Trauma Clinical Trial
Official title:
Fibrinogen Concentrate vs Cryoprecipitate in Traumatic Haemorrhage: A Pilot Randomised Controlled Trial
- 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
n/a
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