Brain Injuries,TraumaticBTOSNCT01225692
Brain Trauma Outcomes in Nova Scotia Study
A study testing Head Injury Guideline in people with Brain Injuries,Traumatic and Outcome Assessment (Health Care), run by Queen Elizabeth II Health Sciences Centre.
Trial summary
The goals of this study are to identify outcome indicators of optimal care for brain injury patients, including pre-hospital care, prompt delivery to neurosurgical care and access to early rehabilitation services. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Brain Injuries,Traumatic, Outcome Assessment (Health Care), Craniocerebral Trauma
- What is being tested?
- Head Injury Guideline
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Feb 2004to Jun 2009
- Phase
- Interventional
- 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
- Child, Adult, Older adult
Who may be able to join
- 1.patient treated in at least one facility prior to arrival at QEII.
- have a head injury requiring hospital admission
- able to provide informed consent or have next- of -kin able to provide consent on patients' behalf
Who cannot join
- injured out of province
- time from injury to 1st facility presentation known to be > 24 hours
- time arrival at 1st referring facility to time arrive at QEII known to be > 24 hours
- direct ground or air scene transport
- Prospective Arm:
- 1. unwilling or unable to provide consent
About this study
Official title: Brain Trauma Outcomes in Nova Scotia
The goals of this study are to identify outcome indicators of optimal care for brain injury patients, including pre-hospital care, prompt delivery to neurosurgical care and access to early rehabilitation services. Nova Scotia's centralized Neurosurgical services and integrated provincial Emergency Health Services provide a rich opportunity to construct a cohesive, integrated data management system. This system will allow us to answer important research questions related to the outcomes, care and prevention of brain trauma.
Retrospective data collection The retrospective arm of the BTO study has created full data sets and care pathways from multiple sources covering the continuum of brain trauma care. Investigators continue to analyze this large amount of data and prepare it for publication.
Prospective data Collection Patients with a major head injury (initial GCS 3-12), have been considered for enrollment in the BTO study.The prospective arm of the BTO study has 52 patients enrolled. Screening and Enrollment was complete on June 30, 2007. These patients are participating in long term follow up at 6, 12 and 24 months post injury for assessment of qualitative and quantitative outcomes. Completion of patient follow up will be in June 2009.
- Conditions
- Brain Injuries,Traumatic, Outcome Assessment (Health Care), Craniocerebral Trauma, Emergency Medical Services, Organizational Innovation
- Being tested
- Head Injury Guideline
- Keywords
- Brain Injury, Head Trauma, Trauma Systems, Head Injury Guideline, Time to Tertiary Care
- Medical subject headings
- Brain Injuries, Traumatic, Craniocerebral Trauma, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Head Injury GuidelineBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Measurement; Hours:minutes
Time as measured by ; Time Elapsed from Injury Time to Time of Arrival at Tertiary Care
Secondary outcomes (1)
Clinical Follow-up; Numerical Score 1-5;Glasgow Outcome Scores (GOS)
Glasgow Outcome Scores (GOS)
Score ranges from:
5 Good Recovery (Resumption of normal life despite minor deficits) 4 Moderate Disability(Disabled but independent. Can work in sheltered setting) 3 Severe Disability (Conscious but disabled. Dependent for daily support) 2 Persistent vegetative (Minimal responsiveness)
1 Death (Non survival)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2010 (estimated)
- Study startFeb 2004
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injuries,TraumaticStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Elizabeth II Health Sciences Centre
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01225692
- Sponsor's protocol ID
- CDHA-RS/2004-014
- Other IDs
- PSO-Project- 2003-353
- Acronym
- BTOS
- Status last verified
- Oct 2010
- First submitted
- 15 Oct 2010
- Last updated
- 21 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Trauma Outcomes in Nova Scotia
- ClinicalTrials.gov ID
- NCT01225692
- Acronym / sponsor ID
- BTOS / CDHA-RS/2004-014
- Conditions
- Brain Injuries,Traumatic, Outcome Assessment (Health Care), Craniocerebral Trauma, Emergency Medical Services, Organizational Innovation
- Keywords
- Brain Injury, Head Trauma, Trauma Systems, Head Injury Guideline, Time to Tertiary Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Queen Elizabeth II Health Sciences CentreUniversity, hospital or other
- Study start
- Feb 2004
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 21 Oct 2010 (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 goals of this study are to identify outcome indicators of optimal care for brain injury patients, including pre-hospital care, prompt delivery to neurosurgical care and access to early rehabilitation services. Nova Scotia's centralized Neurosurgical services and integrated provincial Emergency Health Services provide a rich opportunity to construct a cohesive, integrated data management system. This system will allow us to answer important research questions related to the outcomes, care and prevention of brain trauma.
Retrospective data collection The retrospective arm of the BTO study has created full data sets and care pathways from multiple sources covering the continuum of brain trauma care. Investigators continue to analyze this large amount of data and prepare it for publication.
Prospective data Collection Patients with a major head injury (initial GCS 3-12), have been considered for enrollment in the BTO study.The prospective arm of the BTO study has 52 patients enrolled. Screening and Enrollment was complete on June 30, 2007. These patients are participating in long term follow up at 6, 12 and 24 months post injury for assessment of qualitative and quantitative outcomes. Completion of patient follow up will be in June 2009.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 1.patient treated in at least one facility prior to arrival at QEII.
- have a head injury requiring hospital admission
- able to provide informed consent or have next- of -kin able to provide consent on patients' behalf
Key exclusion criteria (6 listed)
- injured out of province
- time from injury to 1st facility presentation known to be > 24 hours
- time arrival at 1st referring facility to time arrive at QEII known to be > 24 hours
- direct ground or air scene transport
- 1. unwilling or unable to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Head Injury Guideline | Behavioural | – |
Primary outcome
Time Measurement; Hours:minutes
Time as measured by ; Time Elapsed from Injury Time to Time of Arrival at Tertiary Care
1 secondary outcome
Clinical Follow-up; Numerical Score 1-5;Glasgow Outcome Scores (GOS)
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 21 Oct 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Head Injury Guideline in people with Brain Injuries,Traumatic and Outcome Assessment (Health Care), run by Queen Elizabeth II Health Sciences Centre.
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 3 inclusion and 6 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 21 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
Time Measurement; Hours:minutes. It is what the study was designed to measure, not a finding.
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 21 Oct 2010.