A MULTICENTER EVALUATION OF THE ROUTINE USE OF A NEW WHITE CELL-REDUCTION APHERESIS SYSTEM FOR COLLECTION OF PLATELETS

BACKGROUND: Residual white cells (WBCs) cause serious side effects in platelet transfusion. An in-line WBC-reduction system based on fluidiz ed particle bed technology was recently developed as a modification of an existing plateletpheresis system. STUDY DESIGN AND METHODS: In an investigational phase, three flow profiles were evaluated using protot ype software in five centers, each using their standard conditions. In the confirmatory phase, the released software was tested in three cen ters. WBCs were counted in two full Nageotte grids (dilution 1-in-5). RESULTS: With the prototype software, WBC levels were always below 1 x 10(6) per procedure (median, 25,000/procedure; n = 314). One profile proved to be superior to the other two with respect to platelet yield and residual WBCs, and it was incorporated in the released WBC-reducti on system, together with a built-in process control. Median residual W BCs in these WBC-reduction system components not rejected by the proce ss control were 19,000 per procedure (n = 211/225 total), with 99.5 pe rcent of the platelet components having less than 1 x 10(6) WBCs. CONC LUSION: The protocol selected in the initial phase, now available as a WBC-reduction system, results in platelet concentrates with very low residual WBC levels. This satisfies even the most stringent criteria f or WBC reduction in platelets, without the platelet loss typically see n with conventional fiber filtration.