Fibrinogen Early In Severe Trauma studY Junior

  • STATUS
    Recruiting
  • End date
    Jun 30, 2021
  • participants needed
    44
  • sponsor
    Gold Coast Hospital and Health Service
Updated on 5 July 2020
coagulopathy
resuscitation
blood transfusion
fibrinogen
cryoprecipitate
traumatic hemorrhage
viral inactivation

Summary

  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
  11. 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

Details
Treatment Fibrinogen concentrate, Cryoprecipitate
Clinical Study IdentifierNCT03508141
SponsorGold Coast Hospital and Health Service
Last Modified on5 July 2020

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Eligibility

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Inclusion Criteria

Is your age between 1 yrs and 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Hemorrhage or Wounds or Coagulopathy or Trauma or Pediatrics or Wounds - qualifier?
Child affected by trauma (3 months to 18 years)
Judged to have significant haemorrhage OR predicted to require significant transfusion by the treating clinician
Activation of Local MHP or transfusion of emergency red blood cells (Pre-hospital or at Trauma Centre)

Exclusion Criteria

Injury judged incompatible with survival
Randomisation unable to occur within 6 hours of hospital admission
Pregnancy
Known personal or parental objection to blood products
Known coagulation disorder (i.e. haemophilia, von Willebrand disease)
Previous dedicated fibrinogen replacement this admission
Pre-Trauma Centre dedicated fibrinogen replacement
Participation in competing study
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