Fibrinogen Early In Severe Trauma StudY II
FEISTY II
1 other identifier
interventional
900
2 countries
24
Brief 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. 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2022
Typical duration for phase_3
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2022
CompletedFirst Posted
Study publicly available on registry
July 8, 2022
CompletedStudy Start
First participant enrolled
November 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
July 15, 2026
CompletedSeptember 9, 2026
September 1, 2026
3.6 years
July 5, 2022
September 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Days Alive and Out of Hospital at 90 Days
DAOH 90
90 Days
Secondary Outcomes (10)
Number RBC Units at 24 hours
24 hours
All cause mortality at 90 days
90 days
All cause mortality at 6 and 24 hours
24 hours
Death from haemorrhage at 6 and 24 hours
24 hours
Ventilator free days up to day 28
28 days
- +5 more secondary outcomes
Study Arms (2)
Fibrinogen Concentrate (FC)
EXPERIMENTALFibrinogen Replacement using 3g Fibrinogen Concentrate as per: ROTEM FIBTEM A5 ≤ 10mm or TEG FF A10 ≤ 15mm or FibC ≤ 2g/L
Cryoprecipitate (Cryo)
ACTIVE COMPARATORFibrinogen 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
Interventions
3g Fibrinogen Concentrate
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Australian and New Zealand Intensive Care Research Centrelead
- Blood Synergy Programcollaborator
- Australian and New Zealand Intensive Care Society Clinical Trials Groupcollaborator
- Australasian College for Emergency Medicinecollaborator
- Australian Red Cross Lifebloodcollaborator
- Australasian Trauma Societycollaborator
Study Sites (24)
John Hunter Hospital
Newcastle, New South Wales, 2305, Australia
St Vincent's Hospital
Sydney, New South Wales, 2010, Australia
Royal Prince Alfred Hospital
Sydney, New South Wales, 2050, Australia
Royal North Shore Hospital
Sydney, New South Wales, 2065, Australia
Westmead Hospital
Sydney, New South Wales, 2145, Australia
Liverpool Hospital
Sydney, New South Wales, 2170, Australia
Royal Darwin Hospital
Darwin, Northern Territory, 0810, Australia
Royal Brisbane and Women's Hospital
Brisbane, Queensland, 4006, Australia
Princess Alexandra Hospital
Brisbane, Queensland, 4102, Australia
Cairns Hospital
Cairns, Queensland, 4870, Australia
Gold Coast University Hospital
Gold Coast, Queensland, 4215, Australia
Rockhampton Hospital
Rockhampton, Queensland, 4700, Australia
Sunshine Coast University Hospital
Sunshine Coast, Queensland, 4575, Australia
Townsville Hospital
Townsville, Queensland, 4814, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Flinders Medical Centre
Adelaide, South Australia, 5042, Australia
Royal Hobart Hospital
Hobart, Tasmania, 7000, Australia
Alfred Hospital
Melbourne, Victoria, 3004, Australia
Royal Melbourne Hospital
Melbourne, Victoria, 3050, Australia
Royal Perth Hospital
Perth, Western Australia, 6000, Australia
Aukland City Hospital
Auckland, Aukland, 1023, New Zealand
Middlemore Hospital
Auckland, Aukland, 2025, New Zealand
Waikato Hospital
Hamilton, Hamilton, 3204, New Zealand
Wellington Hospital
Wellington, Wellington Region, 6021, New Zealand
Related Publications (1)
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.
PMID: 40420619DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zoe McQuilten, MBBS
Monash University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- It is not possible to blind the treating clinician to the randomised arm assignment
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2022
First Posted
July 8, 2022
Study Start
November 21, 2022
Primary Completion
July 15, 2026
Study Completion
July 15, 2026
Last Updated
September 9, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will not share
No current plan to make IPD available