CLINICAL-TRIAL AND LOCAL-PROCESS EVALUATION OF AN APHERESIS SYSTEM FOR PREPARATION OF WHITE CELL-REDUCED PLATELET COMPONENTS

BACKGROUND: A new method for the consistent preparation of white cell (WBC)-reduced plateletpheresis components, the Spectra Leukoreduction System (LRS), was evaluated by clinical trial and local process valida tion. The centrifuge-based system was projected to decrease the WBC co ntent of plateletpheresis components to a level below 1 x 10(6) per un it. Phase I and II clinical trials were performed. The manufacturer's claims were then tested at the local level with an ongoing quality ass urance program. STUDY DESIGN AND METHODS: In Phase I, a crossover anal ysis of five subjects compared LRS to standard plateletpheresis proced ures in collection efficiency and component quality: a panel of in vit ro measures was taken on Day 0 and Day 5. In Phase II, the LRS process was tested on a larger scale (n = 57; control = 58) with component tr ansfusion. Finally, validation, determination of degree of conformance with standards, and ongoing quality control were performed locally on a newly installed instrument. RESULTS: Phase I and II trials revealed no significant differences between LRS and control units in donor or recipient safety and comfort, platelet function and yield, or componen t volume. WBC per-unit values were significantly different: the LRS me dian per unit was 3.2 x 10(4) WBCs, versus 81.4 x 10(4) for control un its. Assessment of process capability gave an estimate of gs-percent c onfidence that 99.5 percent of LRS units would be WBC reduced to <1 x 10(6) WBCs. Local process validation and quality control revealed 90-p ercent confidence that 99 percent of the units would be WBC reduced an d 99.9-percent confidence that 75 percent would exceed platelet yield standards; the process was stable over time. CONCLUSIONS: The LRS is s afe for apheresis and the component produced is safe for transfusion w ith platelet function and yield equivalent to controls and WBC reducti on superior to controls. Local process evaluation confirmed that compo nent quality meets the goals of the institution.