TraumaPhase 3FEISTY IINCT05449834
Fibrinogen Early In Severe Trauma StudY II
A Phase 3 study testing Fibrinogen Concentrate and Cryoprecipitate in people with Trauma and Haemorrhagic Shock, run by Australian and New Zealand Intensive Care Research Centre at 24 sites in 2 countries.
Trial summary
Annually over 7000 Australians are treated for severe trauma. Haemorrhage secondary to severe trauma is a major cause of potentially preventable death and poor outcomes in Australian adults. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Trauma, Haemorrhagic Shock, Coagulopathy
- What is being tested?
- Fibrinogen Concentrate and Cryoprecipitate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 24 sitesin 2 countries
- Study dates
- 21 Nov 2022to 15 Jul 2026
- Phase
- Phase 3
- 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)
- Judged to have active haemorrhage by treating clinician
- Activation of local MHP and/or Transfusion of Emergency Blood Products
- FIBTEM A5 ≤ 10mm or TEG FF A5 ≤ 15mm or FibC ≤ 2 g/l
Who cannot join
- Injury judged incompatible with survival
- Randomisation unable to occur within 6 hours of presentation to hospital
- Known pregnancy
- Known genetic or drug induced coagulation disorder
- Known objection to blood products
- Dedicated prior fibrinogen replacement
- Participation in a competing study
Trial locations and contacts
24 sites in 2 countries.
24 sites in 2 countries
Australia20 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Flinders Medical Centre
Adelaide, South Australia, 5042
Royal Brisbane and Women's Hospital
Brisbane, Queensland, 4006
Princess Alexandra Hospital
Brisbane, Queensland, 4102
Cairns Hospital
Cairns, Queensland, 4870
Royal Darwin Hospital
Darwin, Northern Territory, 0810
Gold Coast University Hospital
Gold Coast, Queensland, 4215
Royal Hobart Hospital
Hobart, Tasmania, 7000
Alfred Hospital
Melbourne, Victoria, 3004
Royal Melbourne Hospital
Melbourne, Victoria, 3050
John Hunter Hospital
Newcastle, New South Wales, 2305
Royal Perth Hospital
Perth, Western Australia, 6000
Rockhampton Hospital
Rockhampton, Queensland, 4700
Sunshine Coast University Hospital
Sunshine Coast, Queensland, 4575
St Vincent's Hospital
Sydney, New South Wales, 2010
Royal Prince Alfred Hospital
Sydney, New South Wales, 2050
Royal North Shore Hospital
Sydney, New South Wales, 2065
Westmead Hospital
Sydney, New South Wales, 2145
Liverpool Hospital
Sydney, New South Wales, 2170
Townsville Hospital
Townsville, Queensland, 4814
New Zealand4 sites
Aukland City Hospital
Auckland, Aukland, 1023
Middlemore Hospital
Auckland, Aukland, 2025
Waikato Hospital
Hamilton, Hamilton, 3204
Wellington Hospital
Wellington, Wellington Region, 6021
About this study
Annually over 7000 Australians are treated for severe trauma. Haemorrhage secondary to severe trauma is a major cause of potentially preventable death and poor outcomes in Australian adults. Severe trauma may trigger changes in blood clotting mechanisms and factor levels leading to inhibition of clot formation and reduced clot strength. This results in the inability of the severely injured trauma patient to form adequate clots to help stop bleeding. There is good evidence to suggest the loss of clotting factors during haemorrhage is associated with worse outcomes and it is thought the early replacement of these factors may reduce bleeding and improve patient outcomes. Fibrinogen is a key clotting factor that helps bind clots together and early fibrinogen replacement may improve outcomes.
Currently fibrinogen is replaced using cryoprecipitate, a blood product made from blood donated by healthy donors which is a precious resource. It can take a significant amount of time to administer as it is frozen and stored in the blood bank. Timely administration of cryoprecipitate is difficult as it requires thawing prior to transfusion. The large doses of cryoprecipitate used in traumatic haemorrhage can put strain on local blood banks in supplying requested units in a timely manner. Additionally, the widely dispersed population of Australia introduces logistic challenges to the maintenance of adequate cryoprecipitate stocks to individual hospital blood banks, especially in remote regions. However, cryoprecipitate contains a number of other coagulation factors (not just fibrinogen) that may be instrumental in clot formation and resistance to fibrinolysis.
