CLINICAL EVALUATION OF A NOVEL MEMBRANE PLASMA SEPARATOR FOR DONOR PLASMAPHERESIS

For the purpose of making Donor Plasmapheresis (DP) more popular, a novel device (MS-201, TERUMO Corporation, Tokyo) for DP has been developed, which is composed of a membrane plasma separator, a blood and a plasma collection bag each and connected tubes. The module consists of 16 circular layers of the membrane made of polypropylene coated with hydrophilic polymers. This device requires no priming operation with saline. DP using this system was carried out on 31 healthy male donors. This device functioned well to collect plasma and was accepted favorably by the donors. None of the donors experienced adverse effects. Our study showed that the module had good biocompatibility since mean values of activation markers of complement (C3a and C5a), platelet (β-TG, PF-4) and coagulation (FPA) as well as hemolysis (free Hb, Hp, LDH) increased a little more than or within normal limits. The recovery and sieving coefficients of TP, Alb, AT-III, F-VIII and Fibrinogen were more than 0.95. It took a mean time of 33.7±6.2 minutes from needle punctures of vein to collecting 450ml of plasma including anticoagulant. In conclusion, this donor plasmapheresis system could be safely used and easily accepted to process in mobiles with a portable size.