Trial Review

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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
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
Sex
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
1/03/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2006
Sample size
Target
Accrual to date
Final
299
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
Government body
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/study/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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00163826