P28 Storage Study Of Red Blood Cells Treated With The Macopharma P‐CAPT™ Prion Removal Filter.

Abstract

Background Three occurrences of probable blood transfusion transmitted cases of vCJD have recently been reported in the UK. The P‐CAPTTM Prion Removal Filter (MacoPharma) has been developed to remove infectious prions potentially present in leucodepleted red blood cell concentrates (RBCC's). In order to be accepted for use in routine blood processing practice, the filter must retain the quality of RBCC's following treatment, in addition to conforming to blood service operational evaluation and manufacturing specifications.Aims The aim of this study was to investigate if filtration through the P‐CAPT™ filter has any deleterious effect on the quality of RBCC's stored in SAG‐M or plasma‐CPD.Methods RBCC's issued from leucodepleted Whole Blood (WB), either prepared in SAG‐M or plasma, were treated with the P‐CAPT™ filter at 20°C on day 0 or day 1 following a 4° storage after blood collection. To ensure comparative trials, a series of 3 WB units were pooled, mixed and then split into 3 equal units before being treated at either day 0 or at day 1. For each pool, one unit was not filtered through the P‐CAPT filter to serve as a reference. RBC Plasma‐CPD units (12) were stored upto 28 days and RBC SAG‐M units (18) were stored upto 42 days at +2°C/+6°C. Stability of the red cell concentrates was evaluated every 7 days by measuring hemolysis, pH, K+, pO2, pCO2, ATP, 2,3 DPG, glucose, lactate, and other parameters according to standard protocols.Results All the final product specifications (Hb g/unit, hematocrit, residual leucocytes, total volume) as well as end of shelf life product parameters (Hemolysis, ATP, 2,3 DPG, K+, pH) were within the routine specifications acceptable to the UK blood services (Guidelines for the Blood Transfusion Services in the UK “Red Book”) and met the Council of Europe Guidelines (Guide to the preparation, use and quality assurance of blood components). These results indicate that red blood cell stability is not adversely affected by exposure to the P‐CAPT™ filter, whether they are treated in SAG‐M solution at day 0 or day 1 or treated in plasma‐CPD at day 1.