Postauthorization safety study of Clottafact® , a triply secured fibrinogen concentrate in acquired fibrinogen deficiency: a prospective observational study.

Background and Objectives A postauthorization safety study was performed between 2009 and 2012 to describe the use of Clottafact((R)) in acquired fibrinogen deficiency in real-life medical practice in France. Materials and Methods One hundred and fifty patients were planned for 28days of prospective follow-up after infusion. The analysis of this observational study was descriptive and performed according to the type of treatment (curative or preventive) and the origin of the bleed. Results One hundred and fifty-six patients (16-87years) were included in 13 centres and treated in five different medical bleeding situations: postpartum (59), other gynaecological/obstetrical (6), trauma (34), liver (13), cardiovascular (23) and other various bleeding situations (21). The mean follow-up time was 18.9 +/- 12.3days. Two patients presented adverse drug reactions: one a pulmonary embolism and the other a four-site venous thromboembolic episode. All were serious with a dubious causal relationship with the study treatment. Efficacy data were collected as a secondary objective. In 150 patients receiving curative treatment, 117 of 159 infusions (73.6%) were considered as successful by the investigators, 35 as moderate (22%) and seven as no response (4.4%). Conclusion The Clottafact((R)) safety profile observed during the study matched the known profile of fibrinogen during use.