1. Haemorrhage in severe trauma is a significant cause of mortality and is potentially the
most preventable cause of death in paediatric trauma patients
2. Trauma Induced Coagulopathy (TIC) is a complex coagulopathy associated with severe
trauma
3. Hypo/dysfibrinogenaemia plays an important role in TIC
4. Early replacement of fibrinogen may improve outcomes
5. Fibrinogen replacement is potentially inadequate in standard fixed ratio Major
Haemorrhage Protocols (MHP) utilising Plasma and/or Cryoprecipitate
6. The majority of centres utilise cryoprecipitate for additional fibrinogen
supplementation as part of a MHP
7. Cryoprecipitate administration is often delayed (between 60 - 120 minutes) in a fixed
ratio MHP
8. It is clear early intervention in severe traumatic haemorrhage is associated with
improved outcomes - CRASH 2 and PROPPR studies
9. Increasing interest in the use of Fibrinogen Concentrate (FC) in severe bleeding but not
supported by high level evidence
10. 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
12. No previous studies comparing FC and Cryoprecipitate in bleeding paediatric trauma
patients 13. Fibrinogen supplementation will be guided by an accepted ROTEM targeted
treatment algorithm 14. Pilot, multi-centre randomised controlled trial comparing FC to
Cryoprecipitate (current standard practise in fibrinogen supplementation) 15. Hypothesis:
Fibrinogen replacement in severe traumatic haemorrhage can be achieved quicker with a more
predictable dose response using Fibrinogen Concentrate compared to Cryoprecipitate 16. It is
imperative that robust and clinically relevant trials are performed to investigate fibrinogen
supplementation in paediatric trauma patients before widespread adoption makes performing
such studies unfeasible
Phase:
Phase 2
Details
Lead Sponsor:
Gold Coast Hospital and Health Service
Collaborators:
Australian Red Cross Emergency Medicine Foundation National Blood Authority