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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05449834
Registration number
NCT05449834
Ethics application status
Date submitted
5/07/2022
Date registered
8/07/2022
Titles & IDs
Public title
Fibrinogen Early In Severe Trauma StudY II
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Scientific title
Fibrinogen Early In Severe Trauma StudY II
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Secondary ID [1]
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ANZIC-RC/ZM001
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Universal Trial Number (UTN)
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Trial acronym
FEISTY II
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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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Haemorrhagic Shock
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Coagulopathy
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Condition category
Condition code
Blood
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Other blood disorders
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Skin
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Fibrinogen Concentrate
Other interventions - Cryoprecipitate
Experimental: Fibrinogen Concentrate (FC) - Fibrinogen Replacement using 3g Fibrinogen Concentrate as per:
ROTEM FIBTEM A5 = 10mm or TEG FF A10 = 15mm or FibC = 2g/L
Active comparator: Cryoprecipitate (Cryo) - Fibrinogen Replacement using 10 Units WB or 4U Apheresis Cryo (Australia) as per:
ROTEM FIBTEM A5 = 10mm or TEG FF A10 = 15mm or FibC = 2g/L
Treatment: Drugs: Fibrinogen Concentrate
3g Fibrinogen Concentrate
Other interventions: Cryoprecipitate
10U WB or 4U Apheresis Cryoprecipitate
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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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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Days Alive and Out of Hospital at 90 Days
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Assessment method [1]
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DAOH 90
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Timepoint [1]
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90 Days
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Secondary outcome [1]
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Number RBC Units at 24 hours
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Assessment method [1]
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Red Blood Cells
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Timepoint [1]
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24 hours
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Secondary outcome [2]
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All cause mortality at 90 days
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Assessment method [2]
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Mortality at Day 90
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Timepoint [2]
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90 days
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Secondary outcome [3]
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All cause mortality at 6 and 24 hours
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Assessment method [3]
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Mortality at 6 and 24 hours
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Timepoint [3]
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24 hours
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Secondary outcome [4]
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Death from haemorrhage at 6 and 24 hours
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Assessment method [4]
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Haemorrhage as cause of death at 6 and 24 hours
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Timepoint [4]
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24 hours
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Secondary outcome [5]
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Ventilator free days up to day 28
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Assessment method [5]
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VFD 28 days
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Timepoint [5]
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28 days
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Secondary outcome [6]
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Symptomatic thromboembolic events to 28 days
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Assessment method [6]
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Venous and Arterial Thrombotic events
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Timepoint [6]
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28 days
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Secondary outcome [7]
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Quality of life at 3, 6 and 12 months
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Assessment method [7]
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EQ5D-5L European Quality of Life 5 Dimensions 5 Levels Scored 0-100, where 0 = Worst QOL and 100 = Best QOL
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Timepoint [7]
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12 Months
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Secondary outcome [8]
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Health and disability at 3, 6 and 12 months
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Assessment method [8]
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WHODAS 2.0 World Health Organisation Disability and Assessment Schedule 2.0 Scored 0-100, where 0 = No Disability and 100 = Full Disbility
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Timepoint [8]
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12 months
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Secondary outcome [9]
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Functional outcome (Patients with TBI) at 12 months
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Assessment method [9]
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GOSE Glasgow Outcome Scale Extended Scored 1-8, where 1 = Death and 8 = Upper Good Recovery
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Timepoint [9]
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12 months
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Secondary outcome [10]
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Organ failure assessment
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Assessment method [10]
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Denver MOF Score Denver Multiple Organ Failure Score Scored 0-12, where 0 = No Organ Failure and 12 = Severe MOF
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Timepoint [10]
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28 days
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Eligibility
Key inclusion criteria
1. Adult affected by trauma (=18yrs)
2. Judged to have active haemorrhage by treating clinician
3. Activation of local MHP and/or Transfusion of Emergency Blood Products
