International, prospective haemovigilance study on methylene blue‐treated plasma. Issue 4 (26th March 2017)

• Record Type: Journal Article
• Authors: Noens, L.; Vilariño, Ma. D.; Megalou, A.; Qureshi, H.
• Is Part Of: Vox sanguinis. Volume 112:Issue 4(2017)
• Page Start: 352
• Page End: 359
• Publication Date: 2017-03-26
• Subjects: blood safety -- haemovigilance -- methylene blue -- pathogen reduction; Blood -- Periodicals; Blood -- Transfusion -- Periodicals; Immunohematology -- Periodicals; Immunopathology -- Periodicals; 615.39
• DOI: 10.1111/vox.12510
• Languages: English
• ISSNs: 0042-9007

Abstract

Abstract : Background and objectives: 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. Materials and 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. Conclusion: Methylene blue plasma has a very acceptable safety profile with a rate of serious adverse reactions of 0·5/10 000 units.