Text Size

Brain Trauma Outcomes in Nova Scotia Study (BTOS)

This study has been completed.
Sponsor:
Information provided by:
Queen Elizabeth II Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01225692
First received: October 15, 2010
Last updated: October 20, 2010
Last verified: October 2010
History of Changes
  Purpose

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 Intervention
Brain Injuries,Traumatic
Outcome Assessment (Health Care)
Craniocerebral Trauma
Emergency Medical Services
Organizational Innovation
 Behavioral: Head Injury Guideline

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Primary Purpose: Health Services Research
Official Title: Brain Trauma Outcomes in Nova Scotia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Queen Elizabeth II Health Sciences Centre:

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


Secondary Outcome Measures:
  • 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)



Enrollment: 52
Study Start Date: February 2004
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Criteria

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

  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Dr. B. David Clarke, QEII HSC,Capital Health, Dalhousie University, Division of Neursosurgery
ClinicalTrials.gov Identifier: NCT01225692     History of Changes
Other Study ID Numbers: CDHA-RS/2004-014, PSO-Project- 2003-353
Study First Received: October 15, 2010
Last Updated: October 20, 2010
Health Authority: Canada: Ethics Review Committee

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:
Emergencies
Craniocerebral Trauma
Wounds and Injuries
Brain Injuries
Disease Attributes
 Pathologic Processes
Trauma, Nervous System
Nervous System Diseases
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on May 16, 2013