Canadian Computed Tomography (CT) Head Rule Study
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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 |
- Computed tomography ordering proportions [ Time Frame: January 2009 ] [ Designated as safety issue: No ]
- 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) |
-
Procedure: CT Scan
Show Detailed Description
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
- 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 Criteria:
- 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
Contacts and 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 | |
| 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 Trauma, Nervous System Nervous System Diseases Wounds and Injuries |
ClinicalTrials.gov processed this record on May 19, 2013