotic prophylaxis; Group-randomized trials -- Periodicals; Randomized Controlled Trials -- Periodicals; 615.0727
• DOI: 10.1186/s13063-015-1112-4
• Languages: English
• ISSNs: 1745-6215

Abstract

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 TrialsISRCTN84086586, Approved 11 February 2013