Background: The World Health Organization recommends a haemoglobin transfusion threshold of <4g/dl for children with uncomplicated anaemia. High rates of mortality and re-admission in African children with severe anaemia suggest a less restrictive transfusion threshold might improve outcomes. Methods: The TRACT factorial open-label trial randomized Ugandan/Malawian children aged 2 months to 12 years with haemoglobin 4-6g/dl and no severity signs to immediate transfusion with 20-30mls/kg whole-blood equivalent or transfusion triggered by new severity signs or haemoglobin fall to <4g/dl. Three other randomizations investigated blood volume, post-discharge micronutrients and/or cotrimoxazole. The primary endpoint was 28-day mortality. Results: 1565 children (median 26 months; 977(62%) with malaria) were randomized to immediate (n=778) or triggered (n=787) transfusion and followed for 180-days (71(5%) lost-to-follow-up). 778(100%) immediate vs 386(49%) triggered children were transfused during admission, a median 1.2 vs 24.9 hours from randomization: receiving mean (standard deviation) 314(228) vs 142(224) mls total whole-blood equivalent respectively. 7(1%) immediate vs 13(2%) triggered children died before 28-days (hazard ratio[HR]=0.54 (95% CI 0.22-1.36) p=0.19), and 35(4%) vs 47(6%) respectively before 180-days (HR=0.75 (0.48-1.16) p=0.19), with no evidence of interaction with other randomizations (p>0.2) nor evidence of differences between groups in re-admissions (p=0.36), serious adverse events (p=0.36) nor in haemoglobin recovery at 180-days (p=0.08). Length-of-stay was mean 0.9 days longer in the triggered group. Conclusions: There was no evidence of differences in clinical outcomes over 6 months with triggered vs immediate transfusion. Triggered transfusion reduced blood-volume requirements by 60% but increased length-of-stay by 20% and required repeated haemoglobin monitoring and surveillance.
CORE (COnnecting REpositories)
CORE (COnnecting REpositories)