Post-authorization safety study of Clottafact((R)), a triply secured fibrinogen concentrate in congenital afibrinogenemia. A prospective observational study

摘要

Background and ObjectivesA new fibrinogen concentrate Clottafact((R)) was developed according to European guidelines on plasma-derived products. A post-authorization safety study was set up in 2009 as part of the risk management plan. This was a non-interventional, prospective, non-comparative, multicenter study of the use of fibrinogen concentrate for congenital afibrinogenemia in real-life medical practice in France.