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New treatment option for Trauma
Official title Fibrinogen Early In Severe Trauma StudY II
ClinicalTrials.gov ID: NCT05449834
What this study is testing
What is Fibrinogen Concentrate?
Fibrinogen Concentrate is an investigational medicine, being studied as a potential treatment for trauma.
Also referred to as Riastap.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join 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 likely can't join 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
See the full eligibility criteria
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Newcastle, New South Wales, Australia
- Sydney, New South Wales, Australia
- Darwin, Northern Territory, Australia
- Brisbane, Queensland, Australia
- Cairns, Queensland, Australia
- Gold Coast, Queensland, Australia
- Rockhampton, Queensland, Australia
- Sunshine Coast, Queensland, Australia
- Townsville, Queensland, Australia
- Adelaide, South Australia, Australia
- Hobart, Tasmania, Australia
- Melbourne, Victoria, Australia
- Perth, Western Australia, Australia
- Auckland, Aukland, New Zealand
- Hamilton, Hamilton, New Zealand
- Wellington, Wellington Region, New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Newcastle, New South Wales, Australia; Sydney, New South Wales, Australia; Darwin, Northern Territory, Australia; Brisbane, Queensland, Australia; Cairns, Queensland, Australia; Gold Coast, Queensland, Australia and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.