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Completed

NCT Number: NCT01225692

Brain Trauma Outcomes in Nova Scotia Study

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.

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Key information

Conditions

Brain Injuries,Traumatic Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Emergency Medical Services Nervous System Diseases Organizational Innovation Outcome Assessment (Health Care) Trauma, Nervous System Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

  • 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:

Inclusion criteria

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

Exclusion criteria

  • unwilling or unable to provide consent

Treatment and study plan

Head Injury Guideline

Behavioral

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Queen Elizabeth II Health Sciences Centre

Other

Registry information

Official study title

Brain Trauma Outcomes in Nova Scotia

Acronym: BTOS

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Oct 21, 2010
Registry last updated
Oct 21, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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