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

Vox Sang. 2007 May;92(4):319-26. doi: 10.1111/j.1423-0410.2007.00898.x.

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.

MeSH terms

  • Anti-Infective Agents
  • Blood Coagulation Factors / metabolism
  • Cytokines / blood
  • Filtration
  • Greece
  • Humans
  • In Vitro Techniques
  • Leukocyte Reduction Procedures
  • Methylene Blue
  • Plasma Exchange / adverse effects
  • Plasma* / immunology
  • Plasma* / microbiology
  • Plasma* / physiology
  • Plasma* / virology
  • Quality Control
  • Safety
  • Transfusion Reaction

Substances

  • Anti-Infective Agents
  • Blood Coagulation Factors
  • Cytokines
  • Methylene Blue