Evolution of the use of Therapeutic Fibrinogen Concentrate in the Massive Bleeding Guidelines

Abstract

Fibrinogen concentrate was approved for the first time in the European Union by the German Federal Ministry of Health on January 4th, 1966. Since then, its use has been shown to be effective and well-tolerated in numerous clinical studies with congenital or acquired fibrinogen deficiency. In this review, we analyze the evolution of the indications for the use of fibrinogen concentrate in massive bleeding guidelines in three main clinical scenarios of acquired hypofibrinogenemia, such as cardiac, obstetric, and polytrauma patients.

In cardiac surgery, the administration of fibrinogen has become a noteworthy tool in the management of perioperative haemostasis. The implementation of therapeutic algorithms, together with the use of viscoelastic coagulation tests, has allowed a faster and more personalized diagnosis and treatment of perioperative bleeding. In obstetrics, fibrinogen administration has evolved significantly over the years to a part of the management of massive obstetric haemorrhage, with early administration of fibrinogen now considered important in cases of hypofibrinogenemia during haemorrhage, helping to effectively correct coagulopathy and improve maternal outcomes. Currently, the implementation of protocols based on point-of-care viscoelastic testing has proven to be useful in the management of obstetric haemorrhage. In polytrauma patients with severe bleeding, fibrinogen administration is recommended based on clinical criteria and prior to laboratory test outcomes. After this first approach, guidelines recommend goal-directed coagulation management based on the results of viscoelastic tests and, in their absence, classical laboratory tests are recommended.