Canadian Computed Tomography (CT) Head Rule Study

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00993252
First received: April 21, 2008
Last updated: October 13, 2010
Last verified: October 2010
  Purpose

Each year, Canadian emergency department physicians treat 600,000 patients with head injury. Many of these are adults with "minor head injury", i.e. loss of consciousness or amnesia and a Glasgow Coma Scale (GCS) score of 13-15. Only 6.2% of these "minor" patients have some acute injury on computed tomography (CT scan) and only 0.5% have an epidural hematoma requiring surgery. Among Canadian teaching hospital emergency departments, we have shown a fourfold variation in use of CT and that a small but important number of intracranial hematomas are missed at the first visit.


Condition Intervention Phase
Head Injury
Procedure: CT Scan
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of an Active Strategy to Implement the Canadian CT Head Rule: Phase III

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Computed tomography ordering proportions [ Time Frame: January 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of missed CTs [ Time Frame: January 2009 ] [ Designated as safety issue: Yes ]
  • Number of serious adverse outcomes [ Time Frame: January 2009 ] [ Designated as safety issue: Yes ]
  • Length of stay in emergency department (ED) [ Time Frame: January 2009 ] [ Designated as safety issue: Yes ]
  • Patient satisfaction [ Time Frame: January 2009 ] [ Designated as safety issue: Yes ]
  • Sustainability of the intervention [ Time Frame: January 2009 ] [ Designated as safety issue: Yes ]
  • Performance of the Canadian CT Head Rule [ Time Frame: January 2009 ] [ Designated as safety issue: Yes ]
  • Economic evaluation measures [ Time Frame: January 2009 ]

Enrollment: 4531
Study Start Date: September 2003
Study Completion Date: March 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: CT Scan
    CT scan
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Consecutive adult patients presenting to one of the study hospital EDs after sustaining acute minor head injury will be enrolled into the study. Eligibility as an 'acute minor head injury' case will be determined by the patient having all of the following characteristics upon arrival in the ED.

  1. Blunt trauma to the head resulting in witnessed loss of consciousness, definite amnesia, or witnessed disorientation, no matter how brief; this may be determined from the patient or from the report of a witness (the patient will be asked specific questions: 'do you remember the accident?', 'how did you get to the hospital?', 'have you talked to me before?').
  2. Initial ED GCS score of 13 or greater as ascertained by the attending physician (e.g. opens eyes spontaneously, obeys commands, but speech may include only comprehensible but inappropriate words).
  3. Injury within the past 24 hours.

Exclusion Criteria:

  1. less than 16 years,
  2. 'minimal' head injury i.e. no loss of consciousness, amnesia, or disorientation,
  3. no clear history of trauma as the primary event (for example primary seizure or syncope),
  4. GCS score of less than 13,
  5. head injury occurred more than 24 hours previously,
  6. obvious penetrating skull injury or depressed fracture,
  7. acute focal neurological deficit (motor or cranial nerve) that cannot be ascribed to an extracerebral cause, for example, traumatic mydriasis or peripheral neuropathy,
  8. have suffered a seizure prior to assessment in the ED,
  9. a bleeding disorder or current use of oral anticoagulants,125 or
  10. returned for reassessment of the same head injury
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00993252

Locations
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Royal Columbian Hospital
Westminster, British Columbia, Canada, V3L 3W7
Canada, Ontario
St. Thomas Hospital
Elgin, Ontario, Canada
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
London Health Sciences Centre
London, Ontario, Canada, N6A 4G5
The Ottawa Hospital Civic Campus
Ottawa, Ontario, Canada, K1Y 4E9
The Ottawa Hospital
Ottawa, Ontario, Canada, K1Y 4E9
Sunnybrook and Women's College HSC
Toronto, Ontario, Canada, M4N 3M5
Credit Valley Hospital
Toronto, Ontario, Canada
Sponsors and Collaborators
Ottawa Hospital Research Institute
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Ian G Stiell, MD MSc University of Ottawa
  More Information

No publications provided by Ottawa Hospital Research Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Ian Stiell, OHRI
ClinicalTrials.gov Identifier: NCT00993252     History of Changes
Other Study ID Numbers: 42521, 2003165-01H
Study First Received: April 21, 2008
Last Updated: October 13, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by Ottawa Hospital Research Institute:
head injury
radiography
clinical impact
dissemination

Additional relevant MeSH terms:
Craniocerebral Trauma
Wounds and Injuries
Trauma, Nervous System
Nervous System Diseases

ClinicalTrials.gov processed this record on April 17, 2014