Status:
COMPLETED
Canadian Computed Tomography (CT) Head Rule Study
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Head Injury
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
Background: 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 ...
Eligibility Criteria
Inclusion
- 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.
- 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?').
- 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).
- Injury within the past 24 hours.
Exclusion
- less than 16 years,
- 'minimal' head injury i.e. no loss of consciousness, amnesia, or disorientation,
- no clear history of trauma as the primary event (for example primary seizure or syncope),
- GCS score of less than 13,
- head injury occurred more than 24 hours previously,
- obvious penetrating skull injury or depressed fracture,
- acute focal neurological deficit (motor or cranial nerve) that cannot be ascribed to an extracerebral cause, for example, traumatic mydriasis or peripheral neuropathy,
- have suffered a seizure prior to assessment in the ED,
- a bleeding disorder or current use of oral anticoagulants,125 or
- returned for reassessment of the same head injury
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
4531 Patients enrolled
Trial Details
Trial ID
NCT00993252
Start Date
September 1 2003
End Date
March 1 2009
Last Update
October 15 2010
Active Locations (10)
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1
University of Alberta
Edmonton, Alberta, Canada, T6G 2B7
2
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
3
Royal Columbian Hospital
Westminster, British Columbia, Canada, V3L 3W7
4
St. Thomas Hospital
Elgin, Ontario, Canada