Brain Trauma Outcomes in Nova Scotia Study

NCT ID: NCT01225692

Last Updated: 2010-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2009-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Brain Injuries,Traumatic Outcome Assessment (Health Care) Craniocerebral Trauma Emergency Medical Services Organizational Innovation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Interventions

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Head Injury Guideline

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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


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. 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:


1\. unwilling or unable to provide consent
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Queen Elizabeth II Health Sciences Centre

OTHER

Sponsor Role lead

Responsible Party

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QEII HSC,Capital Health, Dalhousie University, Division of Neursosurgery

Other Identifiers

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PSO-Project- 2003-353

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CDHA-RS/2004-014

Identifier Type: -

Identifier Source: org_study_id