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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05855252
Registration number
NCT05855252
Ethics application status
Date submitted
28/03/2023
Date registered
11/05/2023
Titles & IDs
Public title
PRECISION-TBI - An Observational Study of Patients With Moderate to Severe Traumatic Brain Injury
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Scientific title
PRECISION-TBI - A Multi-centre Prospective Observational Cohort Study of Patients With Moderate to Severe Traumatic Brain Injury
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Secondary ID [1]
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ANZIC-RC/AU001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Trauma, Brain
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Condition category
Condition code
Injuries and Accidents
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Other injuries and accidents
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Other interventions - No intervention
Other interventions: No intervention
No intervention
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Intervention code [1]
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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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Glasgow outcome scale
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Assessment method [1]
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Unfavourable outcome at 6 months post-injury (defined as a score of 4 or less on the 8-point extended Glasgow outcome scale)
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Timepoint [1]
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At 6 months post-injury
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Secondary outcome [1]
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Mortality
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Assessment method [1]
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Death occurring any time between date of hospital admission and 6 months post-injury (up to 180 days post-injury)
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Timepoint [1]
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Up to 6 months post-injury
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Secondary outcome [2]
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Hospital length of stay
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Assessment method [2]
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Number of acute hospital admission days
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Timepoint [2]
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Through study completion, an average of 1 year
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Secondary outcome [3]
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Intensive care Unit (ICU) length of stay
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Assessment method [3]
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Number of ICU admission days
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Timepoint [3]
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Through study completion, an average of 1 year
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Secondary outcome [4]
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EuroQol (EQ-5D five-level)
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Assessment method [4]
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Quality of life questionnaire, each of the 5 questions is scored from 1 (no problem performing that particular task) to 5 (unable to perform the task).
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Timepoint [4]
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At 6 months post-injury
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Eligibility
Key inclusion criteria
* Age =18 years
* Clinical diagnosis of moderate to severe TBI
* Insertion of invasive intra-cranial monitoring
* Study inclusion within 48 hours of ICU admission
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Minimum age
18
Years
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Maximum age
No limit
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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
* Admission to the ICU is solely for the purposes of palliative care or confirmation of organ donation
* Advanced care directive or previously stated wish not to be included in research activities
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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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
14/08/2022
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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
1/07/2025
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Actual
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Sample size
Target
300
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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,VIC
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Recruitment hospital [1]
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St George Hospital - Kogarah
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Recruitment hospital [2]
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John Hunter Hospital - New Lambton Heights
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Recruitment hospital [3]
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Royal North Shore Hospital - St Leonards
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Recruitment hospital [4]
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Westmead Hospital - Westmead
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Recruitment hospital [5]
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Royal Brisbane and Women's Hospital - Herston
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Recruitment hospital [6]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [7]
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Flinders Medical Centre - Bedford Park
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Recruitment hospital [8]
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The Alfred Hospital - Melbourne
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Recruitment hospital [9]
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Royal Melbourne Hospital - Melbourne
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Recruitment postcode(s) [1]
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2217 - Kogarah
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Recruitment postcode(s) [2]
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2305 - New Lambton Heights
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Recruitment postcode(s) [3]
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2065 - St Leonards
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Recruitment postcode(s) [4]
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2145 - Westmead
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Recruitment postcode(s) [5]
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4006 - Herston
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Recruitment postcode(s) [6]
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5000 - Adelaide
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Recruitment postcode(s) [7]
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5042 - Bedford Park
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Recruitment postcode(s) [8]
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3004 - Melbourne
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Recruitment postcode(s) [9]
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3052 - Melbourne
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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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Ethics approval
Ethics application status
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Summary
Brief summary
Traumatic Brain Injury (TBI) is a devastating condition and a leading cause of long-term disability. Every patient with TBI has a different type of injury and is treated differently from hospital to hospital making it very difficult to identify the most effective treatments. The current study focuses on the most severe types of TBI that require hospital ICU care - moderate to severe TBI (m-sTBI). The overall aim of this study is to collect data about how different hospitals manage m-sTBI in Australia, and to quantify the variability that likely exists. Recovery at 6 months post-injury will be collected to allow a better understanding on how different injuries and treatments affect long term outcomes.
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Trial website
https://clinicaltrials.gov/study/NCT05855252
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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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Andrew Udy, MB,FCICM,PhD
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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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Andrew Udy, MB,FCICM,PhD
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Address
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Country
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Phone
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+61 (03) 9903 0343
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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/NCT05855252