Brain Trauma Outcomes in Nova Scotia Study (BTOS)

October 20, 2010 updated by: Queen Elizabeth II Health Sciences Centre

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Measurement; Hours:minutes
Time as measured by ; Time Elapsed from Injury Time to Time of Arrival at Tertiary Care

Secondary Outcome Measures

Outcome Measure
Measure Description
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Elizabeth II Health Sciences Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

October 15, 2010

First Submitted That Met QC Criteria

October 20, 2010

First Posted (Estimate)

October 21, 2010

Study Record Updates

Last Update Posted (Estimate)

October 21, 2010

Last Update Submitted That Met QC Criteria

October 20, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDHA-RS/2004-014
  • PSO-Project- 2003-353 (Other Grant/Funding Number: Nova Scotia Health Research Foundation)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Craniocerebral Trauma

Clinical Trials on Head Injury Guideline

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe