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Table 3 Outcome measures

From: Transfusion and Treatment of severe anaemia in African children (TRACT): a study protocol for a randomised controlled trial

Primary outcome
 Cumulative mortality to 28 days for the transfusion strategy comparison, and to 180 days for the nutritional support/antibiotic prophylaxis comparison
Secondary outcomes
 Mortality: at 48 hours, 28 days, 90 days and 180 days (cumulative) where not the primary outcome
 Morbidity: endpoints relating to the specific mechanisms of action of each intervention:
  re-admission to hospital
  haematological:
  proportion achieving correction of anaemia (defined by the WHO as Hb > 9 g/dl) at 48 hours, 28 days, 90 days and 180 days
  development of new profound anaemia (Hb < 4 g/dl) during acute admission or development of severe anaemia (Hb < 6 g/dl) post discharge
  nutritional: changes in weight and mid-upper arm circumference (MUAC) at 90 days and 180 days
  anti-infection: changes in inflammatory markers (C-reactive protein (CRP) , procalcitonin), incidence of bacterial infections and malaria at 28 days, 90 days and 180 days
  solicited adverse events: suspected transfusion reactions: febrile reactions, TRALI (Transfusion Related Acute Lung Injury) (any grade); grade 3–4 toxicity of cotrimoxazole, MVMM or standard iron/folate
  serious adverse events
  costs and cost-effectiveness