AzTrials
AzTrials

TraumaPhase 2FEISTYNCT02745041

Fibrinogen Early In Severe Trauma studY

A Phase 2 study testing Fibrinogen Concentrate and Cryoprecipitate in people with Trauma and Haemorrhage, run by Gold Coast Hospital and Health Service at 4 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Trauma, Haemorrhage, Coagulopathy
What is being tested?
Fibrinogen Concentrate and Cryoprecipitate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
4 sitesAustralia
Study dates
Dec 2016to 20 Feb 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country.

Australia4 sites

  • Royal Brisbane and Women's Hospital

    Brisbane, Queensland, 4029

  • Princess Alexandra Hospital

    Brisbane, Queensland, 4102

  • Gold Coast University Hospital

    Gold Coast, Queensland, 4215

  • Townsville Hospital

    Townsville, Queensland, 4814

Other trials in Australia

About this study

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

  • 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
Being tested
Fibrinogen Concentrate, Cryoprecipitate
Keywords
Fibrinogen, Cryoprecipitate
Medical subject headings
Wounds and Injuries, Hemorrhage, Hemostatic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fibrinogen ConcentrateDrug

    Also called RIASTAP

    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

  • CryoprecipitateOther

    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

Study groups in NCT02745041
Study groupRoleWhat they receive
Fibrinogen ConcentrateExperimentalFibrinogen Replacement using Fibrinogen Concentrate as per ROTEM guided treatment algorithm [FIBTEM ≤ A5 10mm]
Receives: Drug: Fibrinogen Concentrate
CryoprecipitateActive comparatorFibrinogen replacement using Cryoprecipitate as per ROTEM guided treatment algorithm [FIBTEM A5 ≤ 10mm]
Receives: Other: Cryoprecipitate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to administration of Fibrinogen Replacement from time of ROTEM analysis indicating fibrinogen supplementation is required First dose of Fibrinogen Concentrate or Cryoprecipitate required

    It is anticipated that fibrinogen replacement will occur with 3 hours Fibrinogen replacement will be with either FC or Cryroprecipitate depending on randomisation

    Measured: 3 Hours

  2. Feasibility of administering FC within 30 mins of clinical scenario and ROTEM analysis suggesting Fibrinogen replacement is required

    Proportion of patients receiving FC within 30 minutes

    Measured: 3 Hours

  3. Effects on Fibrinogen levels during traumatic haemorrhage as measured by Clauss Fibrinogen

    Blood sampling will occur for 7 days after admission/randomisation

    Measured: 7 Days

  4. Effects on Fibrinogen levels during traumatic haemorrhage as measured by FIBTEM

    Blood sampling will occur for 7 days after admission/randomisation

    Measured: 7 Days

Secondary outcomes (6)

  1. Transfusion Requirements

    In number of units of Packed Red Blood Cells, Plasma, FC, Cryoprecipitate, Platelets, Prothrombin Complex Concentrate at 4, 6, 24, 48hrs

    Measured: 48 hours

  2. Duration of bleeding episode or time until surgical control

    It is anticipated that haemorrhage control will be achieved within 12 hours

    Measured: 12 hours

  3. Intensive Care Unit Length of stay

    Measured: 1 Year

  4. Hospital Length of Stay

    Measured: 1 Year

  5. Adverse Events

    Transfusion related adverse events Sepsis Multiple Organ Failure Acute Renal Failure Thromboembolic Complications

    Measured: 1Year

  6. All cause Mortality

    Mortality at 4, 6, 24 hours and up to 90 days

    Measured: 90 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2016 (estimated)
  2. Study startDec 2016
  3. Primary completion20 Jan 2018
  4. Study completion20 Feb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02745041
Sponsor's protocol ID
FEISTY-1
Acronym
FEISTY
Status last verified
Mar 2018
First submitted
5 Apr 2016
Last updated
5 Mar 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 36163263

  • 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.

    PubMed 28549445

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fibrinogen Concentrate and Cryoprecipitate in people with Trauma and Haemorrhage, run by Gold Coast Hospital and Health Service at 4 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: 3 Hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02745041, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2018.

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