Fibrinogen is a plasmatic coagulation protein produced in the liver and is not only essential, but is also one of the most important factors of the clotting cascade. Upon conversion into fibrin, it takes on a crucial role in clot formation and haemostasis. In case of fibrinogen deficiency, the blood’s ability to form a clot is impaired, leading to a greatly increased risk of critical bleeding and additionally to a delay in bleeding cessation.
In the case of severe congenital fibrinogen deficiency, patients' ability to produce sufficient levels of functional fibrinogen is impaired or absent. These patients require frequent injections of fibrinogen concentrate. In acquired fibrinogen deficiency, patients lose endogenous fibrinogen, which can lead to uncontrolled bleeding. A frequent cause is high blood loss during complex surgery but also severe traumatic injuries. In this case fibrinogen must be administered intravenously to stop the bleeding by increasing fibrinogen above the critical level.
Biotest's fibrinogen concentrate has been investigated clinically in a multinational phase I/III trial in patients with congenital fibrinogen deficiency. The trial data are currently being evaluated. For the acquired fibrinogen deficiency Biotest is conducting a Phase III study (AdFirst: Adjusted Fibrinogen Replacement Strategy) in several European countries in patients with high blood loss during spine surgery or abdominal surgery for treatment of pseudomyxoma peritonei (PMP).