Quality and safety of fresh‐frozen plasma inactivated and leucoreduced with the Theraflex methylene blue system including the Blueflex filter: 5 years’ experience

Abstract
Background and Objectives The objective of this paper is to present 5 years’ experience of pathogen inactivation of fresh‐frozen plasma with the methylene blue system in a blood centre in Athens. Materials and Methods Eight thousand and five hundred units treated by methylene blue and 54 435 untreated were issued for transfusion in four hospitals during the period 2000–2005. Eighty‐eight units were evaluated for changes in coagulation factor activity and cytokine concentrations following treatment. Results Coagulation factor losses were in the accepted range. Adverse reactions were 1 : 8500 with treated and 1 : 2177 with untreated units. The five serious reactions were all in untreated units. No seroconversions for infectious diseases were reported. Conclusions Methylene‐blue‐treated fresh‐frozen plasma is safer than the untreated product even in patients who require large quantities of plasma transfusion.