NCT03508141

Fibrinogen Early In Severe Trauma studY Junior

Fibrinogen Concentrate vs Cryoprecipitate in Traumatic Haemorrhage in Children: A Pilot Randomised Controlled Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Gold Coast Hospital and Health Service · Other Government
• Sex: All
• Age: 3 Months – 18 Years
• Healthy volunteers: Not accepted

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 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

Conditions

• Trauma
• Hemorrhage
• Coagulopathy
• Pediatrics

Interventions

Type	Name	Description
DRUG	Fibrinogen Concentrate	Experimental
DRUG	Cryoprecipitate	Comparator

Timeline

• Start date: 2018-07-01
• Primary completion: 2021-06-30
• Completion: 2021-06-30
• First posted: 2018-04-25
• Last updated: 2020-06-29

Locations

10 sites across 1 country: Australia