Brain Trauma Outcomes in Nova Scotia Study (BTOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01225692
Recruitment Status : Completed
First Posted : October 21, 2010
Last Update Posted : October 21, 2010
Information provided by:
Queen Elizabeth II Health Sciences Centre

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Brain Injuries,Traumatic Outcome Assessment (Health Care) Craniocerebral Trauma Emergency Medical Services Organizational Innovation Behavioral: Head Injury Guideline Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Intervention Model: Single Group Assignment
Primary Purpose: Health Services Research
Official Title: Brain Trauma Outcomes in Nova Scotia
Study Start Date : February 2004
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Time Measurement; Hours:minutes
    Time as measured by ; Time Elapsed from Injury Time to Time of Arrival at Tertiary Care

Secondary Outcome Measures :
  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)

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All

Retrospective Arm Cohort 1: AIS ≥ 3, head +/- other injuries Cohort 2: AIS ≥ 3, isolated head injury (cohort 2 is a subset of cohort 1)

Inclusion Criteria:

1.patient treated in at least one facility prior to arrival at QEII.

Exclusion Criteria

  1. injured out of province
  2. time from injury to 1st facility presentation known to be > 24 hours
  3. time arrival at 1st referring facility to time arrive at QEII known to be > 24 hours
  4. direct ground or air scene transport

Prospective Arm:

Inclusion Criteria:

  1. have a head injury requiring hospital admission
  2. able to provide informed consent or have next- of -kin able to provide consent on patients' behalf

Exclusion Criteria:

1. unwilling or unable to provide consent

Responsible Party: Dr. B. David Clarke, QEII HSC,Capital Health, Dalhousie University, Division of Neursosurgery Identifier: NCT01225692     History of Changes
Other Study ID Numbers: CDHA-RS/2004-014
PSO-Project- 2003-353 ( Other Grant/Funding Number: Nova Scotia Health Research Foundation )
First Posted: October 21, 2010    Key Record Dates
Last Update Posted: October 21, 2010
Last Verified: October 2010

Keywords provided by Queen Elizabeth II Health Sciences Centre:
Brain Injury
Head Trauma
Trauma Systems
Head Injury Guideline
Time to Tertiary Care

Additional relevant MeSH terms:
Brain Injuries
Wounds and Injuries
Brain Injuries, Traumatic
Craniocerebral Trauma
Disease Attributes
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System