Severe Anaemia Clinical Trial
Official title:
Phase II Trial of Transfusion Volumes in Children With Acute Severe Anaemia
Greater volume of whole blood(30mls/kg compared to 20mls/kg) following standard calculations, given to children with severe anaemia will be beneficial in haematological correction and can be given safely since respiratory distress and haemodynamic changes result from acidosis and compensation in these children rather than from biventricular failure.
Severe anemia (SA, hemoglobin <6 g/dl) is a leading cause of pediatric hospital admission in
Africa, with significant in-hospital mortality. The underlying etiology is often infectious,
but specific pathogens are rarely identified. Guidelines developed to encourage rational
blood use recommend a standard volume of whole blood (20 ml/kg) for transfusion, but this is
commonly associated with a frequent need for repeat transfusion and poor outcome. Evidence
is lacking on what haemoglobin threshold criteria for intervention and volume are associated
with the optimal survival outcomes.
We evaluated the safety and efficacy of a higher volume of whole blood (30 ml/kg; Tx30: n =
78) against the standard volume (20 ml/kg; Tx20: n = 82) in Ugandan children (median age
35.5 months (interquartile range (IQR) 12.5 to 52.5)) for 24-hour anemia correction
(hemoglobin >6 g/dl: primary outcome) and 28-day survival.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment