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International, prospective haemovigilance study on methylene blue-treated plasma
L Noens1, Ma D Vilariño2, A Megalou3
1Universitair Ziekenhuis, Gent, Belgium.
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.
Insights
Methylene blue plasma transfusions demonstrate a strong safety profile, with serious adverse reactions occurring at a low rate of 0.5 per 10,000 units. This study monitored adverse events in routine clinical practice.
Area of Science:
- Biochemistry
- Microbiology
- Hematology
Background:
- Methylene blue is a phenothiazine dye with known virucidal and bactericidal properties.
- It disrupts viral replication for both enveloped and non-enveloped viruses.
- Its application in plasma transfusions warrants safety evaluation.
Purpose of the Study:
- To assess adverse reactions associated with methylene blue plasma.
- To document the characteristics and severity of these reactions.
- To evaluate safety in a routine clinical setting.
Main Methods:
- An open-label, multicenter, non-interventional study.
- Observation of patients receiving methylene blue plasma transfusions.
- Monitoring for adverse reactions within 24 hours post-transfusion over at least one year.
Main Results:
- 19,315 methylene blue plasma units were transfused.
- Eight patients experienced adverse reactions, with one serious event.
- Two patients had multiple adverse reactions.
Conclusions:
- Methylene blue plasma exhibits a highly acceptable safety profile.
- The rate of serious adverse reactions is very low (0.5/10,000 units).
- Supports the safe use of methylene blue plasma in clinical practice.
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