Fibrinogen Early In Severe Trauma StudY II (FEISTY II)

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

Study Overview

• Status: Recruiting
• Conditions: Trauma; Coagulopathy; Haemorrhagic Shock
• Intervention / Treatment: Drug: Fibrinogen Concentrate; Other: Cryoprecipitate

• Study Type: Interventional
• Enrollment (Estimated): 900
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: James Winearls, MBBS; Phone Number: +61399030379; Email: james.winearls@health.qld.gov.au
• Study Contact Backup: Name: Bridget Ady; Phone Number: +61399056643; Email: bridget.ady@monash.edu

Study Locations

• Australia
  • New South Wales
    • Newcastle, New South Wales, Australia, 2305
      • Recruiting
      • John Hunter Hospital
    • Sydney, New South Wales, Australia, 2145
      • Recruiting
      • Westmead Hospital
    • Sydney, New South Wales, Australia, 2065
      • Recruiting
      • Royal North Shore Hospital
    • Sydney, New South Wales, Australia, 2050
      • Recruiting
      • Royal Prince Alfred Hospital
    • Sydney, New South Wales, Australia, 2170
      • Recruiting
      • Liverpool Hospital
    • Sydney, New South Wales, Australia, 2010
      • Recruiting
      • St Vincent's Hospital
  • Northern Territory
    • Darwin, Northern Territory, Australia, 0810
      • Recruiting
      • Royal Darwin Hospital
  • Queensland
    • Brisbane, Queensland, Australia, 4006
      • Recruiting
      • Royal Brisbane and Women's Hospital
    • Brisbane, Queensland, Australia, 4102
      • Recruiting
      • Princess Alexandra Hospital
    • Cairns, Queensland, Australia, 4870
      • Recruiting
      • Cairns Hospital
    • Gold Coast, Queensland, Australia, 4215
      • Recruiting
      • Gold Coast University Hospital
      • Contact: Elizabeth Wake
    • Rockhampton, Queensland, Australia, 4700
      • Recruiting
      • Rockhampton Hospital
    • Sunshine Coast, Queensland, Australia, 4575
      • Recruiting
      • Sunshine Coast University Hospital
    • Townsville, Queensland, Australia, 4814
      • Recruiting
      • Townsville Hospital
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Recruiting
      • Royal Adelaide Hospital
      • Contact: Dan Ellis
    • Adelaide, South Australia, Australia, 5042
      • Recruiting
      • Flinders Medical Centre
  • Tasmania
    • Hobart, Tasmania, Australia, 7000
      • Recruiting
      • Royal Hobart Hospital
  • Victoria
    • Melbourne, Victoria, Australia, 3050
      • Recruiting
      • Royal Melbourne Hospital
    • Melbourne, Victoria, Australia, 3004
      • Recruiting
      • Alfred Hospital
  • Western Australia
    • Perth, Western Australia, Australia, 6000
      • Recruiting
      • Royal Perth Hospital
• New Zealand
  • Aukland
    • Auckland, Aukland, New Zealand, 1023
      • Not yet recruiting
      • Aukland City Hospital
    • Auckland, Aukland, New Zealand, 2025
      • Not yet recruiting
      • Middlemore Hospital
  • Hamilton
    • Hamilton, Hamilton, New Zealand, 3204
      • Recruiting
      • Waikato Hospital
  • Wellington Region
    • Wellington, Wellington Region, New Zealand, 6021
      • Recruiting
      • Wellington Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fibrinogen Concentrate (FC); Fibrinogen Replacement using 3g Fibrinogen Concentrate as per: ROTEM FIBTEM A5 ≤ 10mm or TEG FF A10 ≤ 15mm or FibC ≤ 2g/L	Drug: Fibrinogen Concentrate; 3g Fibrinogen Concentrate; Other Names: Riastap
Active Comparator: Cryoprecipitate (Cryo); Fibrinogen 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	Other: Cryoprecipitate; 10U WB or 4U Apheresis Cryoprecipitate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Days Alive and Out of Hospital at 90 Days	DAOH 90	90 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number RBC Units at 24 hours	Red Blood Cells	24 hours
All cause mortality at 90 days	Mortality at Day 90	90 days
All cause mortality at 6 and 24 hours	Mortality at 6 and 24 hours	24 hours
Death from haemorrhage at 6 and 24 hours	Haemorrhage as cause of death at 6 and 24 hours	24 hours
Ventilator free days up to day 28	VFD 28 days	28 days
Symptomatic thromboembolic events to 28 days	Venous and Arterial Thrombotic events	28 days
Quality of life at 3, 6 and 12 months	EQ5D-5L European Quality of Life 5 Dimensions 5 Levels Scored 0-100, where 0 = Worst QOL and 100 = Best QOL	12 Months
Health and disability at 3, 6 and 12 months	WHODAS 2.0 World Health Organisation Disability and Assessment Schedule 2.0 Scored 0-100, where 0 = No Disability and 100 = Full Disbility	12 months
Functional outcome (Patients with TBI) at 12 months	GOSE Glasgow Outcome Scale Extended Scored 1-8, where 1 = Death and 8 = Upper Good Recovery	12 months
Organ failure assessment	Denver MOF Score Denver Multiple Organ Failure Score Scored 0-12, where 0 = No Organ Failure and 12 = Severe MOF	28 days

Collaborators and Investigators

• Sponsor: Australian and New Zealand Intensive Care Research Centre
• Collaborators: Australian and New Zealand Intensive Care Society Clinical Trials Group; Australasian College for Emergency Medicine; Blood Synergy Program; Australian Red Cross Lifeblood; Australasian Trauma Society
• Investigators: Principal Investigator: Zoe McQuilten, MBBS, Monash University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: July 5, 2022
• First Submitted That Met QC Criteria: July 5, 2022
• First Posted (Actual): July 8, 2022

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Fibrinogen; Cryoprecipitate
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Hemorrhage; Hematologic Diseases; Hemorrhagic Disorders; Shock; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Wounds and Injuries; Hemostatic Disorders; Shock, Hemorrhagic; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Blood Proteins; Acute-Phase Proteins; Blood Coagulation Factors; Protein Precursors; Fibrinogen; cryoprecipitate coagulum
• Other Study ID Numbers: ANZIC-RC/ZM001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No current plan to make IPD available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No