Fibrinogen Early In Severe Trauma studY
Condition: Trauma; Haemorrhage; Coagulopathy
MeSH terms: Hemorrhage
Study type: Interventional
Phase: Phase 2

Summary: 
      -  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
    


Intervention name(s): Fibrinogen Concentrate; Cryoprecipitate
Intervention type(s): Drug; Other
Intervention description(s): Fibrinogen Replacement using Fibrinogen Concentrate as per ROTEM guided treatment algorithm [FIBTEM ≤ A5 10mm]
FIBTEM A5 0mm (Flat Line) = 6g FC FIBTEM A5 1 - 4mm = 5g FC FIBTEM A5 5 - 6mm = 4g FC FIBTEM A5 7 - 8mm = 3g FC FIBTEM A5 9 - 10mm = 2g FC; Fibrinogen replacement using Cryoprecipitate as per ROTEM guided treatment algorithm [FIBTEM A5 ≤ 10mm]
FIBTEM A5 0mm (Flat Line) = 20 Units Cryo FIBTEM A5 1- 4mm = 16 Units Cryo FIBTEM A5 5 - 6mm = 14 Units Cryo FIBTEM A5 7 - 8mm = 10 Units Cryo FIBTEM A5 9 - 10mm = 8 Units Cryo
Other intervention name(s): RIASTAP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fibrinogen; Cryoprecipitate