International, prospective haemovigilance study on methylene blue-treated plasma

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.