Mar 7, 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.
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.