NCT00993252

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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4,531

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2003

Longer than P75 for phase_3

Geographic Reach
1 country

10 active sites

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

September 1, 2003

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

April 21, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
8 months until next milestone

First Posted

Study publicly available on registry

October 12, 2009

Completed
Last Updated

October 15, 2010

Status Verified

October 1, 2010

Enrollment Period

5.3 years

First QC Date

April 21, 2008

Last Update Submit

October 13, 2010

Conditions

Head Injury

Keywords

head injuryradiographyclinical impactdissemination

Outcome Measures

Primary Outcomes (1)

  • Computed tomography ordering proportions

    January 2009

Secondary Outcomes (7)

  • Number of missed CTs

    January 2009

  • Number of serious adverse outcomes

    January 2009

  • Length of stay in emergency department (ED)

    January 2009

  • Patient satisfaction

    January 2009

  • Sustainability of the intervention

    January 2009

  • +2 more secondary outcomes

Interventions

CT ScanPROCEDURE

CT scan

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Royal Columbian Hospital

Westminster, British Columbia, V3L 3W7, Canada

Location

St. Thomas Hospital

Elgin, Ontario, Canada

Location

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 4G5, Canada

Location

The Ottawa Hospital Civic Campus

Ottawa, Ontario, K1Y 4E9, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

Location

Sunnybrook and Women's College HSC

Toronto, Ontario, M4N 3M5, Canada

Location

Credit Valley Hospital

Toronto, Ontario, Canada

Location

Related Publications (1)

  • Stiell IG, Clement CM, Grimshaw JM, Brison RJ, Rowe BH, Lee JS, Shah A, Brehaut J, Holroyd BR, Schull MJ, McKnight RD, Eisenhauer MA, Dreyer J, Letovsky E, Rutledge T, Macphail I, Ross S, Perry JJ, Ip U, Lesiuk H, Bennett C, Wells GA. A prospective cluster-randomized trial to implement the Canadian CT Head Rule in emergency departments. CMAJ. 2010 Oct 5;182(14):1527-32. doi: 10.1503/cmaj.091974. Epub 2010 Aug 23.

    PMID: 20732978DERIVED

MeSH Terms

Conditions

Craniocerebral Trauma

Condition Hierarchy (Ancestors)

Trauma, Nervous SystemNervous System DiseasesWounds and Injuries

Study Officials

  • Ian G Stiell, MD MSc

    University of Ottawa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 21, 2008

First Posted

October 12, 2009

Study Start

September 1, 2003

Primary Completion

January 1, 2009

Study Completion

March 1, 2009

Last Updated

October 15, 2010

Record last verified: 2010-10

Locations

CA(10)