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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00163826
Registration number
NCT00163826
Ethics application status
Date submitted
12/09/2005
Date registered
14/09/2005
Date last updated
8/01/2016
Titles & IDs
Public title
Spinal Clearance Study: Expediting the Spinal Clearance Process in the Major Trauma Patient
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Scientific title
Optimisation of Patient Management Through Expediting the Spinal Clearance Process in the Major Trauma Patient
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Secondary ID [1]
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163/03
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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:
Multiple Trauma
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Traumatic Brain Injury
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Spinal Injuries
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Condition category
Condition code
Injuries and Accidents
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0
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Other injuries and accidents
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Neurological
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Other neurological disorders
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Skin
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0
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Other skin conditions
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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
Trauma Patients - Major trauma patients
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Comparator / control treatment
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Control group
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Outcomes
Eligibility
Key inclusion criteria
* Major trauma patients
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Minimum age
No limit
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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
* Patients not subjected to spinal position restrictions on admission
* Patients deceased prior to spinal clearance
* Patients transferred to another centre prior to spinal clearance
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Study design
Purpose
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Duration
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Selection
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Timing
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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
1/03/2004
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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
1/08/2006
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Sample size
Target
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Accrual to date
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Final
299
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Bayside Health - Melbourne
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Recruitment postcode(s) [1]
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3149 - Melbourne
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Funding & Sponsors
Primary sponsor type
Government body
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Name
Bayside Health
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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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Victorian Trauma Foundation
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The Alfred Hospital receives approximately 40% of the major trauma patients in Victoria, all of whom are at risk for spinal injuries. The potential for spinal injuries necessitates the undertaking of appropriate spinal investigations, and a delay in the completion of these investigations exposes the patient to the risk of a missed diagnosis of spinal instability and of complications of immobility; the potential spinal patient is required to wear a neck collar and be nursed lying flat whilst awaiting the completion and the appropriate documentation of spinal X-ray investigations. The purpose of this study is to identify the issues causing a delay in the process of the completion of the appropriate spinal investigations and the documentation of the results. The outcome of the proposed research will be the development of a clinical management protocol to expedite the process, with the aim of optimising patient care and reducing complications.
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Trial website
https://clinicaltrials.gov/study/NCT00163826
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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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Helen M Ackland, MHSc
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Address
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Bayside Health
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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
No information has been provided regarding IPD availability
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/NCT00163826
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