Multiple TraumaNCT00163826
Spinal Clearance Study: Expediting the Spinal Clearance Process in the Major Trauma Patient
An observational study of Multiple Trauma and Traumatic Brain Injury, run by Bayside Health at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Trauma, Traumatic Brain Injury, Spinal Injuries
- How many people
- 299 participants
- Where
- 1 siteAustralia
- Study dates
- Mar 2004to Aug 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hospital trauma patients
Who may be able to join
- Major trauma patients
Who cannot join
- Patients not subjected to spinal position restrictions on admission
- Patients deceased prior to spinal clearance
- Patients transferred to another centre prior to spinal clearance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimisation of Patient Management Through Expediting the Spinal Clearance Process in the Major Trauma Patient
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.
- Conditions
- Multiple Trauma, Traumatic Brain Injury, Spinal Injuries
- Keywords
- cervical spine injury, multiple trauma
- Medical subject headings
- Multiple Trauma, Brain Injuries, Traumatic, Spinal Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Trauma Patients | Major trauma patients |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startMar 2004
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayside Health
- Sponsor type
- Other government
- Collaborators
- Victorian Trauma Foundation
- Responsible party
- Sponsor
- Investigators
- Helen M Ackland, MHSc, Principal investigator, Bayside Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00163826
- Sponsor's protocol ID
- 163/03
- Status last verified
- Jan 2016
- First submitted
- 12 Sep 2005
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimisation of Patient Management Through Expediting the Spinal Clearance Process in the Major Trauma Patient
- ClinicalTrials.gov ID
- NCT00163826
- Acronym / sponsor ID
- 163/03
- Conditions
- Multiple Trauma, Traumatic Brain Injury, Spinal Injuries
- Keywords
- cervical spine injury, multiple trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- Bayside HealthOther government
- Collaborators
- Victorian Trauma Foundation
- Study start
- Mar 2004
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 14 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trauma Patients | – | –Major trauma patients |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospital trauma patients
Key inclusion criteria (1 listed)
- Major trauma patients
Key exclusion criteria (3 listed)
- Patients not subjected to spinal position restrictions on admission
- Patients deceased prior to spinal clearance
- Patients transferred to another centre prior to spinal clearance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helen M Ackland, MHSc principal investigator
Bayside Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Trauma and Traumatic Brain Injury, run by Bayside Health at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2016.