Collection of two units of leukoreduced RBCs from a single donation with a portable multiple-component collection system.

Abstract

A portable automated component collection system that produces double (2) units of leukoreduced RBCs (DRBCs) from a single donation was evaluated. This study analyzed quality of the collected and final products, the efficacy of automated leukoreduction, and donor safety. The system was used to collect 120 DRBCs. WBCs were removed from 90 products with machine-controlled filtration. DRBCs were collected in ACD-A and stored in AS-1 for 42 days at 1 to 6 degrees C. Pre- and postprocedure donor vital signs and hematologic parameters were measured. Procedure time, product characteristics, and adverse events were also recorded. In vitro studies were performed on all products on Day 0 and at end of storage. In vivo recoveries of 28 leukoreduced and 9 nonleukoreduced products were measured on Day 42. Day 0 mean percentage of hemolysis for leukoreduced and nonleukoreduced units was 0.05 percent. DRBCs had residual WBC counts of less than 1 x 106 cells per unit and mean RBC recovery after filtration of 91.9 +/- 2.7 percent. Mean 24-hour recovery after infusion for leukoreduced units at end of storage was 80.9 +/- 6.9 percent and nonleukoreduced units was 77.6 +/- 5.8 percent (p> 0.05). No clinically significant changes in donor vital signs or serious adverse events were observed. The quality of leukoreduced RBCs collected with this portable automated component collection system met or exceeded FDA requirements. This automated system is safe and effective for collection and processing of 2 units of RBCs suitable for transfusion.