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. The TRansfusion and TReatment of severe Anaemia in African Children: (TRACT ISRCTN84086586) is a 3x2x2 factorial controlled trial involving 3954 children (aged 2m to 12y) with severe anaemia (haemoglobin <6g/dl). The trial has been designed to address the poor outcomes following SA in children in sub-Saharan Africa, which is associated with high rates of in-hospital mortality (9-10%), 6-month case fatality (12%) and relapse or re-hospitalisation (6%) indicating that the current recommendations and/or management strategies are not working in practice. Hospitalised children will be enrolled at 4 centres in 2 countries (Malawi, Uganda) and followed for 6 months. TRACT trial is designed to answer 4 simple questions. Q1 and 2: which children should receive a transfusion (since current guidelines recommend transfusions only in children with a Hb <4g/dl (or <6g/dl if accompanied by complications)); and how volume to transfuse in each transfusion event?. Q3 and 4: Since the major factors related to poor longer term outcome are micronutrient deficiencies and sepsis would post-discharge multi-vitamin multi-mineral supplementation versus routine care (folate and iron) for 3 months and/or cotrimoxazole prophylaxis for 3 months versus no prophylaxis improve outcome and prevent relapse. Primary outcome is cumulative mortality to 4 weeks for the transfusion strategy comparisons, and to 6 months for the nutritional support/antibiotic prophylaxis comparisons.
If confirmed by the trial, a cheap and widely available ‘bundle’ of effective interventions could lead to, if widely implemented, substantial reductions in mortality in African children hospitalised with severe anaemia every year. The trial started in Sept 2014 and currently 2700 children have been enrolled. We expect the trial results to be available in 2017.