Liberal versus restrictive red blood cell transfusion thresholds in hematopoietic cell transplantation: a randomized, open label, phase III, noninferiority trial.
This trial is a non-inferiority RCT comparing the effect of a liberal versus restrictive transfusion strategy on health-related quality of life (HRQOL) in patients undergoing haematopoietic stem cell (HCT) transplant. The study focuses on HRQOL since multiple transfusion trials have already examined and shown no difference between a liberal versus restrictive transfusion strategy on mortality and morbidity as outcomes. Patients undergoing HCT are an interesting population to study given the prolonged periods of anaemia and are generally chronically transfusion dependent.
The study randomised 299 participants (150 liberal strategy group, 149 in the restrictive strategy group). The primary outcome was HRQOL measured by the FACT-BMT instrument at 100 days after HCT. HRQOL was also measured at 7, 14, 28, and 100 days after HCT. At day 100 there was no difference in HRQOL between the restrictive versus the liberal group. At day 7, 14, and 28 patients in the restrictive group had higher rated HRQOL, but the scores were not deemed to be statistically significant compared to the liberal strategy group.
These results are important because they shed light on the effects of a liberal versus restrictive transfusion strategy on HRQOL in an important and understudied patient population. The results add data to further support the use of restrictive transfusion practices.
– Micah T. Prochaska (SABM reviewer)