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Collection of two units of leukoreduced RBCs from a single donation with a portable multiple-component collection
Edward L Snyder1, M Dean Elfath, Harry Taylor
1Department of Laboratory Medicine, Yale University, New Haven, Connecticut 06504, USA. edward.snyder@yale.edu
Background:
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.
Study Design And Methods:
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.
Results:
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.
Conclusions:
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.