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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02745041




Registration number
NCT02745041
Ethics application status
Date submitted
5/04/2016
Date registered
20/04/2016
Date last updated
5/03/2018

Titles & IDs
Public title
Fibrinogen Early In Severe Trauma studY
Scientific title
Fibrinogen Concentrate vs Cryoprecipitate in Traumatic Haemorrhage: A Pilot Randomised Controlled Trial
Secondary ID [1] 0 0
FEISTY-1
Universal Trial Number (UTN)
Trial acronym
FEISTY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Trauma 0 0
Haemorrhage 0 0
Coagulopathy 0 0
Condition category
Condition code

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

Experimental: Fibrinogen Concentrate - Fibrinogen Replacement using Fibrinogen Concentrate as per ROTEM guided treatment algorithm [FIBTEM = A5 10mm]

Active Comparator: Cryoprecipitate - Fibrinogen replacement using Cryoprecipitate as per ROTEM guided treatment algorithm [FIBTEM A5 = 10mm]


Treatment: Drugs: Fibrinogen Concentrate
Fibrinogen Replacement using Fibrinogen Concentrate as per ROTEM guided treatment algorithm [FIBTEM = A5 10mm]
FIBTEM A5 0mm (Flat Line) = 6g FC FIBTEM A5 1 - 4mm = 5g FC FIBTEM A5 5 - 6mm = 4g FC FIBTEM A5 7 - 8mm = 3g FC FIBTEM A5 9 - 10mm = 2g FC

Other interventions: Cryoprecipitate
Fibrinogen replacement using Cryoprecipitate as per ROTEM guided treatment algorithm [FIBTEM A5 = 10mm]
FIBTEM A5 0mm (Flat Line) = 20 Units Cryo FIBTEM A5 1- 4mm = 16 Units Cryo FIBTEM A5 5 - 6mm = 14 Units Cryo FIBTEM A5 7 - 8mm = 10 Units Cryo FIBTEM A5 9 - 10mm = 8 Units Cryo

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
Time to administration of Fibrinogen Replacement from time of ROTEM analysis indicating fibrinogen supplementation is required First dose of Fibrinogen Concentrate or Cryoprecipitate required - It is anticipated that fibrinogen replacement will occur with 3 hours Fibrinogen replacement will be with either FC or Cryroprecipitate depending on randomisation
Timepoint [1] 0 0
3 Hours
Primary outcome [2] 0 0
Feasibility of administering FC within 30 mins of clinical scenario and ROTEM analysis suggesting Fibrinogen replacement is required - Proportion of patients receiving FC within 30 minutes
Timepoint [2] 0 0
3 Hours
Primary outcome [3] 0 0
Effects on Fibrinogen levels during traumatic haemorrhage as measured by Clauss Fibrinogen - Blood sampling will occur for 7 days after admission/randomisation
Timepoint [3] 0 0
7 Days
Primary outcome [4] 0 0
Effects on Fibrinogen levels during traumatic haemorrhage as measured by FIBTEM - Blood sampling will occur for 7 days after admission/randomisation
Timepoint [4] 0 0
7 Days
Secondary outcome [1] 0 0
Transfusion Requirements - In number of units of Packed Red Blood Cells, Plasma, FC, Cryoprecipitate, Platelets, Prothrombin Complex Concentrate at 4, 6, 24, 48hrs
Timepoint [1] 0 0
48 hours
Secondary outcome [2] 0 0
Duration of bleeding episode or time until surgical control - It is anticipated that haemorrhage control will be achieved within 12 hours
Timepoint [2] 0 0
12 hours
Secondary outcome [3] 0 0
Intensive Care Unit Length of stay
Timepoint [3] 0 0
1 Year
Secondary outcome [4] 0 0
Hospital Length of Stay
Timepoint [4] 0 0
1 Year
Secondary outcome [5] 0 0
Adverse Events - Transfusion related adverse events Sepsis Multiple Organ Failure Acute Renal Failure Thromboembolic Complications
Timepoint [5] 0 0
1Year
Secondary outcome [6] 0 0
All cause Mortality - Mortality at 4, 6, 24 hours and up to 90 days
Timepoint [6] 0 0
90 Days

Eligibility
Key inclusion criteria
1. Adult affected by Trauma (>18yrs) and

2. Judged to have significant haemorrhage or

3. Predicted to require significant transfusion with ABC Score = 2 or by treating
clinician judgement
Minimum age
18 Years
Maximum age
100 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Injury judged incompatible with survival

2. Pregnancy

3. Known objection to blood products

4. Previous Fibrinogen replacement this admission

5. Pre-Trauma Centre fibrinogen replacement

6. Participation in 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [2] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [3] 0 0
Gold Coast University Hospital - Gold Coast
Recruitment hospital [4] 0 0
Townsville Hospital - Townsville
Recruitment postcode(s) [1] 0 0
4029 - Brisbane
Recruitment postcode(s) [2] 0 0
4102 - Brisbane
Recruitment postcode(s) [3] 0 0
4215 - Gold Coast
Recruitment postcode(s) [4] 0 0
4814 - Townsville

Funding & Sponsors
Primary sponsor type
Other
Name
Gold Coast Hospital and Health Service
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Emergency Medicine Foundation
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
National Blood Authority
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Australian Red Cross
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
- Haemorrhage in severe trauma is a significant cause of mortality and is potentially the
most preventable cause of death in trauma patients

- Trauma Induced Coagulopathy (TIC) is a complex coagulopathy associated with severe
trauma

- Hypo/dysfibrinogenaemia plays an important role in TIC

- Early replacement of fibrinogen may improve outcomes

- Fibrinogen replacement is potentially inadequate in standard fixed ratio Major
Haemorrhage Protocols (MHP) utilising Plasma and/or Cryoprecipitate

- The majority of centres utilise cryoprecipitate for additional fibrinogen
supplementation as part of a MHP

- Cryoprecipitate administration is often delayed (between 60 - 120 minutes) in a fixed
ratio MHP

- It is clear early intervention in severe traumatic haemorrhage is associated with
improved outcomes - CRASH 2 and PROPPR studies

- Increasing interest in the use of Fibrinogen Concentrate (FC) in severe bleeding but not
supported by high level evidence

- Benefits of FC - viral inactivation, known dose, easily reconstituted, can be
administered quickly in high dose and stored at room temperature in the trauma
resuscitation bay

- No previous studies comparing FC and Cryoprecipitate in bleeding trauma patients

- Fibrinogen supplementation will be guided by an accepted ROTEM targeted treatment
algorithm

- It will be a pilot, multi-centre randomised controlled trial comparing FC to
Cryoprecipitate (current standard practise in fibrinogen supplementation)

- Hypothesis: Fibrinogen replacement in severe traumatic haemorrhage can be achieved
quicker with a more predictable dose response using Fibrinogen Concentrate compared to
Cryoprecipitate

- It is imperative that robust and clinically relevant trials are performed to investigate
fibrinogen supplementation in trauma before widespread adoption makes performing such
studies unfeasible
Trial website
https://clinicaltrials.gov/show/NCT02745041
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
James Winearls, MBBS
Address 0 0
Gold Coast University Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications