Prospective multi‐centre haemovigilance of amotosalen and ultraviolet A ‐treated platelets and plasma in routine clinical use

Abstract Background and Objectives Amotosalen/ultraviolet A light (A/UVA) pathogen‐reduced platelets and plasma have been approved for clinical use in Europe since 2003 and 2006, respectively. Cross‐sectional safety haemovigilance (HV) studies have been conducted in 29 hospitals in 15 European countries since 2003. This report describes the most recent safety and utilization parameters for pathogen‐reduced platelets and plasma at three European hospitals between 2019 and 2025. Materials and Methods All consecutive patients who received at least one A/UVA platelet or plasma component at participating hospitals in Austria, Poland and Italy were enrolled in a prospective, non‐interventional HV study. Patient medical records were reviewed for transfusion reactions (TRs) within 24 h of each transfusion and for serious TRs within 7 days of transfusion. Descriptive per‐patient and per‐transfusion statistics were calculated for component use and safety variables at each site. Results A total of 516 adults received 5331 A/UVA components. Of these, 475 patients received 3424 platelet components (PCs), 87 patients received 1907 plasma components and 46 patients received both components. Most patients received prophylactic platelet transfusions for haematology‐oncology indications. Eight TRs were reported in seven recipients (six TRs in five platelet recipients; two TRs in two plasma recipients). All reactions were non‐serious and consisted mainly of febrile non‐haemolytic and allergic reactions; one instance of transfusion‐associated dyspnoea was reported after platelet transfusion. No transfusion‐related acute lung injury (TRALI), transfusion‐associated circulatory overload (TACO), transfusion‐transmitted infection, transfusion‐associated graft‐versus‐host disease (TA‐GVHD) or transfusion‐related deaths were observed. Conclusion A/UVA platelets and plasma were well tolerated in routine clinical use in three European centres with low TR rates and stable utilization.