Validation of pathogen reduced plasmas from maxi-pools combined with fast thawing.

Abstract

Fast thawing for emergency situations and reduction of plasma wastage. Evaluation of plasma units, pooled and pathogen reduced (PR) in "maxi-pools" with amotosalen and UVA light, and fast thawing. Per replicate, 10 WB-derived leukocyte depleted plasma units were frozen within 24 h at ≤ -25°C and stored for 7 days. After thawing, a maxi-pool was constituted from the 10 units. After splitting into 4 sub-pools of 650 mL, the sub-pools were PR treated then split into 3 units resulting in 12 PR plasma units at 200 mL. Hundred and twenty PR plasma units were produced in total. The units were frozen at ≤ -25°C for 1 week, then thawed either in a fast plasma thawer for 5 min or in other control devices (17 to 23 min). C, Fibrinogen, albumin, IgG, protein S and VWF were measured in plasma units, maxi-pools and plasmas after PR treatment and thawing. There was a statistically significant (p < 0.001) but still clinically acceptable (over the recommended levels of ≥0.5 IU/mL and ≥2 g/L) reduction of FVIII:C and Fibrinogen after PR with 69% and 87% recovery, respectively. Other proteins were not significantly affected by the processes. Pooling 10 plasma units before the PR treatment standardises volume and protein content of plasma units. Besides the economic value of generating 12 products for transfusion, this procedure combined with a thawing time of about 5 min is of value in emergency situations and may reduce plasma wastage.