6/30/23, 2:19 AM TRACT Pathway Feedback Search Clinical Topics Home Studies TRACT TRACT Disease Iron deficiency anemia Trial question What is the role of immediate transfusion in children with uncomplicated severe anemia? Study design Multi-center Open label RCT Population Characteristics of study participants 44.0% female N = 1565 56.0% male 1565 patients (683 female, 882 male) Inclusion criteria: children 2 months to 12 years of age with uncomplicated severe anemia Key exclusion criteria: known chronic disease including kidney or liver failure, malignant conditions, or congenital heart disease; burns; trauma; surgery; previous transfusions during the same hospitalization; or exclusively breastfed children Interventions N=778 immediate transfusion (20 mL or 30 mL of whole-blood equivalent per kilogram of body weight) N=787 control (no immediate transfusion; transfusion with 20 mL of whole-blood equivalent per kilogram triggered by new signs of clinical severity or a drop in Hgb to < 4 g/dL) https://web.pathway.md/studies/recupSZUYCwjqjdD9 1/2 6/30/23, 2:19 AM TRACT Pathway Primary outcome Rate of death by day 28 1.7 % 1.7 1.3 % 0.9 0.8 % 0.4 % No significant difference 0.0 % Immediate transfusion Control No significant difference in the rate of death by day 28 (0.9% vs. 1.7%; HR 0.54, 95% CI 0.22 to 1.36) Secondary outcomes Borderline significant increase in length of hospital stay (3 days vs. 4 days; HR 1.62, 95% CI 1.46 to 1.8) No significant difference in readmission to hospital at 180 days (15.8% vs. 14.4%; HR 1.09, 95% CI 0.84 to 1.4) Borderline significant decrease in development of severe anemia after discharge (13.6% vs. 18%; HR 0.73, 95% CI 0.56 to 0.94) Safety outcomes No significant difference in serious adverse events. Significant differences in development of new profound anemia during primary hospitalization (1.4% vs. 39.3%), correction of anemia (51.3% vs. 5.5%). Conclusion In children 2 months to 12 years of age with uncomplicated severe anemia, immediate transfusion was not superior to control with respect to the rate of death by day 28. Reference Kathryn Maitland, Sarah Kiguli, Peter Olupot-Olupot et al. Immediate Transfusion in African Children with Uncomplicated Severe Anemia. N Engl J Med. 2019 Aug 1;381(5):407-419. Open reference URL https://web.pathway.md/studies/recupSZUYCwjqjdD9 2/2