Plateletapheresis with a next generation blood cell separator.

Procedure time has been identified as the most important element in apheresis platelet donor retention. Fenwal has developed a next generation apheresis system, the Amicus, with the intent of efficiently producing high platelet yields with low WBC content in much shorter processing times than currently available. This report describes the Amicus and presents results of a clinical trial of an Amicus prototype and a comparison to Fenwal CS 3000+. Thirty Amicus double-needle plateletapheresis procedures were evaluated. Average processing time was 61 ± 16 min with 63% of the processing times ≤ 60 min. The average preplatelet count was 246 ± 46 x 10 3 /μl, platelet yield 4.4 ± 1.2 x 10 11 plt, collection efficiency 73 ± 14%, platelet collection rate 0.075 ± 0.016 plt x 10 11 /ruin 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) processing times (64 ± 17 vs. 86 ± 10 min) and higher (P <.05) platelet 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 Amicus 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 collection 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 WBC 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 provide equivalent quantities of platelets with less WBC content in significantly shorter processing times than CS3000+ as well as shown encouraging results for single-needle procedures.