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

Abstract

Objectives: Fast thawing for emergency situations and reduction of plasma wastage.

Background: Evaluation of plasma units, pooled and pathogen reduced (PR) in "maxi-pools" with amotosalen and UVA light, and fast thawing.

Methods/materials: 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).

Fviii: C, Fibrinogen, albumin, IgG, protein S and VWF were measured in plasma units, maxi-pools and plasmas after PR treatment and thawing.

Results: 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.

Conclusion: 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.