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Fibrinogen Early In Severe Trauma studY Junior (FEISTY Jnr)

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ClinicalTrials.gov Identifier: NCT03508141
Recruitment Status : Recruiting
First Posted : April 25, 2018
Last Update Posted : June 29, 2020
Sponsor:
Collaborators:
Emergency Medicine Foundation
National Blood Authority
Australian Red Cross
Information provided by (Responsible Party):
Dr James Winearls, BSc (Hons), MBBS, MRCP, FCICM, Gold Coast Hospital and Health Service

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


Condition or disease Intervention/treatment Phase
Trauma Hemorrhage Coagulopathy Pediatrics Drug: Fibrinogen Concentrate Drug: Cryoprecipitate Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Fibrinogen Concentrate vs Cryoprecipitate in Traumatic Haemorrhage in Children: A Pilot Randomised Controlled Trial
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
Drug Information available for: Fibrinogen

Arm Intervention/treatment
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
Drug: Fibrinogen Concentrate
Experimental
Other Name: Riastap

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
Drug: Cryoprecipitate
Comparator




Primary Outcome Measures :
  1. Time to administration of fibrinogen replacement from time of identification of hypofibrinogenaemia requiring fibrinogen replacement [ Time Frame: 3 Hours ]
    Time to fibrinogen replacement


Secondary Outcome Measures :
  1. Transfusion Requirements [ Time Frame: Up to 48 hours after Trauma Unit presentation ]
    In number of units of Packed Red Blood Cells, Plasma, FC, Cryoprecipitate, Platelets, Prothrombin Complex Concentrate at 4, 6, 24, 48hrs

  2. Duration of bleeding episode or time until surgical control [ Time Frame: It is anticipated that haemorrhage control will be achieved within 12 hours ]
    Duration bleeding episode

  3. Intensive Care Unit LOS [ Time Frame: 1 Year ]
    ICU LOS

  4. Hospital LOS [ Time Frame: 1 Year ]
    Hospital LOS

  5. Adverse Events [ Time Frame: 1 Year ]
    Transfusion related adverse events, Sepsis, Multiple Organ Failure, Acute Renal Failure, Symptomatic Thromboembolic Complications

  6. All Cause Mortality [ Time Frame: Up to 90 Days ]
    Mortality at 4, 6, 24 hours and up to 90 days

  7. Functional Outcomes GOS-E Paediatrics [ Time Frame: Up to 90 Days ]
    Functional Outcome Measures at 60 and 90 Days



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Ages Eligible for Study:   3 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03508141


Contacts
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Contact: James Winearls, MBBS +61756875684 james.winearls@health.qld.gov.au
Contact: Elizabeth Wake, BN +61756874149 elizabeth.wake@health.qld.gov.au

Locations
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Australia, New South Wales
Westmead Childrens Hospital Recruiting
Sydney, New South Wales, Australia
Contact: Melanie Jansen       melanie.jansen@health.nsw.gov.au   
Principal Investigator: Melanie Jansen         
Australia, Queensland
Royal Brisbane and Women's Hospital Recruiting
Brisbane, Queensland, Australia, 4029
Contact: Cath Hurn, MBBS         
Lady Cilento Children's Hospital Recruiting
Brisbane, Queensland, Australia, 4101
Contact: Dr George, MBBS         
Princess Alexandra Hospital Recruiting
Brisbane, Queensland, Australia, 4102
Contact: Glenn Ryan, MBBS         
Cairns Hospital Recruiting
Cairns, Queensland, Australia, 4211
Contact: Cath Tacon, FCICM       cath.tacon@health.qld.gov.au   
Principal Investigator: Cath Tacon, FCICM         
Gold Coast University Hospital Recruiting
Gold Coast, Queensland, Australia, 4215
Contact: James Winearls, MBBS       james.winearls@health.qld.gov.au   
Mackay Base Hospital Recruiting
Mackay, Queensland, Australia, 4211
Contact: Anni Paasilahti, FCICM       anni.paasilahti@health.qld.gov.au   
Principal Investigator: Anni Paasilahti, FCICM         
Rockhampton Hospital Recruiting
Rockhampton, Queensland, Australia, 4211
Contact: Helen Miles, MBBS       helen.miles@health.qld.gov.au   
Principal Investigator: Helen Miles, MBBS         
Townsville Hospital Recruiting
Townsville, Queensland, Australia, 4814
Contact: Melita Trout, MBBS         
Australia, South Australia
Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia
Contact: Daniel Ellis, MBBS, FACEM, FCICM, FIMC       dan.ellis@sa.gov.au   
Principal Investigator: Dan Ellis, MBBS, FACEM, FCICM, FIMC         
Sponsors and Collaborators
Gold Coast Hospital and Health Service
Emergency Medicine Foundation
National Blood Authority
Australian Red Cross
Investigators
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Principal Investigator: Shane George, MBBS Lady Cilento Children's Hospital
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Responsible Party: Dr James Winearls, BSc (Hons), MBBS, MRCP, FCICM, Dr James Winearls, Consultant Intensivist GCUH, Gold Coast Hospital and Health Service
ClinicalTrials.gov Identifier: NCT03508141    
Other Study ID Numbers: FEISTY Jnr 1
First Posted: April 25, 2018    Key Record Dates
Last Update Posted: June 29, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr James Winearls, BSc (Hons), MBBS, MRCP, FCICM, Gold Coast Hospital and Health Service:
Fibrinogen Concentrate
Cryoprecipitate
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes