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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03508141
Registration number
NCT03508141
Ethics application status
Date submitted
23/03/2018
Date registered
25/04/2018
Titles & IDs
Public title
Fibrinogen Early In Severe Trauma studY Junior
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Scientific title
Fibrinogen Concentrate vs Cryoprecipitate in Traumatic Haemorrhage in Children: A Pilot Randomised Controlled Trial
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Secondary ID [1]
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FEISTY Jnr 1
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Universal Trial Number (UTN)
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Trial acronym
FEISTY Jnr
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Trauma
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Hemorrhage
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Coagulopathy
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Pediatrics
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to administration of fibrinogen replacement from time of identification of hypofibrinogenaemia requiring fibrinogen replacement
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Assessment method [1]
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Time to fibrinogen replacement
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Timepoint [1]
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3 Hours
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Secondary outcome [1]
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Transfusion Requirements
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Assessment method [1]
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In number of units of Packed Red Blood Cells, Plasma, FC, Cryoprecipitate, Platelets, Prothrombin Complex Concentrate at 4, 6, 24, 48hrs
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Timepoint [1]
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Up to 48 hours after Trauma Unit presentation
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Secondary outcome [2]
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Duration of bleeding episode or time until surgical control
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Assessment method [2]
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Duration bleeding episode
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Timepoint [2]
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It is anticipated that haemorrhage control will be achieved within 12 hours
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Secondary outcome [3]
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Intensive Care Unit LOS
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Assessment method [3]
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ICU LOS
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Timepoint [3]
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1 Year
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Secondary outcome [4]
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Hospital LOS
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Assessment method [4]
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Hospital LOS
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Timepoint [4]
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1 Year
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Secondary outcome [5]
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Adverse Events
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Assessment method [5]
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Transfusion related adverse events, Sepsis, Multiple Organ Failure, Acute Renal Failure, Symptomatic Thromboembolic Complications
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Timepoint [5]
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1 Year
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Secondary outcome [6]
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All Cause Mortality
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Assessment method [6]
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Mortality at 4, 6, 24 hours and up to 90 days
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Timepoint [6]
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Up to 90 Days
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Secondary outcome [7]
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Functional Outcomes GOS-E Paediatrics
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Assessment method [7]
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Functional Outcome Measures at 60 and 90 Days
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Timepoint [7]
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Up to 90 Days
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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)
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Minimum age
3
Months
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Maximum age
18
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
UNKNOWN
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/06/2021
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Actual
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Sample size
Target
44
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
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Recruitment hospital [1]
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Westmead Childrens Hospital - Sydney
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Recruitment hospital [2]
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Royal Brisbane and Women's Hospital - Brisbane
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Recruitment hospital [3]
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Lady Cilento Children's Hospital - Brisbane
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Recruitment hospital [4]
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Princess Alexandra Hospital - Brisbane
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Recruitment hospital [5]
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Cairns Hospital - Cairns
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Recruitment hospital [6]
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Gold Coast University Hospital - Gold Coast
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Recruitment hospital [7]
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Mackay Base Hospital - Mackay
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Recruitment hospital [8]
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Rockhampton Hospital - Rockhampton
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Recruitment hospital [9]
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Townsville Hospital - Townsville
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Recruitment hospital [10]
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Royal Adelaide Hospital - Adelaide
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Recruitment postcode(s) [1]
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- Sydney
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Recruitment postcode(s) [2]
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4029 - Brisbane
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Recruitment postcode(s) [3]
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4101 - Brisbane
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Recruitment postcode(s) [4]
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4102 - Brisbane
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Recruitment postcode(s) [5]
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4211 - Cairns
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Recruitment postcode(s) [6]
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4215 - Gold Coast
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Recruitment postcode(s) [7]
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4211 - Mackay
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Recruitment postcode(s) [8]
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4211 - Rockhampton
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Recruitment postcode(s) [9]
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4814 - Townsville
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Recruitment postcode(s) [10]
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- Adelaide
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Funding & Sponsors
Primary sponsor type
Government body
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Name
Gold Coast Hospital and Health Service
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Emergency Medicine Foundation
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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National Blood Authority
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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Australian Red Cross
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Address [3]
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Country [3]
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Ethics approval
Ethics application status
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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
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Trial website
https://clinicaltrials.gov/study/NCT03508141
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Trial related presentations / publications
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.
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Public notes
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Contacts
Principal investigator
Name
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Shane George, MBBS
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Address
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Lady Cilento Children's Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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James Winearls, MBBS
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Address
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Country
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Phone
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+61756875684
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03508141