Universal Pathogen-Reduced Plasma in Elective Open-Heart Surgery and Liver Resection

Abstract

ABO-incompatible transfusions and transfusion-related lung injury are today the leading transfusion-related causes of death in the developed world. Since anti-A and anti-B antibodies in plasma can give rise to serious, even fatal, transfusion reactions,ABO-identical/compatible plasma is indicated, but presents a logistical challenge and a risk for transfusion of incorrect plasma. In an effort to circumvent these problems, an ABO-independent universally applicable, pathogen-reduced plasma, Uniplas, has been developed and proven safe and efficacious for use in adults through prospective, randomized, controlled open-heart surgery studies and in prospective, parallel group, controlled liver resection studies.The results of these trials are presented and discussed in relation to solvent/detergent (SD) treated plasma, in general.The cost effectiveness of pathogen-reduced plasma is low because of the very low risk for transfusion transmitted viral infections in the developed world (US $2 to $9 million per quality-adjusted life year). However, taking into account the combined safety of Uniplas with regard to transfusion-related lung injury, pathogen reduction and independence of ABO blood groups, the cost per gained life year is reduced to US $40,000 to $100,000.

Anti‐A and anti‐B titers in pooled group O platelets are comparable to apheresis platelets

“…25,28 Modern "pooled" universal plasma formulations (Uniplas, Octapharma Pharmazeutika, Austria; Bioplasma FDP, National Bioproducts Institute, Pinetown, South Africa) exist and contain a defined mixture of group A, B, AB, and O donor plasma with isohemagglutinin titers of less than 8 to less than 32 and acceptable transfusion safety. [29][30][31] Although extremely limited, our data suggest that mixed PPLTs, containing one WBD-PLT unit of recipient ABO type, could provide an additional layer of safety when out-of-group transfusion is unavoidable.…”

Pathogen reduced plasma products: a clinical practice scientific review from the AABB

“…Synopsis: Fifteen observational trials and seven RCTs were used to evaluate the safety of S/D plasma. No study reported an increase in AE in S/D plasma compared to conventional plasma and most reported a decrease.…”

Pathogen inactivation: an American view

“…PI has been used extensively in the manufacture of plasma protein fractions, and has all but eliminated transmission of infectious agents by these products [1]. In Europe, solvent‐detergent and methylene blue treatment have both been applied to plasma components, and psoralen treatment of platelets is being introduced in several countries [2–4]. Although solvent‐detergent‐treated pooled plasma has been approved for use in the USA and Canada, none of these methods has been adopted for single‐donor products in North America.…”