NCT01225692

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2004

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 15, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 21, 2010

Completed
Last Updated

October 21, 2010

Status Verified

October 1, 2010

Enrollment Period

5.3 years

First QC Date

October 15, 2010

Last Update Submit

October 20, 2010

Conditions

Keywords

Brain InjuryHead TraumaTrauma SystemsHead Injury GuidelineTime to Tertiary Care

Outcome Measures

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)

Interventions

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Brain Injuries, TraumaticCraniocerebral TraumaBrain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 15, 2010

First Posted

October 21, 2010

Study Start

February 1, 2004

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

October 21, 2010

Record last verified: 2010-10