Fibrinogen Early In Severe Trauma studY (FEISTY)

Gold Coast Hospital and Health Service

Status and phase: Completed; Phase 2

Conditions: Coagulopathy; Haemorrhage; Trauma

Treatments: Drug: Fibrinogen Concentrate; Other: Cryoprecipitate

Study type: Interventional

Funder types: Other

Identifiers

NCT02745041

FEISTY-1

Details and patient eligibility

About

• 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

Enrollment: 100 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Fibrinogen Concentrate

Experimental group

Description:

Fibrinogen Replacement using Fibrinogen Concentrate as per ROTEM guided treatment algorithm \[FIBTEM ≤ A5 10mm\]

Treatment:

Drug: Fibrinogen Concentrate

Cryoprecipitate

Active Comparator group

Description:

Fibrinogen replacement using Cryoprecipitate as per ROTEM guided treatment algorithm \[FIBTEM A5 ≤ 10mm\]

Treatment:

Other: Cryoprecipitate