Title

Fibrinogen Early In Severe Trauma studY
Fibrinogen Concentrate vs Cryoprecipitate in Traumatic Haemorrhage: A Pilot Randomised Controlled Trial
  • Phase

    Phase 2
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Study Participants

    100
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
Study Started
Dec 31
2016
Primary Completion
Jan 20
2018
Study Completion
Feb 20
2018
Last Update
Mar 05
2018

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 names: RIASTAP

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

Fibrinogen Concentrate Experimental

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

Cryoprecipitate Active Comparator

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

Criteria

Inclusion Criteria:

Adult affected by Trauma (>18yrs) and
Judged to have significant haemorrhage or
Predicted to require significant transfusion with ABC Score ≥ 2 or by treating clinician judgement

Exclusion Criteria:

Injury judged incompatible with survival
Pregnancy
Known objection to blood products
Previous Fibrinogen replacement this admission
Pre-Trauma Centre fibrinogen replacement
Participation in competing study
No Results Posted