The TRACT trial: no mortality benefit observed in African children with uncomplicated severe anemia who receive transfusion

1. In African children with uncomplicated severe anemia, immediate blood transfusion did not notably alter patient mortality at 1- or 6-months post treatment compared to patients treated under current practice.

2. Rates of hospital readmission, serious adverse events, and hemoglobin recovery were similar between the two groups.

Evidence Rating Level: 1 (Excellent)  

Study Rundown: Severe anemia, with hemoglobin <6 g/dl, is a leading cause of hospitalization in African children. Patients admitted for severe anemia have notable mortality rates. Due to resource limitations, transfusion for uncomplicated severe anemia is not advised if hemoglobin is between 4 and 6 g/dl. This randomized controlled trial evaluated patients who received immediate transfusion and those who did not, with no mortality difference observed between the two groups at 1 month or 6 months post randomization. Additionally, secondary outcomes of readmission, serious adverse events, and hemoglobin recovery at 6 months did not differ between the groups.

This study clinically evaluates patient outcomes observed for patients treated with notably different treatment thresholds, and secondarily evaluates resource utilization for context. Of note, hospital stay was longer for the control group and cost implications of monitoring are a consideration despite there being no observed mortality benefit to immediate transfusion.

Click to read the study in NEJM

Click to read an accompanying editorial in NEJM

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

In-Depth [randomized controlled trial]: This multicenter, factorial, randomized, controlled trial enrolled patients in Uganda and Malawi between 2014 and 2017. Eligible patients were between 2 months and 12 years of age and were hospitalized for uncomplicated severe anemia with a hemoglobin between 4 and 6 g/dl. Patients with known chronic diseases (including sickle cell disease) or who were admitted for an acute illness were excluded. Patients were randomly assigned in a 1:1 manner to undergo immediate transfusion (n=778) or no immediate transfusion (n=787), with transfused patients receiving 20 or 30 ml of whole blood per kilogram of body weight. Patients were monitored while in the hospital and at days 28, 90, and 180 post discharge for clinical outcomes and hemoglobin levels. The primary outcome of mortality at 28 days post-randomization occurred in 0.9% and 1.7% of patients in the treatment and controls groups, respectfully (hazard ratio, 0.54; 95% confidence interval [CI], 0.22 to 1.36; P=0.19). At day 180 mortality had occurred in 4.5% and 6.0% of treatment and control patients, respectfully (hazard ratio, 0.75; 95% CI, 0.48 to 1.15). By day 28 hemoglobin level was higher in the treatment group by an average of 0.6 g/dl, though by day 180 there was no significant difference in hemoglobin levels between groups. The median length of stay was 3 days in the treatment group and 4 days in the control group. The costs of treatment, including for hospital stay, transfusions, and blood tests, was $72.09 in the immediate-transfusion group and $66.46 in the control group. Over a period of 180 days, life-years gained was similar in the two groups.

Image: PD

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