Background: 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.
Materials and methods: 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.
Results: 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.
Discussion: 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.