Fibrinogen Early In Severe Trauma StudY II (FEISTY II)
Primary Purpose
Trauma, Haemorrhagic Shock, Coagulopathy
Status
Recruiting
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
Fibrinogen Concentrate
Cryoprecipitate
Sponsored by
About this trial
This is an interventional treatment trial for Trauma focused on measuring Fibrinogen, Cryoprecipitate
Eligibility Criteria
Inclusion 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
Exclusion Criteria:
- 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
Sites / Locations
- Gold Coast University HospitalRecruiting
- Royal Adelaide HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Fibrinogen Concentrate (FC)
Cryoprecipitate (Cryo)
Arm Description
Fibrinogen Replacement using 3g Fibrinogen Concentrate as per: ROTEM FIBTEM A5 ≤ 10mm or TEG FF A10 ≤ 15mm or FibC ≤ 2g/L
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
Outcomes
Primary Outcome Measures
Days Alive and Out of Hospital at 90 Days
DAOH 90
Secondary Outcome Measures
Number RBC Units at 24 hours
Red Blood Cells
All cause mortality at 90 days
Mortality at Day 90
All cause mortality at 6 and 24 hours
Mortality at 6 and 24 hours
Death from haemorrhage at 6 and 24 hours
Haemorrhage as cause of death at 6 and 24 hours
Ventilator free days up to day 28
VFD 28 days
Symptomatic thromboembolic events to 28 days
Venous and Arterial Thrombotic events
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
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
Functional outcome (Patients with TBI) at 12 months
GOSE Glasgow Outcome Scale Extended Scored 1-8, where 1 = Death and 8 = Upper Good Recovery
Organ failure assessment
Denver MOF Score Denver Multiple Organ Failure Score Scored 0-12, where 0 = No Organ Failure and 12 = Severe MOF
Full Information
NCT ID
NCT05449834
First Posted
July 5, 2022
Last Updated
February 28, 2023
Sponsor
Australian and New Zealand Intensive Care Research Centre
Collaborators
Blood Synergy Program, Australian and New Zealand Intensive Care Society Clinical Trials Group, Australasian College for Emergency Medicine, Australian Red Cross Lifeblood, Australasian Trauma Society
1. Study Identification
Unique Protocol Identification Number
NCT05449834
Brief Title
Fibrinogen Early In Severe Trauma StudY II
Acronym
FEISTY II
Official Title
Fibrinogen Early In Severe Trauma StudY II
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 21, 2022 (Actual)
Primary Completion Date
June 1, 2026 (Anticipated)
Study Completion Date
December 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Australian and New Zealand Intensive Care Research Centre
Collaborators
Blood Synergy Program, Australian and New Zealand Intensive Care Society Clinical Trials Group, Australasian College for Emergency Medicine, Australian Red Cross Lifeblood, Australasian Trauma Society
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma, Haemorrhagic Shock, Coagulopathy
Keywords
Fibrinogen, Cryoprecipitate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
A prospective phase III, multi-centre, randomised, controlled, two arm parallel, open label trial evaluating the effect of FC compared to standard care (Cryo) in severely injured bleeding adult trauma patients with major haemorrhage and hypofibrinogenemia.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
It is not possible to blind the treating clinician to the randomised arm assignment
Allocation
Randomized
Enrollment
850 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fibrinogen Concentrate (FC)
Arm Type
Experimental
Arm Description
Fibrinogen Replacement using 3g Fibrinogen Concentrate as per:
ROTEM FIBTEM A5 ≤ 10mm or TEG FF A10 ≤ 15mm or FibC ≤ 2g/L
Arm Title
Cryoprecipitate (Cryo)
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Fibrinogen Concentrate
Other Intervention Name(s)
Riastap
Intervention Description
3g Fibrinogen Concentrate
Intervention Type
Other
Intervention Name(s)
Cryoprecipitate
Intervention Description
10U WB or 4U Apheresis Cryoprecipitate
Primary Outcome Measure Information:
Title
Days Alive and Out of Hospital at 90 Days
Description
DAOH 90
Time Frame
90 Days
Secondary Outcome Measure Information:
Title
Number RBC Units at 24 hours
Description
Red Blood Cells
Time Frame
24 hours
Title
All cause mortality at 90 days
Description
Mortality at Day 90
Time Frame
90 days
Title
All cause mortality at 6 and 24 hours
Description
Mortality at 6 and 24 hours
Time Frame
24 hours
Title
Death from haemorrhage at 6 and 24 hours
Description
Haemorrhage as cause of death at 6 and 24 hours
Time Frame
24 hours
Title
Ventilator free days up to day 28
Description
VFD 28 days
Time Frame
28 days
Title
Symptomatic thromboembolic events to 28 days
Description
Venous and Arterial Thrombotic events
Time Frame
28 days
Title
Quality of life at 3, 6 and 12 months
Description
EQ5D-5L European Quality of Life 5 Dimensions 5 Levels Scored 0-100, where 0 = Worst QOL and 100 = Best QOL
Time Frame
12 Months
Title
Health and disability at 3, 6 and 12 months
Description
WHODAS 2.0 World Health Organisation Disability and Assessment Schedule 2.0 Scored 0-100, where 0 = No Disability and 100 = Full Disbility
Time Frame
12 months
Title
Functional outcome (Patients with TBI) at 12 months
Description
GOSE Glasgow Outcome Scale Extended Scored 1-8, where 1 = Death and 8 = Upper Good Recovery
Time Frame
12 months
Title
Organ failure assessment
Description
Denver MOF Score Denver Multiple Organ Failure Score Scored 0-12, where 0 = No Organ Failure and 12 = Severe MOF
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion 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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
James Winearls, MBBS
Phone
+61399030379
Email
james.winearls@health.qld.gov.au
First Name & Middle Initial & Last Name or Official Title & Degree
Bridget Ady
Phone
+61399056643
Email
bridget.ady@monash.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zoe McQuilten, MBBS
Organizational Affiliation
Monash University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gold Coast University Hospital
City
Gold Coast
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Wake
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dan Ellis
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No current plan to make IPD available
Learn more about this trial
Fibrinogen Early In Severe Trauma StudY II
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