Early fibrinogen replacement in severe trauma patients
Fibrinogen Early In Severe Trauma StudY II
This study tests if giving fibrinogen early to adults with severe trauma and heavy bleeding can help them stop bleeding and recover better.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 900 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Australian and New Zealand Intensive Care Research Centre Academic / other |
| Locations | 24 sites (Newcastle, New South Wales and 23 other locations) |
| Trial ID | NCT05449834 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of early fibrinogen replacement using either fibrinogen concentrate or cryoprecipitate in adults suffering from severe trauma and active hemorrhage. The study aims to determine if timely administration of fibrinogen can improve clot formation and reduce bleeding, thereby enhancing patient outcomes. Participants will be adults aged 18 and over who meet specific criteria related to their trauma and coagulation status. The trial is designed to assess the efficacy of these interventions in a critical care setting.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have sustained severe trauma and are actively bleeding.
Not a fit: Patients with injuries deemed incompatible with survival or those who have known coagulation disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce mortality and improve recovery outcomes for trauma patients experiencing hemorrhagic shock.
How similar studies have performed: Previous studies have indicated that early replacement of clotting factors can improve outcomes in trauma patients, suggesting a promising approach in this trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Newcastle, New South Wales and 23 other locations
- John Hunter Hospital — Newcastle, New South Wales, Australia (Recruiting)
- St Vincent's Hospital — Sydney, New South Wales, Australia (Recruiting)
- Royal Prince Alfred Hospital — Sydney, New South Wales, Australia (Recruiting)
- Royal North Shore Hospital — Sydney, New South Wales, Australia (Recruiting)
- Westmead Hospital — Sydney, New South Wales, Australia (Recruiting)
- Liverpool Hospital — Sydney, New South Wales, Australia (Recruiting)
- Royal Darwin Hospital — Darwin, Northern Territory, Australia (Recruiting)
- Royal Brisbane and Women's Hospital — Brisbane, Queensland, Australia (Recruiting)
- Princess Alexandra Hospital — Brisbane, Queensland, Australia (Recruiting)
- Cairns Hospital — Cairns, Queensland, Australia (Recruiting)
- Gold Coast University Hospital — Gold Coast, Queensland, Australia (Recruiting)
- Rockhampton Hospital — Rockhampton, Queensland, Australia (Recruiting)
- Sunshine Coast University Hospital — Sunshine Coast, Queensland, Australia (Recruiting)
- Townsville Hospital — Townsville, Queensland, Australia (Recruiting)
- Royal Adelaide Hospital — Adelaide, South Australia, Australia (Recruiting)
- Flinders Medical Centre — Adelaide, South Australia, Australia (Recruiting)
- Royal Hobart Hospital — Hobart, Tasmania, Australia (Recruiting)
- Alfred Hospital — Melbourne, Victoria, Australia (Recruiting)
- Royal Melbourne Hospital — Melbourne, Victoria, Australia (Recruiting)
- Royal Perth Hospital — Perth, Western Australia, Australia (Recruiting)
- Aukland City Hospital — Auckland, Aukland, New Zealand (Not_yet_recruiting)
- Middlemore Hospital — Auckland, Aukland, New Zealand (Not_yet_recruiting)
- Waikato Hospital — Hamilton, Hamilton, New Zealand (Recruiting)
- Wellington Hospital — Wellington, Wellington Region, New Zealand (Recruiting)
Study contacts
- Principal investigator: Zoe McQuilten, MBBS — Monash University
- Study coordinator: James Winearls, MBBS
- Email: james.winearls@health.qld.gov.au
- Phone: +61399030379
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.