Fibrinogen Early In Severe Trauma StudY II

Launched by AUSTRALIAN AND NEW ZEALAND INTENSIVE CARE RESEARCH CENTRE · Jul 5, 2022

Keywords

ClinConnect Summary

The Fibrinogen Early In Severe Trauma Study II (FEISTY II) is a clinical trial designed to compare two treatments for severely injured patients experiencing major bleeding. The trial is looking at how well a quick-to-use product called fibrinogen concentrate works compared to the standard treatment, cryoprecipitate, which is a blood product that can take time to prepare and administer. The goal is to see which treatment helps patients recover better and get out of the hospital sooner after a traumatic injury.

To participate in this study, adults aged 18 and older who have suffered a traumatic injury and are actively bleeding may be eligible. Key factors for participation include having low levels of fibrinogen, which is crucial for blood clotting. If you join the study, you will be randomly assigned to receive either the fibrinogen concentrate or cryoprecipitate as part of your treatment. This research is important not only for improving patient care but also for ensuring that blood products are used efficiently in hospitals, especially in remote areas where resources can be limited.

Gender

ALL

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