Fibrinogen Early In Severe Trauma studY

• Status: Completed
• Trial end date: 2018-02-20
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gold Coast Hospital and Health Service
• Collaborators: Australian Red Cross; Emergency Medicine Foundation; National Blood Authority

Criteria

Inclusion Criteria:

1. Adult affected by Trauma (>18yrs) and

2. Judged to have significant haemorrhage or

3. Predicted to require significant transfusion with ABC Score ≥ 2 or by treating clinician judgement

Exclusion Criteria:

1. Injury judged incompatible with survival

2. Pregnancy

3. Known objection to blood products

4. Previous Fibrinogen replacement this admission

5. Pre-Trauma Centre fibrinogen replacement

6. Participation in competing study