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Fibrinogen Early In Severe Trauma studY — FEISTY  

Trauma Clinical Trial

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

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02745041
Study type Interventional
Source Gold Coast Hospital and Health Service
Contact
Status Completed
Phase Phase 2
Start date December 2016
Completion date February 20, 2018
View Details
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