Pilot study of ABO-isogroup or universal plasma pools with or without pathogen reduction treatment

In France, a standardized procedure has been introduced in which 5 units of plasma derived from whole blood are pooled into two equal volumes for pathogen reduction treatment (PRT). This method produces 6 fresh frozen plasmas treated with Amotosalen and Ultraviolet A (UVA) (FFP-A/UVA) from 5 native plasmas, reducing treatment time and disposable set costs, standardizing products, and decreasing adverse events by diluting allergens, cytokines, and antibodies.

This study aimed i) to compare concentrations of Factor VIII, fibrinogen, and soluble inflammatory factors in ABO-isogroup or universal plasma pools with or without A/UVA PRT, and ii) to evaluate the profile and standardization of plasma units in mini-pools (5 units) and maxi-pools (10 units). We analyzed three types of parameters: soluble inflammatory biomarkers (sCD40L, IFN-alpha, IFN-beta, IFN-gamma, IL-1 beta, IL-6, IL-8, IL-10, IL-18, TNF-alpha), fibrinogen and Factor VIII, and circulating immune complexes. The pilot study used samples from untreated and PRT-treated apheresis plasma units.

Factor VIII levels remained stable while fibrinogen levels significantly decreased in PRT-plasma, though still above 2 g/L. sCD40L significantly increased in individual PRT-treated plasma, while IL-18 levels were unchanged. Our results highlight the impact of the blood group distribution in the plasma mini and max pools on the concentrations of factor VIII and IL-18, but not on fibrinogen and sCD40L. We observed no circulating immune complexes and strong inter-individual variations in inflammatory molecules and significant reduction in variation in ABO-isogroup or universal plasma pools.

This study suggests to use the mini-pool approach to produce universal plasma or expanding it to larger volume mixtures. Blood group distribution is crucial, as sCD40L and IL-18 influence immune responses, potentially reducing allergic reactions post-transfusion with PRT-treated plasma. Further research, including post-transfusion follow-up, is necessary to explore the clinical relevance of these findings.