Cord blood red cell concentrates for preterm neonate transfusion: Insights from the multicenter BORN trial

Background: The BORN trial suggested that using cord blood-red blood cells (CB-RBCs) to transfuse severely preterm neonates significantly improves clinical outcomes compared to standard adult donor RBCs (A-RBC). Study Design and Methods: The study illustrates CB-RBC concentrate production and inventory management across nine CB banks participating in the BORN trial. Quality requirements were those established by the European regulation for leukocyte-depleted RBC concentrates in additive solution. The compliance rate among centers was reported. Results: During the BORN study, 451 CB-RBC units were processed and 107 were transfused to 69 patients in the intervention arm. However, for 67 transfusion requests, no compatible CB-RBC units were available and adult-RBCs were given. The CB-RBC inventory comprised a minor fraction of CB units collected during the study period, suggesting that many did not meet the protocol-defined volume threshold of 67 mL at collection. Quality control results showed that 84.0% of units achieved target hematocrit (Htc) levels (50–70%), with higher success rates in centers processing more CB units. All centers met quality standards, maintaining residual leukocytes below 1 × 106 and end-storage hemolysis below 0.8% in more than 90% of cases. CB-RBC availability was significantly limited by the time required for bacterial testing results and the need for γ-irradiation. Discussion: These data suggest that the standardized CB-RBC production is reproducible. Moreover, extending CB-RBC storage to 21 days could maximize the inventory utility.