Fibrinogen Early In Severe Trauma studY

- Haemorrhage in severe trauma is a significant cause of mortality and is potentially the most preventable cause of death in trauma patients - Trauma Induced Coagulopathy (TIC) is a complex coagulopathy associated with severe trauma - Hypo/dysfibrinogenaemia plays an important role in TIC - Early replacement of fibrinogen may improve outcomes - Fibrinogen replacement is potentially inadequate in standard fixed ratio Major Haemorrhage Protocols (MHP) utilising Plasma and/or Cryoprecipitate - The majority of centres utilise cryoprecipitate for additional fibrinogen supplementation as part of a MHP - Cryoprecipitate administration is often delayed (between 60 - 120 minutes) in a fixed ratio MHP - It is clear early intervention in severe traumatic haemorrhage is associated with improved outcomes - CRASH 2 and PROPPR studies - Increasing interest in the use of Fibrinogen Concentrate (FC) in severe bleeding but not supported by high level evidence - Benefits of FC - viral inactivation, known dose, easily reconstituted, can be administered quickly in high dose and stored at room temperature in the trauma resuscitation bay - No previous studies comparing FC and Cryoprecipitate in bleeding trauma patients - Fibrinogen supplementation will be guided by an accepted ROTEM targeted treatment algorithm - It will be a pilot, multi-centre randomised controlled trial comparing FC to Cryoprecipitate (current standard practise in fibrinogen supplementation) - Hypothesis: Fibrinogen replacement in severe traumatic haemorrhage can be achieved quicker with a more predictable dose response using Fibrinogen Concentrate compared to Cryoprecipitate - It is imperative that robust and clinically relevant trials are performed to investigate fibrinogen supplementation in trauma before widespread adoption makes performing such studies unfeasible