4. FIBTEM A5 = 10mm or TEG FF A5 = 15mm or FibC = 2 g/l
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Minimum age
18
Years
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Maximum age
100
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 presentation to hospital
3. Known pregnancy
4. Known genetic or drug induced coagulation disorder
5. Known objection to blood products
6. Dedicated prior fibrinogen replacement
7. Participation in a 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 receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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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
21/11/2022
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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
1/12/2026
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Actual
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Sample size
Target
850
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD,SA
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Recruitment hospital [1]
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Gold Coast University Hospital - Gold Coast
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Recruitment hospital [2]
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Royal Adelaide Hospital - Adelaide
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Recruitment postcode(s) [1]
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4215 - Gold Coast
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Recruitment postcode(s) [2]
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5000 - Adelaide
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Funding & Sponsors
Primary sponsor type
Other
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Name
Australian and New Zealand Intensive Care Research Centre
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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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Blood Synergy Program
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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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Australian and New Zealand Intensive Care Society Clinical Trials Group
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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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Australasian College for Emergency Medicine
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Address [3]
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Country [3]
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Other collaborator category [4]
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Other
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Name [4]
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Australian Red Cross Lifeblood
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Address [4]
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Country [4]
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Other collaborator category [5]
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Other
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Name [5]
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Australasian Trauma Society
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Address [5]
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Country [5]
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Ethics approval
Ethics application status
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Summary
Brief summary
Annually over 7000 Australians are treated for severe trauma. Haemorrhage secondary to severe trauma is a major cause of potentially preventable death and poor outcomes in Australian adults. Severe trauma may trigger changes in blood clotting mechanisms and factor levels leading to inhibition of clot formation and reduced clot strength. This results in the inability of the severely injured trauma patient to form adequate clots to help stop bleeding. There is good evidence to suggest the loss of clotting factors during haemorrhage is associated with worse outcomes and it is thought the early replacement of these factors may reduce bleeding and improve patient outcomes. Fibrinogen is a key clotting factor that helps bind clots together and early fibrinogen replacement may improve outcomes. Currently fibrinogen is replaced using cryoprecipitate, a blood product made from blood donated by healthy donors which is a precious resource. It can take a significant amount of time to administer as it is frozen and stored in the blood bank. Timely administration of cryoprecipitate is difficult as it requires thawing prior to transfusion. The large doses of cryoprecipitate used in traumatic haemorrhage can put strain on local blood banks in supplying requested units in a timely manner. Additionally, the widely dispersed population of Australia introduces logistic challenges to the maintenance of adequate cryoprecipitate stocks to individual hospital blood banks, especially in remote regions. However, cryoprecipitate contains a number of other coagulation factors (not just fibrinogen) that may be instrumental in clot formation and resistance to fibrinolysis. Fibrinogen concentrate is an alternative product used to assist in blood clotting. It is a dry powder form of fibrinogen and can be reconstituted at the bedside and given quickly. The use of a fibrinogen factor concentrate with a long shelf life that is easy to use has significant implications for both large urban metropolitan areas and remote isolated communities. The timing and mode of fibrinogen replacement in traumatic haemorrhage has implications for patient outcomes, blood product availability, costs and the national blood supply. Despite the importance of fibrinogen replacement in traumatic haemorrhage, there have been no clinical trials powered for clinical outcomes directly comparing fibrinogen concentrate and cryoprecipitate. FEISTY II will evaluate the efficacy, safety and cost-effectiveness of Fibrinogen Concentrate vs Cryoprecipitate in trauma patients with major haemorrhage. FEISTY II is a phase III randomised trial which will enrol 850 patients from Australian and New Zealand major trauma centres, with a primary patient outcome of days alive out of hospital at day 90 after injury. Severely injured trauma patients who require blood transfusion and have evidence of low fibrinogen levels will be randomised to receive either fibrinogen concentrate or standard care with cryoprecipitate
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Trial website
https://clinicaltrials.gov/study/NCT05449834
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Zoe McQuilten, MBBS
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Address
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Monash University
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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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+61399030379
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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
No current plan to make IPD available
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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/NCT05449834