Pre-hospital Administration of Fibrinogen in Trauma-Induced Coagulopathy

A prospective, randomized controlled trial of fibrinogen concentrate (FC) plus standard of care versus standard of care alone in adult trauma patients with major bleeding or presumed major bleeding is developed to evaluate the efficacy and safety of prehospital administration of FC in trauma patients with suspected hypofibrinogenemia and active bleeding or presumed to be bleeding.

The main endpoints are:

1. Plasma fibrinogen levels in the first blood sample drawn at the patient's arrival at the trauma room and/or similar emergency bay dedicated to trauma and reanimation above the critical threshold of 2.0 g/l. As fibrinogen decreases early in trauma, its deficiency predicts massive bleeding and death. 2. Administration feasibility of FC within the prehospital setting.

Patients will be randomly assigned to receive either standard trauma care or standard trauma care plus administration of FC.