In vitro and in vivo evaluation of a whole blood platelet‐sparing leukoreduction filtration system

Abstract

In-line leukoreduction (LR) filters decrease adverse clinical sequelae caused by residual white blood cells (WBCs). Such filtration, however, can remove platelets (PLTs) needed for production of PLT concentrates (PCs). This study measured in vitro and in vivo efficacy of a new whole blood PLT-sparing LR filter (WBPSF) system that performs whole blood (WB) LR using a single closed-system filtration step. The WBPSF provides three final LR products: AS-5 red blood cells (RBCs), citrate-phosphate-dextrose (CPD) PLTs, and CPD plasma. Volunteers (n=59) donated WB processed using the WBPSF system. WB filtration time was recorded, and LR WB was processed into AS-5 LR RBCs, CPD LR PLTs, and LR plasma. Final components were assayed for in vitro indices, and in vivo characteristics for LR AS-5 RBCs and CPD PLTs were assayed after radiolabeling. WB filtration time averaged 37 minutes. Transfusion products obtained after WBPSF met all in vitro and in vivo Food and Drug Administration (FDA) requirements. Radiolabeling of LR AS-5 RBCs after WBPSF showed a 24-hour RBC recovery of 81.3±5.3% after 42 days of storage. In vivo dual (111) In/(51) Cr radiolabeling of PCs manufactured using WBPSF showed a Day 5 recovery ratio of 80±19% versus fresh autologous PLTs and a survival ratio of 81±17% that of fresh autologous PLTs. All WBPSF-derived transfusion products met or exceeded in vitro and in vivo FDA guidelines. This filtration system is suitable for routine blood center or hospital use in the production of LR AS-5 RBCs, CPD PLTs, and CPD plasma.