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Record number:
1185
Adverse Occurrence type:
MPHO Type:
Estimated frequency:
The incidence of adverse events was higher with Quarantine-FFP (1:3620) than methylene blue-FFP (1 : 24 593) by a factor of 6·79 [95% confidence interval (CI) 2·52–27·8]. Allergic adverse events were also commoner with Quarantine-FFP (1 : 7489) than with MB-FFP (1:24 593), by a factor of 3·28 (95% CI 1·17–13·7). All adverse reactions experienced by the MB plasma recipients were considered to be mild. Allergic reactions per 10,000 units: 0.41 and 1.34 for MB-FFP and Q-FFP respectively in Greece. In Catalonia, severe reactions to plasma always below 1 per 4700 units transfused.
Alerting signals, symptoms, evidence of occurrence:
Greek Hemovigilance definitions. Catalonia, Spain hemovigilance definitions
Demonstration of imputability or root cause:
Greek active hemovigilance program and Catalonia, Spain hemovigilance program
Imputability grade:
2 Probable
Groups audience:
Keywords:
References:
Suggest new keywords:
pathogen-reduced plasma
FFP (fresh frozen plasma)
Reference attachment:
Suggest references:
Munoz-Diaz, E. and Puig Lluis (2014). Allergic and anaphylactic reactions to methylene-blue-treated plasma in Catalonia in the period 2008-2013, Blood Transfu 12:628-630; Politis, C., Kavallierou, L., Hantziara, S., Parara, M., Zervou, E., Katsarou, O., Hatzitaki, M., Fountouli, P., Gioka, A., Tzioura, K., Koumarianos, S., Asariotou, M. and Richardson, C. (2014). Haemovigilance data on the use of methylene blue virally inactivated fresh frozen plasma with the Theraflex MB-Plasma System in comparison to quarantine plasma: 11 years' experience. Transf Med 24(5): 316-20. DOI 10.1111/tme.12144