Fibrinogen Early In Severe Trauma studY

Overview

* 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