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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02745041
Registration number
NCT02745041
Ethics application status
Date submitted
5/04/2016
Date registered
20/04/2016
Titles & IDs
Public title
Fibrinogen Early In Severe Trauma studY
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Scientific title
Fibrinogen Concentrate vs Cryoprecipitate in Traumatic Haemorrhage: A Pilot Randomised Controlled Trial
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Secondary ID [1]
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FEISTY-1
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Universal Trial Number (UTN)
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Trial acronym
FEISTY
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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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Haemorrhage
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Coagulopathy
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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
Other interventions - Cryoprecipitate
Experimental: Fibrinogen Concentrate - Fibrinogen Replacement using Fibrinogen Concentrate as per ROTEM guided treatment algorithm \[FIBTEM = A5 10mm\]
Active comparator: Cryoprecipitate - Fibrinogen replacement using Cryoprecipitate as per ROTEM guided treatment algorithm \[FIBTEM A5 = 10mm\]
Treatment: Drugs: Fibrinogen Concentrate
Fibrinogen Replacement using Fibrinogen Concentrate as per ROTEM guided treatment algorithm \[FIBTEM = A5 10mm\]
FIBTEM A5 0mm (Flat Line) = 6g FC FIBTEM A5 1 - 4mm = 5g FC FIBTEM A5 5 - 6mm = 4g FC FIBTEM A5 7 - 8mm = 3g FC FIBTEM A5 9 - 10mm = 2g FC
Other interventions: Cryoprecipitate
Fibrinogen replacement using Cryoprecipitate as per ROTEM guided treatment algorithm \[FIBTEM A5 = 10mm\]
FIBTEM A5 0mm (Flat Line) = 20 Units Cryo FIBTEM A5 1- 4mm = 16 Units Cryo FIBTEM A5 5 - 6mm = 14 Units Cryo FIBTEM A5 7 - 8mm = 10 Units Cryo FIBTEM A5 9 - 10mm = 8 Units Cryo
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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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Time to administration of Fibrinogen Replacement from time of ROTEM analysis indicating fibrinogen supplementation is required First dose of Fibrinogen Concentrate or Cryoprecipitate required
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Assessment method [1]
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It is anticipated that fibrinogen replacement will occur with 3 hours Fibrinogen replacement will be with either FC or Cryroprecipitate depending on randomisation
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Timepoint [1]
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3 Hours
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Primary outcome [2]
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Feasibility of administering FC within 30 mins of clinical scenario and ROTEM analysis suggesting Fibrinogen replacement is required
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Assessment method [2]
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Proportion of patients receiving FC within 30 minutes
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Timepoint [2]
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3 Hours
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Primary outcome [3]
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Effects on Fibrinogen levels during traumatic haemorrhage as measured by Clauss Fibrinogen
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Assessment method [3]
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Blood sampling will occur for 7 days after admission/randomisation
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Timepoint [3]
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7 Days
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Primary outcome [4]
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Effects on Fibrinogen levels during traumatic haemorrhage as measured by FIBTEM
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Assessment method [4]
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Blood sampling will occur for 7 days after admission/randomisation
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Timepoint [4]
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7 Days
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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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48 hours
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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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It is anticipated that haemorrhage control will be achieved within 12 hours
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Timepoint [2]
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12 hours
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Secondary outcome [3]
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Intensive Care Unit Length of stay
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Assessment method [3]
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Timepoint [3]
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1 Year
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Secondary outcome [4]
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Hospital Length of Stay
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Assessment method [4]
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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 Thromboembolic Complications
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Timepoint [5]
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1Year
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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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90 Days
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Eligibility
Key inclusion criteria
1. Adult affected by Trauma (>18yrs) and
2. Judged to have significant haemorrhage or
3. Predicted to require significant transfusion with ABC Score = 2 or by treating clinician judgement
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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. Pregnancy
3. Known objection to blood products
4. Previous Fibrinogen replacement this admission
5. Pre-Trauma Centre fibrinogen replacement
6. 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
Open (masking not used)
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Who is / are masked / blinded?
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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
Completed
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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
1/12/2016
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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
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Actual
20/02/2018
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Sample size
Target
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Accrual to date
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Final
100
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Royal Brisbane and Women's Hospital - Brisbane
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Recruitment hospital [2]
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Princess Alexandra Hospital - Brisbane
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Recruitment hospital [3]
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Gold Coast University Hospital - Gold Coast
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Recruitment hospital [4]
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Townsville Hospital - Townsville
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Recruitment postcode(s) [1]
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4029 - Brisbane
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Recruitment postcode(s) [2]
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4102 - Brisbane
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Recruitment postcode(s) [3]
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4215 - Gold Coast
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Recruitment postcode(s) [4]
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4814 - Townsville
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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
* Haemorrhage in severe trauma is a significant cause of mortality and is potentially the most preventable cause of death in trauma patients * Trauma Induced Coagulopathy (TIC) is a complex coagulopathy associated with severe trauma * Hypo/dysfibrinogenaemia plays an important role in TIC * Early replacement of fibrinogen may improve outcomes * Fibrinogen replacement is potentially inadequate in standard fixed ratio Major Haemorrhage Protocols (MHP) utilising Plasma and/or Cryoprecipitate * The majority of centres utilise cryoprecipitate for additional fibrinogen supplementation as part of a MHP * Cryoprecipitate administration is often delayed (between 60 - 120 minutes) in a fixed ratio MHP * It is clear early intervention in severe traumatic haemorrhage is associated with improved outcomes - CRASH 2 and PROPPR studies * Increasing interest in the use of Fibrinogen Concentrate (FC) in severe bleeding but not supported by high level evidence * 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 * No previous studies comparing FC and Cryoprecipitate in bleeding trauma patients * Fibrinogen supplementation will be guided by an accepted ROTEM targeted treatment algorithm * It will be a pilot, multi-centre randomised controlled trial comparing FC to Cryoprecipitate (current standard practise in fibrinogen supplementation) * Hypothesis: Fibrinogen replacement in severe traumatic haemorrhage can be achieved quicker with a more predictable dose response using Fibrinogen Concentrate compared to Cryoprecipitate * It is imperative that robust and clinically relevant trials are performed to investigate fibrinogen supplementation in trauma before widespread adoption makes performing such studies unfeasible
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Trial website
https://clinicaltrials.gov/study/NCT02745041
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Trial related presentations / publications
Morrow GB, Feller T, McQuilten Z, Wake E, Ariens RAS, Winearls J, Mutch NJ, Laffan MA, Curry N. Cryoprecipitate transfusion in trauma patients attenuates hyperfibrinolysis and restores normal clot structure and stability: Results from a laboratory sub-study of the FEISTY trial. Crit Care. 2022 Sep 26;26(1):290. doi: 10.1186/s13054-022-04167-x. Winearls J, Wullschleger M, Wake E, Hurn C, Furyk J, Ryan G, Trout M, Walsham J, Holley A, Cohen J, Shuttleworth M, Dyer W, Keijzers G, Fraser JF, Presneill J, Campbell D. Fibrinogen Early In Severe Trauma studY (FEISTY): study protocol for a randomised controlled trial. Trials. 2017 May 26;18(1):241. doi: 10.1186/s13063-017-1980-x.
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Public notes
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Contacts
Principal investigator
Name
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James Winearls, MBBS
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Address
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Gold Coast University 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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Address
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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 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/NCT02745041