NCT02745041

Fibrinogen Early In Severe Trauma studY

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Gold Coast Hospital and Health Service · Other Government
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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

Conditions

• Trauma
• Haemorrhage
• Coagulopathy

Interventions

Type	Name	Description
DRUG	Fibrinogen Concentrate	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
OTHER	Cryoprecipitate	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

Timeline

• Start date: 2016-12-01
• Primary completion: 2018-01-20
• Completion: 2018-02-20
• First posted: 2016-04-20
• Last updated: 2018-03-05

Locations

4 sites across 1 country: Australia