Fibrinogen Early In Severe Trauma StudY II

Trauma Clinical Trial

— FEISTY II  

Official title:

Fibrinogen Early In Severe Trauma StudY II

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05449834
• Other study ID #: ANZIC-RC/ZM001
• Status: Recruiting
• Phase: Phase 3
• Start date: November 21, 2022
• Est. completion date: December 1, 2026

Study information

• Verified date: February 2023
• Source: Australian and New Zealand Intensive Care Research Centre
• Contact: James Winearls, MBBS
• Phone: +61399030379
• Email: james.winearls[@]health.qld.gov.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 850
• Est. completion date: December 1, 2026
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Coagulopathy
• Haemorrhagic Shock
• Shock, Hemorrhagic
• Trauma
• Wounds and Injuries

Intervention

Drug:
• Fibrinogen Concentrate
3g Fibrinogen Concentrate

Other:
• Cryoprecipitate
10U WB or 4U Apheresis Cryoprecipitate

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Gold Coast University Hospital	Gold Coast	Queensland

Sponsors (6)

Lead Sponsor	Collaborator
Australian and New Zealand Intensive Care Research Centre	Australasian College for Emergency Medicine, Australasian Trauma Society, Australian and New Zealand Intensive Care Society Clinical Trials Group, Australian Red Cross Lifeblood, Blood Synergy Program

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days Alive and Out of Hospital at 90 Days	DAOH 90	90 Days
Secondary	Number RBC Units at 24 hours	Red Blood Cells	24 hours
Secondary	All cause mortality at 90 days	Mortality at Day 90	90 days
Secondary	All cause mortality at 6 and 24 hours	Mortality at 6 and 24 hours	24 hours
Secondary	Death from haemorrhage at 6 and 24 hours	Haemorrhage as cause of death at 6 and 24 hours	24 hours
Secondary	Ventilator free days up to day 28	VFD 28 days	28 days
Secondary	Symptomatic thromboembolic events to 28 days	Venous and Arterial Thrombotic events	28 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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