title: Hemovigilance survey of pathogen-reduced blood components in the Warsaw Region in the 2009 to 2013 period.
abstract: BACKGROUND
  In 2009 the Mirasol Pathogen Reduction Technology (PRT) was introduced to the routine blood component production of the Regional Blood Transfusion Center in Warsaw (RBTCW). The goal of this study was to investigate the safety of Mirasol-treated blood components.
  
  
  METHODS
  The accumulated passive hemovigilance data of Mirasol-treated blood components collected at the RBTCW are presented and compared to historical and contemporary data. Furthermore, active hemovigilance data collected from patients with different hematologic disorders transfused with Mirasol-treated or untreated blood components at the Institute of Hematology and Transfusion Medicine (IHTM) are presented and discussed.
  
  
  RESULTS
  The adverse reaction (AR) reporting rate by hospitals to the RBTCW after the implementation of the Mirasol technology was 0.39% for Mirasol-treated platelet concentrates (M-PCs) and 0.05% for Mirasol-treated fresh-frozen plasma. When comparing contemporary rates of ARs recorded by RBTCW in the time period 2011 to 2012, no statistical difference was observed between Mirasol-treated and untreated blood components. No serious AR was attributed to Mirasol-treated components. At the IHTM a lower rate of ARs after transfusion of M-PCs was observed than with untreated PCs. Despite the fact that very large amounts of Mirasol-treated plasma have been transfused to patients with congenital or acquired thrombotic thrombocytopenic purpura, no significant increase in AR rates was observed.
  
  
  CONCLUSIONS
  Treatment of blood components with the Mirasol PRT System has proven to be safe for patients and is not associated with increased rates and grades of adverse events in patients of hospitals in the Warsaw Region.
authors.affiliation: Institute of Hematology and Transfusion Medicine, Warsaw, Poland.
authors.forename: Magdalena
authors.initials: M
authors.lastname: Łętowska
authors.affiliation: Regional Blood Transfusion Center of Warsaw, Warsaw, Poland.
authors.forename: Zofia
authors.initials: Z
authors.lastname: Przybylska
authors.affiliation: Regional Blood Transfusion Center of Warsaw, Warsaw, Poland.
authors.forename: Dariusz
authors.initials: D
authors.lastname: Piotrowski
authors.affiliation: Institute of Hematology and Transfusion Medicine, Warsaw, Poland.
authors.forename: Elżbieta
authors.initials: E
authors.lastname: Lachert
authors.affiliation: Institute of Hematology and Transfusion Medicine, Warsaw, Poland.
authors.forename: Aleksandra
authors.initials: A
authors.lastname: Rosiek
authors.affiliation: Institute of Hematology and Transfusion Medicine, Warsaw, Poland.
authors.forename: Lech
authors.initials: L
authors.lastname: Rzymkiewicz
authors.affiliation: Terumo BCT, Zaventem, Belgium.
authors.forename: Marcia
authors.initials: M
authors.lastname: Cardoso
mesh_terms: D001792:Blood Platelets; D058731:Blood Safety / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D010949:Plasma; D017713:Platelet Transfusion / Q000009:adverse effects / Q000379:methods*; D011044:Poland; D011697:Purpura, Thrombotic Thrombocytopenic / Q000628:therapy*; D012189:Retrospective Studies