Wed, 8 March 2017
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.