@article{Maitland:2015:10.1186/s13063-015-1112-4,
author = {Maitland, K},
doi = {10.1186/s13063-015-1112-4},
journal = {Trials},
title = {Transfusion and Treatment of severe anaemia in African children (TRACT): a study protocol for a randomized controlled trial},
url = {http://dx.doi.org/10.1186/s13063-015-1112-4},
volume = {16},
year = {2015}
}

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TY  - JOUR
AB  - BackgroundIn 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/DesignTRACT 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
AU  - Maitland,K
DO  - 10.1186/s13063-015-1112-4
PY  - 2015///
SN  - 1745-6215
TI  - Transfusion and Treatment of severe anaemia in African children (TRACT): a study protocol for a randomized controlled trial
T2  - Trials
UR  - http://dx.doi.org/10.1186/s13063-015-1112-4
UR  - http://hdl.handle.net/10044/1/28315
VL  - 16
ER  - 

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