title: International, prospective haemovigilance study on methylene blue-treated plasma.
abstract: OBJECTIVE
  Methylene blue is a phenothiazine dye, which in combination with visible light has virucidal and bactericidal properties, disrupting the replication of a broad range of enveloped viruses and some non-enveloped viruses. The study objective was to collect data on adverse reactions occurring with methylene blue plasma administered in a routine clinical practice environment and document their characteristics and severity.
  
  
  METHODS
  This was an open label, multicentre, non-controlled, non-randomized, non-interventional study. Patients who receive a methylene blue plasma transfusion were observed for any signs and symptoms (adverse reactions) within 24 h safter the start of the transfusion, in different hospitals for a study duration of at least 1 year.
  
  
  RESULTS
  A total of 19 315 methylene blue plasma units were transfused. There were eight patients with adverse reactions recorded during the study, one of them serious. Two had more than one reaction (two and four, respectively). Three patients had previous transfusions with methylene blue plasma only.
  
  
  CONCLUSIONS
  Methylene blue plasma has a very acceptable safety profile with a rate of serious adverse reactions of 0·5/10 000 units.
authors.affiliation: Universitair Ziekenhuis, Gent, Belgium.
authors.forename: L
authors.initials: L
authors.lastname: Noens
authors.affiliation: Complejo Universitario de Santiago de Compostela, Santiago de Compostela, Spain.
authors.forename: Ma D
authors.initials: MD
authors.lastname: Vilariño
authors.affiliation: Evaggelismos General Hospital of Athens, Athens, Greece.
authors.forename: A
authors.initials: A
authors.lastname: Megalou
authors.affiliation: University Hospitals of Leicester NHS Trust, Leicester, UK.
authors.forename: H
authors.initials: H
authors.lastname: Qureshi
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000890:Anti-Infective Agents / Q000008:administration & dosage*; D016913:Blood Component Transfusion / Q000009:adverse effects*; D058731:Blood Safety; D002648:Child; D005260:Female; D006801:Humans; D008027:Light; D008297:Male; D008751:Methylene Blue / Q000009:adverse effects*; D008875:Middle Aged; D010949:Plasma / Q000382:microbiology* / Q000821:virology; D011446:Prospective Studies; D055815:Young Adult
chemical_list: D000890:Anti-Infective Agents; D008751:Methylene Blue
keywords: blood safety; haemovigilance; methylene blue; pathogen reduction