Front Med (Lausanne)
May 2022
Background And Objective: The use of fibrinogen concentrate to treat or prevent major bleeding with regard to potential adverse reactions has not been free of controversy. Our objective was to perform a post-authorization safety study to describe the use of Clottafact (LFB Biomedicaments) fibrinogen concentrate in real-life medical practice in Mexico.
Methods: This was a prospective, observational study that collected and evaluated information between January 2017 and June 2019 related to suspected serious adverse reactions (SUSARs) during and after Clottafact infusion.