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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05449834




Registration number
NCT05449834
Ethics application status
Date submitted
5/07/2022
Date registered
8/07/2022
Date last updated
2/03/2023

Titles & IDs
Public title
Fibrinogen Early In Severe Trauma StudY II
Scientific title
Fibrinogen Early In Severe Trauma StudY II
Secondary ID [1] 0 0
ANZIC-RC/ZM001
Universal Trial Number (UTN)
Trial acronym
FEISTY II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Trauma 0 0
Haemorrhagic Shock 0 0
Coagulopathy 0 0
Condition category
Condition code
Blood 0 0 0 0
Other blood disorders
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Fibrinogen Concentrate
Other interventions - Cryoprecipitate

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

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


Treatment: Drugs: Fibrinogen Concentrate
3g Fibrinogen Concentrate

Other interventions: Cryoprecipitate
10U WB or 4U Apheresis Cryoprecipitate
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Days Alive and Out of Hospital at 90 Days
Timepoint [1] 0 0
90 Days
Secondary outcome [1] 0 0
Number RBC Units at 24 hours
Timepoint [1] 0 0
24 hours
Secondary outcome [2] 0 0
All cause mortality at 90 days
Timepoint [2] 0 0
90 days
Secondary outcome [3] 0 0
All cause mortality at 6 and 24 hours
Timepoint [3] 0 0
24 hours
Secondary outcome [4] 0 0
Death from haemorrhage at 6 and 24 hours
Timepoint [4] 0 0
24 hours
Secondary outcome [5] 0 0
Ventilator free days up to day 28
Timepoint [5] 0 0
28 days
Secondary outcome [6] 0 0
Symptomatic thromboembolic events to 28 days
Timepoint [6] 0 0
28 days
Secondary outcome [7] 0 0
Quality of life at 3, 6 and 12 months
Timepoint [7] 0 0
12 Months
Secondary outcome [8] 0 0
Health and disability at 3, 6 and 12 months
Timepoint [8] 0 0
12 months
Secondary outcome [9] 0 0
Functional outcome (Patients with TBI) at 12 months
Timepoint [9] 0 0
12 months
Secondary outcome [10] 0 0
Organ failure assessment
Timepoint [10] 0 0
28 days

Eligibility
Key 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
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
850
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA
Recruitment hospital [1] 0 0
Gold Coast University Hospital - Gold Coast
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
4215 - Gold Coast
Recruitment postcode(s) [2] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
Australian and New Zealand Intensive Care Research Centre
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Blood Synergy Program
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Australian and New Zealand Intensive Care Society Clinical Trials Group
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Australasian College for Emergency Medicine
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Australian Red Cross Lifeblood
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Australasian Trauma Society
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

Summary
Brief 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
Trial website
https://clinicaltrials.gov/ct2/show/NCT05449834
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Zoe McQuilten, MBBS
Address 0 0
Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
James Winearls, MBBS
Address 0 0
Country 0 0
Phone 0 0
+61399030379
Fax 0 0
Email 0 0
james.winearls@health.qld.gov.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05449834