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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
Scientific title
Optimisation of Patient Management Through Expediting the Spinal Clearance Process in the Major Trauma Patient
Secondary ID [1] 0 0
163/03
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Trauma 0 0
Traumatic Brain Injury 0 0
Spinal Injuries 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Neurological 0 0 0 0
Other neurological disorders
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Trauma Patients - Major trauma patients

Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
- Major trauma patients
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Bayside Health - Melbourne
Recruitment postcode(s) [1] 0 0
3149 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Bayside Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Victorian Trauma Foundation
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00163826
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Helen M Ackland, MHSc
Address 0 0
Bayside Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications