Brain Trauma Outcomes in Nova Scotia Study

Craniocerebral Trauma Clinical Trial

— BTOS  

Official title:

Brain Trauma Outcomes in Nova Scotia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01225692
• Other study ID #: CDHA-RS/2004-014
• Secondary ID: PSO-Project- 200
• Status: Completed
• Phase: N/A
• First received: October 15, 2010
• Last updated: October 20, 2010
• Start date: February 2004
• Est. completion date: June 2009

Study information

• Verified date: October 2010
• Source: Queen Elizabeth II Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Head Injury Guideline

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Queen Elizabeth II Health Sciences Centre

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time Measurement; Hours:minutes	Time as measured by ; Time Elapsed from Injury Time to Time of Arrival at Tertiary Care
Secondary	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)