Read more
Fibrinogen concentrate is an alternative product used to assist in blood clotting. It is a dry powder form of fibrinogen and can be reconstituted at the bedside and given quickly. The use of a fibrinogen factor concentrate with a long shelf life that is easy to use has significant implications for both large urban metropolitan areas and remote isolated communities.
The timing and mode of fibrinogen replacement in traumatic haemorrhage has implications for patient outcomes, blood product availability, costs and the national blood supply. Despite the importance of fibrinogen replacement in traumatic haemorrhage, there have been no clinical trials powered for clinical outcomes directly comparing fibrinogen concentrate and cryoprecipitate. FEISTY II will evaluate the efficacy, safety and cost-effectiveness of Fibrinogen Concentrate vs Cryoprecipitate in trauma patients with major haemorrhage.
FEISTY II is a phase III randomised trial which will enrol 850 patients from Australian and New Zealand major trauma centres, with a primary patient outcome of days alive out of hospital at day 90 after injury. Severely injured trauma patients who require blood transfusion and have evidence of low fibrinogen levels will be randomised to receive either fibrinogen concentrate or standard care with cryoprecipitate
- Conditions
- Trauma, Haemorrhagic Shock, Coagulopathy
- Being tested
- Fibrinogen Concentrate, Cryoprecipitate
- Keywords
- Fibrinogen, Cryoprecipitate
- Medical subject headings
- Wounds and Injuries, Shock, Hemorrhagic, 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
3g Fibrinogen Concentrate
CryoprecipitateOther
10U WB or 4U Apheresis Cryoprecipitate
| Study group | Role | What they receive |
|---|---|---|
| Fibrinogen Concentrate (FC) | Experimental | Fibrinogen Replacement using 3g Fibrinogen Concentrate as per:
ROTEM FIBTEM A5 ≤ 10mm or TEG FF A10 ≤ 15mm or FibC ≤ 2g/L Receives: Drug: Fibrinogen Concentrate |
| Cryoprecipitate (Cryo) | Active comparator | Fibrinogen Replacement using 10 Units WB or 4U Apheresis Cryo (Australia) as per:
ROTEM FIBTEM A5 ≤ 10mm or TEG FF A10 ≤ 15mm or FibC ≤ 2g/L Receives: Other: Cryoprecipitate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days Alive and Out of Hospital at 90 Days
DAOH 90
Measured: 90 Days
Secondary outcomes (10)
Number RBC Units at 24 hours
Red Blood Cells
Measured: 24 hours
All cause mortality at 90 days
Mortality at Day 90
Measured: 90 days
All cause mortality at 6 and 24 hours
Mortality at 6 and 24 hours
Measured: 24 hours
Death from haemorrhage at 6 and 24 hours
Haemorrhage as cause of death at 6 and 24 hours
Measured: 24 hours
Ventilator free days up to day 28
VFD 28 days
Measured: 28 days
Symptomatic thromboembolic events to 28 days
Venous and Arterial Thrombotic events
Measured: 28 days
Quality of life at 3, 6 and 12 months
EQ5D-5L European Quality of Life 5 Dimensions 5 Levels Scored 0-100, where 0 = Worst QOL and 100 = Best QOL
Measured: 12 Months
Health and disability at 3, 6 and 12 months
WHODAS 2.0 World Health Organisation Disability and Assessment Schedule 2.0 Scored 0-100, where 0 = No Disability and 100 = Full Disbility
Measured: 12 months
Functional outcome (Patients with TBI) at 12 months
GOSE Glasgow Outcome Scale Extended Scored 1-8, where 1 = Death and 8 = Upper Good Recovery
Measured: 12 months
Organ failure assessment
Denver MOF Score Denver Multiple Organ Failure Score Scored 0-12, where 0 = No Organ Failure and 12 = Severe MOF
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start21 Nov 2022
- Primary completion15 Jul 2026
- Study completion15 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective phase III, multi-centre, randomised, controlled, two arm parallel, open label trial evaluating the effect of FC compared to standard care (Cryo) in severely injured bleeding adult trauma patients with major haemorrhage and hypofibrinogenemia.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Australian and New Zealand Intensive Care Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Blood Synergy Program, Australian and New Zealand Intensive Care Society Clinical Trials Group, Australasian College for Emergency Medicine, Australian Red Cross Lifeblood, Australasian Trauma Society
- Responsible party
- Sponsor
- Investigators
- Zoe McQuilten, MBBS, Principal investigator, Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05449834
- Sponsor's protocol ID
- ANZIC-RC/ZM001
- Acronym
- FEISTY II
- Status last verified
- Sep 2026
- First submitted
- 5 Jul 2022
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No current plan to make IPD available
Publications
Fatovich DM, Carey S, Iliff J, Jowitt T, Weber DG, Vance JS. Integrating Research Practice Into Resuscitation Simulation Training Improves Recruitment Into Complex Clinical Trials. Emerg Med Australas. 2025 Jun;37(3):e70064. doi: 10.1111/1742-6723.70064.
PubMed 40420619
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fibrinogen Early In Severe Trauma StudY II
- ClinicalTrials.gov ID
- NCT05449834
- Acronym / sponsor ID
- FEISTY II / ANZIC-RC/ZM001
- Conditions
- Trauma, Haemorrhagic Shock, Coagulopathy
- Keywords
- Fibrinogen, Cryoprecipitate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- Australian and New Zealand Intensive Care Research CentreUniversity, hospital or other
- Collaborators
- Blood Synergy Program, Australian and New Zealand Intensive Care Society Clinical Trials Group, Australasian College for Emergency Medicine, Australian Red Cross Lifeblood, Australasian Trauma Society
- Study start
- 21 Nov 2022 (actual)
- Primary completion
- 15 Jul 2026 (actual)
- Study completion
- 15 Jul 2026 (actual)
- First posted
- 8 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Annually over 7000 Australians are treated for severe trauma. Haemorrhage secondary to severe trauma is a major cause of potentially preventable death and poor outcomes in Australian adults. Severe trauma may trigger changes in blood clotting mechanisms and factor levels leading to inhibition of clot formation and reduced clot strength. This results in the inability of the severely injured trauma patient to form adequate clots to help stop bleeding. There is good evidence to suggest the loss of clotting factors during haemorrhage is associated with worse outcomes and it is thought the early replacement of these factors may reduce bleeding and improve patient outcomes. Fibrinogen is a key clotting factor that helps bind clots together and early fibrinogen replacement may improve outcomes.
Currently fibrinogen is replaced using cryoprecipitate, a blood product made from blood donated by healthy donors which is a precious resource. It can take a significant amount of time to administer as it is frozen and stored in the blood bank. Timely administration of cryoprecipitate is difficult as it requires thawing prior to transfusion. The large doses of cryoprecipitate used in traumatic haemorrhage can put strain on local blood banks in supplying requested units in a timely manner. Additionally, the widely dispersed population of Australia introduces logistic challenges to the maintenance of adequate cryoprecipitate stocks to individual hospital blood banks, especially in remote regions. However, cryoprecipitate contains a number of other coagulation factors (not just fibrinogen) that may be instrumental in clot formation and resistance to fibrinolysis.
Fibrinogen concentrate is an alternative product used to assist in blood clotting. It is a dry powder form of fibrinogen and can be reconstituted at the bedside and given quickly. The use of a fibrinogen factor concentrate with a long shelf life that is easy to use has significant implications for both large urban metropolitan areas and remote isolated communities.
The timing and mode of fibrinogen replacement in traumatic haemorrhage has implications for patient outcomes, blood product availability, costs and the national blood supply. Despite the importance of fibrinogen replacement in traumatic haemorrhage, there have been no clinical trials powered for clinical outcomes directly comparing fibrinogen concentrate and cryoprecipitate. FEISTY II will evaluate the efficacy, safety and cost-effectiveness of Fibrinogen Concentrate vs Cryoprecipitate in trauma patients with major haemorrhage.
