PLATELETAPHERESIS WITH A NEXT-GENERATION BLOOD-CELL SEPARATOR

Procedure time has been identified as the most important element in ap heresis platelet donor retention. Fenwal has developed a next generati on apheresis system, the Amicus, with the intent of efficiently produc ing high platelet yields with low WBC content in much shorter processi ng times than currently available. This report describes the Amicus an d presents results of a clinical trial of an Amicus prototype and a co mparison to Fenwal CS 3000+. Thirty Amicus double-needle plateletapher esis procedures were evaluated. Average processing time was 61 +/- 16 min with 63% of the processing times less than or equal to 60 min. The average preplatelet count was 246 +/- 46 x 10(3)/mu l, platelet yield 4.4 +/- 1.2 x 10(11) plt, collection efficiency 73 +/- 14%, platelet collection rate 0.075 +/- 10.016 plt x 10(11)/min and citrate toxicity incidence 3%. A comparison of double needle procedures, 20 Amicus and 20 CS 3000+, showed that Amicus had significantly shorter (P <.05) pr ocessing times (64 +/- 17 vs. 86 +/- 10 min) and higher (P <.05) plate let collection rates (0.070 +/- 0.017 vs. 0.054 +/- 0.018 plt x 10(11) /min) but comparable (P <.05) platelet yields (4.4 +/- 1.4 vs. 4.7 +/- 1.0 x 10(11) plt). Comparison of 13 single and 13 double-needle Amicu s procedures showed comparable (P <.05) processing times (71 +/- 13 vs . 65 +/- 18 min), platelet yields (4.7 +/- 1.0 vs. 4.6 +/- 1.5 x 10(11 ) plt), collection efficiency (74 +/- 7 vs 74 +/- 17%), and platelet c ollection rates (0.068 +/- 0.020 vs 0.072 +/- 0.018 plt x 10(11)/min). Using normal probability plots of WBC content at 95% confidence level , Amicus can provide products with <5.0 x 10(6) WBC or <1.0 x 10(6) WB C in 99.7% or 92.7% of collections, respectively, compared with 69.0% or 44.0%, respectively, for CS 3000+. We found Amicus was able to prov ide equivalent quantities of platelets with less WBC content in signif icantly shorter processing times than CS3000+ as well as shown encoura ging results for single-needle procedures. (C) 1997 Wiley-Liss, Inc.