Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
44 participants
INTERVENTIONAL
2018-07-01
2021-06-30
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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
Fibrinogen Concentrate
Experimental
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
Cryoprecipitate
Comparator
Interventions
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Fibrinogen Concentrate
Experimental
Cryoprecipitate
Comparator
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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)
Exclusion Criteria
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
3 Months
18 Years
ALL
No
Sponsors
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Emergency Medicine Foundation
OTHER
National Blood Authority
OTHER
Australian Red Cross
OTHER
Gold Coast Hospital and Health Service
OTHER_GOV
Responsible Party
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Dr James Winearls, BSc (Hons), MBBS, MRCP, FCICM
Dr James Winearls, Consultant Intensivist GCUH
Principal Investigators
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Shane George, MBBS
Role: PRINCIPAL_INVESTIGATOR
Lady Cilento Children's Hospital
Locations
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Westmead Childrens Hospital
Sydney, New South Wales, Australia
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
Lady Cilento Children's Hospital
Brisbane, Queensland, Australia
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Cairns Hospital
Cairns, Queensland, Australia
Gold Coast University Hospital
Gold Coast, Queensland, Australia
Mackay Base Hospital
Mackay, Queensland, Australia
Rockhampton Hospital
Rockhampton, Queensland, Australia
Townsville Hospital
Townsville, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Countries
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Central Contacts
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Facility Contacts
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Cath Hurn, MBBS
Role: primary
Dr George, MBBS
Role: primary
Glenn Ryan, MBBS
Role: primary
Melita Trout, MBBS
Role: primary
References
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George S, Wake E, Jansen M, Roy J, Maconachie S, Paasilahti A, Wiseman G, Gibbons K, Winearls J; FEISTY Investigators. Fibrinogen Early In Severe paediatric Trauma studY (FEISTY junior): protocol for a randomised controlled trial. BMJ Open. 2022 May 4;12(5):e057780. doi: 10.1136/bmjopen-2021-057780.
Other Identifiers
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FEISTY Jnr 1
Identifier Type: -
Identifier Source: org_study_id
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