Head Injury Clinical Trial
Official title:
Evaluation of an Active Strategy to Implement the Canadian CT Head Rule: Phase III
Verified date | October 2010 |
Source | Ottawa Hospital Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Ethics Review Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 4531 |
Est. completion date | March 2009 |
Est. primary completion date | January 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 16 Years and older |
Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Canada | University of Alberta | Edmonton | Alberta |
Canada | St. Thomas Hospital | Elgin | Ontario |
Canada | Kingston General Hospital | Kingston | Ontario |
Canada | London Health Sciences Centre | London | Ontario |
Canada | The Ottawa Hospital | Ottawa | Ontario |
Canada | The Ottawa Hospital Civic Campus | Ottawa | Ontario |
Canada | Credit Valley Hospital | Toronto | Ontario |
Canada | Sunnybrook and Women's College HSC | Toronto | Ontario |
Canada | Vancouver General Hospital | Vancouver | British Columbia |
Canada | Royal Columbian Hospital | Westminster | British Columbia |
Lead Sponsor | Collaborator |
---|---|
Ottawa Hospital Research Institute | Canadian Institutes of Health Research (CIHR) |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Computed tomography ordering proportions | January 2009 | No | |
Secondary | Number of missed CTs | January 2009 | Yes | |
Secondary | Number of serious adverse outcomes | January 2009 | Yes | |
Secondary | Length of stay in emergency department (ED) | January 2009 | Yes | |
Secondary | Patient satisfaction | January 2009 | Yes | |
Secondary | Sustainability of the intervention | January 2009 | Yes | |
Secondary | Performance of the Canadian CT Head Rule | January 2009 | Yes | |
Secondary | Economic evaluation measures | January 2009 |
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