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

Abstract

The Clottafact safety profile observed during the study matched the known profile of fibrinogen during use.

Golden hour for fibrinogen concentrate infusion to improve post partum hemorrhage

“…Even if our results (bleeding and transfusion) are in favor of early fibrinogen administration and aggressive therapeutic strategy, the safety of this strategy should be discussed [4]. Moreover, the risk of thromboembolic events associated with the use of fibrinogen concentrate has never been explored in this context (PPH).…”

The role of fibrinogen and fibrinogen concentrate in cardiac surgery: an international consensus statement from the Haemostasis and Transfusion Scientific Subcommittee of the European Association of Cardiothoracic Anaesthesiology

“…In the subsequent logistic regression analysis, the use of fibrinogen concentrate was not associated with an increase in mortality or thromboembolic events. In a post‐authorisation safety study, Clottafact ® (LFB Biomedicaments, France), a human plasma‐derived fibrinogen concentrate was evaluated . Amongst 156 total patients, two from the same centre experienced a thromboembolic event (pulmonary embolism/four‐site venous thromboembolic episode).…”

Blood, blood components, plasma, and plasma products

“…A recent clinical trial of temperature cycling during platelet cold storage showed improvement in vivo recovery and survival in healthy volunteers. Temperature cycling platelets had in vivo recovery of 42 In an observational study of platelet transfusion reactions in the Netherlands, a total of 2407 transfusion reactions were reported during 2006-2015. Platelet concentrates stored in plasma (plasma-PLT) were compared to platelet concentrate stored in platelet additive solution (PAS) from two different manufacturers (PAS-B-PLT, PAS-C-PLT).…”