FEISTY II is a phase III randomised trial which will enrol 850 patients from Australian and New Zealand major trauma centres, with a primary patient outcome of days alive out of hospital at day 90 after injury. Severely injured trauma patients who require blood transfusion and have evidence of low fibrinogen levels will be randomised to receive either fibrinogen concentrate or standard care with cryoprecipitate
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective phase III, multi-centre, randomised, controlled, two arm parallel, open label trial evaluating the effect of FC compared to standard care (Cryo) in severely injured bleeding adult trauma patients with major haemorrhage and hypofibrinogenemia.
| Arm | Type | Receives |
|---|---|---|
| Fibrinogen Concentrate (FC) | Experimental | Drug: Fibrinogen ConcentrateFibrinogen Replacement using 3g Fibrinogen Concentrate as per: ROTEM FIBTEM A5 ≤ 10mm or TEG FF A10 ≤ 15mm or FibC ≤ 2g/L |
| Cryoprecipitate (Cryo) | Active comparator | Other: CryoprecipitateFibrinogen Replacement using 10 Units WB or 4U Apheresis Cryo (Australia) as per: ROTEM FIBTEM A5 ≤ 10mm or TEG FF A10 ≤ 15mm or FibC ≤ 2g/L |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult affected by trauma (≥18yrs)
- Judged to have active haemorrhage by treating clinician
- Activation of local MHP and/or Transfusion of Emergency Blood Products
- FIBTEM A5 ≤ 10mm or TEG FF A5 ≤ 15mm or FibC ≤ 2 g/l
Key exclusion criteria (7 listed)
- Injury judged incompatible with survival
- Randomisation unable to occur within 6 hours of presentation to hospital
- Known pregnancy
- Known genetic or drug induced coagulation disorder
- Known objection to blood products
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fibrinogen ConcentrateAlso: Riastap3g Fibrinogen Concentrate | Drug | Fibrinogen Concentrate (FC) |
| Cryoprecipitate10U WB or 4U Apheresis Cryoprecipitate | Other | Cryoprecipitate (Cryo) |
Primary outcome
Days Alive and Out of Hospital at 90 Days
Time frame: 90 Days
DAOH 90
10 secondary outcomes
Number RBC Units at 24 hours
Time frame: 24 hours
All cause mortality at 90 days
Time frame: 90 days
All cause mortality at 6 and 24 hours
Time frame: 24 hours
Death from haemorrhage at 6 and 24 hours
Time frame: 24 hours
Ventilator free days up to day 28
Time frame: 28 days
Symptomatic thromboembolic events to 28 days
Time frame: 28 days
Quality of life at 3, 6 and 12 months
Time frame: 12 Months
Health and disability at 3, 6 and 12 months
Time frame: 12 months
Functional outcome (Patients with TBI) at 12 months
Time frame: 12 months
Organ failure assessment
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Derived from this study: PubMed 40420619Fatovich DM, Carey S, Iliff J, Jowitt T, Weber DG, Vance JS. Integrating Research Practice Into Resuscitation Simulation Training Improves Recruitment Into Complex Clinical Trials. Emerg Med Australas. 2025 Jun;37(3):e70064. doi: 10.1111/1742-6723.70064.
- Individual participant dataSharing planned: No. No current plan to make IPD available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zoe McQuilten, MBBS principal investigator
Monash University
24 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fibrinogen Concentrate and Cryoprecipitate in people with Trauma and Haemorrhagic Shock, run by Australian and New Zealand Intensive Care Research Centre at 24 sites in 2 countries.
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 4 inclusion and 7 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 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Australia, New Zealand. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Days Alive and Out of Hospital at 90 Days (time frame: 90 Days). 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 NCT05449834, which also lists 1 linked publication.
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 9 Sep 2026; AzTrials last refreshed its copy on 1 Nov 2026.