Clinical trial NCT02745041: Fibrinogen Early In Severe Trauma studY
Official title: Fibrinogen Concentrate vs Cryoprecipitate in Traumatic Haemorrhage: A Pilot Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Trauma
Haemorrhage
Coagulopathy
Keywords: Fibrinogen
Cryoprecipitate
Lead sponsor: Gold Coast Hospital and Health Service
Sponsor class: OTHER_GOV
Collaborators: name: Emergency Medicine Foundation
name: National Blood Authority
name: Australian Red Cross
First posted: 2016-04-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility 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

Primary outcomes:
measure: Time to administration of Fibrinogen Replacement from time of ROTEM analysis indicating fibrinogen supplementation is required First dose of Fibrinogen Concentrate or Cryoprecipitate required
timeFrame: 3 Hours
measure: Feasibility of administering FC within 30 mins of clinical scenario and ROTEM analysis suggesting Fibrinogen replacement is required
timeFrame: 3 Hours
measure: Effects on Fibrinogen levels during traumatic haemorrhage as measured by Clauss Fibrinogen
timeFrame: 7 Days
measure: Effects on Fibrinogen levels during traumatic haemorrhage as measured by FIBTEM
timeFrame: 7 Days
Secondary outcomes:
measure: Transfusion Requirements
timeFrame: 48 hours
measure: Duration of bleeding episode or time until surgical control
timeFrame: 12 hours
measure: Intensive Care Unit Length of stay
timeFrame: 1 Year
measure: Hospital Length of Stay
timeFrame: 1 Year
measure: Adverse Events
timeFrame: 1Year
measure: All cause Mortality
timeFrame: 90 Days
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Gold Coast
country: Australia
facility: Gold Coast University Hospital
state: Queensland
city: Townsville
country: Australia
facility: Townsville Hospital
state: Queensland
Study officials:
affiliation: Gold Coast University Hospital
name: James Winearls, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Morrow GB, Feller T, McQuilten Z, Wake E, Ariens RAS, Winearls J, Mutch NJ, Laffan MA, Curry N. Cryoprecipitate transfusion in trauma patients attenuates hyperfibrinolysis and restores normal clot structure and stability: Results from a laboratory sub-study of the FEISTY trial. Crit Care. 2022 Sep 26;26(1):290. doi: 10.1186/s13054-022-04167-x.
citation: Winearls J, Wullschleger M, Wake E, Hurn C, Furyk J, Ryan G, Trout M, Walsham J, Holley A, Cohen J, Shuttleworth M, Dyer W, Keijzers G, Fraser JF, Presneill J, Campbell D. Fibrinogen Early In Severe Trauma studY (FEISTY): study protocol for a randomised controlled trial. Trials. 2017 May 26;18(1):241. doi: 10.1186/s13063-017-1980-x.