NCT05449834 Fibrinogen Early In Severe Trauma StudY II
| NCT ID | NCT05449834 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Australian and New Zealand Intensive Care Research Centre |
| Condition | Trauma |
| Study Type | INTERVENTIONAL |
| Enrollment | 900 participants |
| Start Date | 2022-11-21 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 900 participants in total. It began in 2022-11-21 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
Inclusion Criteria: 1. Adult affected by trauma (≥18yrs) 2. Judged to have active haemorrhage by treating clinician 3. Activation of local MHP and/or Transfusion of Emergency Blood Products 4. FIBTEM A5 ≤ 10mm or TEG FF A5 ≤ 15mm or FibC ≤ 2 g/l Exclusion Criteria: 1. Injury judged incompatible with survival 2. Randomisation unable to occur within 6 hours of presentation to hospital 3. Known pregnancy 4. Known genetic or drug induced coagulation disorder 5. Known objection to blood products 6. Dedicated prior fibrinogen replacement 7. Participation in a competing study
Contact & Investigator
Zoe McQuilten, MBBS
PRINCIPAL INVESTIGATOR
Monash University
Frequently Asked Questions
Who can join the NCT05449834 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Trauma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05449834 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 900 participants.
Is NCT05449834 currently recruiting?
Yes, NCT05449834 is actively recruiting participants. Contact the research team at james.winearls@health.qld.gov.au for enrollment information.
Where is the NCT05449834 trial being conducted?
This trial is being conducted at Newcastle, Australia, Sydney, Australia, Sydney, Australia, Sydney, Australia and 11 additional locations.
Who is sponsoring the NCT05449834 clinical trial?
NCT05449834 is sponsored by Australian and New Zealand Intensive Care Research Centre. The principal investigator is Zoe McQuilten, MBBS at Monash University. The trial plans to enroll 900 participants.