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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/NCT03508141




Registration number
NCT03508141
Ethics application status
Date submitted
23/03/2018
Date registered
25/04/2018
Date last updated
29/06/2020

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

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

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

Experimental: Fibrinogen Concentrate - Fibrinogen Replacement using Fibrinogen Concentrate as per ROTEM (FIBTEM) FIBTEM A5 0mm = 60mg/kg FC FIBTEM A5 1-4mm = 50mg/kg FC FIBTEM A5 5-6mm = 40mg/kg FC FIBTEM A5 7-8mm = 30mg/kg FC FIBTEM A5 9-10mm = 20mg/kg FC

Active Comparator: Cryoprecipitate - Fibrinogen Replacement using Cryoprecipitate as per ROTEM (FIBTEM) FIBTEM A5 0mm = 6ml/kg Cryoprecipitate FIBTEM A5 1-4mm = 5ml/kg Cryoprecipitate FIBTEM A5 5-6mm = 4ml/kg Cryoprecipitate FIBTEM A5 7-8mm = 3ml/kg Cryoprecipitate FIBTEM A5 9-10mm = 2ml/kg Cryoprecipitate


Treatment: Drugs: Fibrinogen Concentrate
Experimental

Treatment: Drugs: Cryoprecipitate
Comparator
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to administration of fibrinogen replacement from time of identification of hypofibrinogenaemia requiring fibrinogen replacement
Timepoint [1] 0 0
3 Hours
Secondary outcome [1] 0 0
Transfusion Requirements
Timepoint [1] 0 0
Up to 48 hours after Trauma Unit presentation
Secondary outcome [2] 0 0
Duration of bleeding episode or time until surgical control
Timepoint [2] 0 0
It is anticipated that haemorrhage control will be achieved within 12 hours
Secondary outcome [3] 0 0
Intensive Care Unit LOS
Timepoint [3] 0 0
1 Year
Secondary outcome [4] 0 0
Hospital LOS
Timepoint [4] 0 0
1 Year
Secondary outcome [5] 0 0
Adverse Events
Timepoint [5] 0 0
1 Year
Secondary outcome [6] 0 0
All Cause Mortality
Timepoint [6] 0 0
Up to 90 Days
Secondary outcome [7] 0 0
Functional Outcomes GOS-E Paediatrics
Timepoint [7] 0 0
Up to 90 Days

Eligibility
Key inclusion criteria
1. Child affected by trauma (3 months to 18 years)

2. Judged to have significant haemorrhage OR predicted to require significant transfusion
by the treating clinician

3. Activation of Local MHP or transfusion of emergency red blood cells (Pre-hospital or
at Trauma Centre)
Minimum age
3 Months
Maximum age
18 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 hospital admission

3. Pregnancy

4. Known personal or parental objection to blood products

5. Known coagulation disorder (i.e. haemophilia, von Willebrand disease)

6. Previous dedicated fibrinogen replacement this admission

7. Pre-Trauma Centre dedicated fibrinogen replacement

8. 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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2021
Actual
Sample size
Target
44
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
Recruitment hospital [1] 0 0
Westmead Childrens Hospital - Sydney
Recruitment hospital [2] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [3] 0 0
Lady Cilento Children's Hospital - Brisbane
Recruitment hospital [4] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [5] 0 0
Cairns Hospital - Cairns
Recruitment hospital [6] 0 0
Gold Coast University Hospital - Gold Coast
Recruitment hospital [7] 0 0
Mackay Base Hospital - Mackay
Recruitment hospital [8] 0 0
Rockhampton Hospital - Rockhampton
Recruitment hospital [9] 0 0
Townsville Hospital - Townsville
Recruitment hospital [10] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
4029 - Brisbane
Recruitment postcode(s) [3] 0 0
4101 - Brisbane
Recruitment postcode(s) [4] 0 0
4102 - Brisbane
Recruitment postcode(s) [5] 0 0
4211 - Cairns
Recruitment postcode(s) [6] 0 0
4215 - Gold Coast
Recruitment postcode(s) [7] 0 0
4211 - Mackay
Recruitment postcode(s) [8] 0 0
4211 - Rockhampton
Recruitment postcode(s) [9] 0 0
4814 - Townsville
Recruitment postcode(s) [10] 0 0
- Adelaide

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
1. Haemorrhage in severe trauma is a significant cause of mortality and is potentially the
most preventable cause of death in paediatric trauma patients

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

3. Hypo/dysfibrinogenaemia plays an important role in TIC

4. Early replacement of fibrinogen may improve outcomes

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

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

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

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

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

10. 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

12. No previous studies comparing FC and Cryoprecipitate in bleeding paediatric trauma
patients 13. Fibrinogen supplementation will be guided by an accepted ROTEM targeted
treatment algorithm 14. Pilot, multi-centre randomised controlled trial comparing FC to
Cryoprecipitate (current standard practise in fibrinogen supplementation) 15. Hypothesis:
Fibrinogen replacement in severe traumatic haemorrhage can be achieved quicker with a more
predictable dose response using Fibrinogen Concentrate compared to Cryoprecipitate 16. It is
imperative that robust and clinically relevant trials are performed to investigate fibrinogen
supplementation in paediatric trauma patients before widespread adoption makes performing
such studies unfeasible
Trial website
https://clinicaltrials.gov/ct2/show/NCT03508141
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Shane George, MBBS
Address 0 0
Lady Cilento Children's Hospital
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
+61756875684
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/NCT03508141