The Value of the Canadian CT Head Rule and the New Orleans Criteria in Minor Head Trauma

Prediction Value of the Canadian CT Head Rule and the New Orleans Criteria for Positive Head CT Scan and Acute Neurosurgical Procedures in Minor Head Trauma: a Multicenter External Validation Study

The New Orleans Criteria (NOC) and the Canadian CT Head Rules (CCHR) have been developed to decrease the number of normal computed tomography (CT) in mild head injury (MHI). The aim is to compare the clinical performance of these 2 decision rules for indentifying patients with intracranial traumatic lesions and those who required an emergent neurosurgical intervention following MHI.

Study Overview

• Status: Completed
• Conditions: Minor Head Injury
• Intervention / Treatment: Other: no intervention; Other: no intervention

Detailed Description

A multicenter external validation study in 7 Tunisian teaching and non teaching hospitals including patients with MHI defined as a blunt trauma to the head within 24 hours with a Glasgow Coma Scale (GCS) score of 13 to 15 and at least one of the following: history of loss of consciousness, short-term memory deficit, amnesia for the traumatic event, post-traumatic seizure, vomiting, headache, external evidence of injury above the clavicles, confusion, and neurologic deficit. Primary outcome was need for neurosurgical intervention defined as either death or craniotomy, or the need of endotracheal intubation within 30 days of the traumatic event. Secondary outcome was the presence of traumatic lesions on head CT scan. Comparaision of both decision rules using sensitivity specifications, positive and negative predictive value.

• Study Type: Observational
• Enrollment (Actual): 1600

Contacts and Locations

Study Locations

• Tunisia
  • Monastir, Tunisia, 5000
    • Fattouma Bourguiba University Hospital
  • Monastir, Tunisia, 5000
    • University Hospital of Monastir
  • Monstir
    • Monastir, Monstir, Tunisia, 5000
      • University Hospital of Monastir

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with MHI defined as a blunt trauma to the head within 24 hours with a Glasgow Coma Scale (GCS) score of 13 to 15 and at least one of the following: history of loss of consciousness, short-term memory deficit, amnesia for the traumatic event, post-traumatic seizure, vomiting, headache, external evidence of injury above the clavicles, confusion, and neurologic deficit.

Description

Inclusion Criteria:

• Patient with acute MHI was defined as a patient having a blunt trauma to the head within 24 hours with a Glasgow Coma Scale (GCS) of 13 to 15 and at least 1 of the following risk factors: history of loss of consciousness, short-term memory deficit, amnesia for the traumatic event, post-traumatic seizure, vomiting, headache, external evidence of injury above the clavicles, confusion, and neurologic deficit.

Exclusion Criteria:

• Patients are excluded from the study if they are younger than 10 years, had GCS score of less than 13 or instable vital signs, came to the ED more than 24 hours after head trauma, were pregnant, were taking warfarin or had bleeding disorder, had an obvious penetrating skull injury or had contraindications for CT.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients with minor head injury; MHI is defined as a blunt trauma to the head within 24 hours with a Glasgow Coma Scale (GCS) score of 13 to 15 and at least one of the following: history of loss of consciousness, short-term memory deficit, amnesia for the traumatic event, post-traumatic seizure, vomiting, headache, external evidence of injury above the clavicles, confusion, and neurologic deficit.

Other: no intervention; no intervention; Other: no intervention; clinical follow up; Other Names: clinical follow up

Collaborators and Investigators

• Sponsor: University of Monastir
• Investigators: Principal Investigator: Nouira Semir, Prof, Monastir Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: June 12, 2012
• First Submitted That Met QC Criteria: June 13, 2012
• First Posted (Estimate): June 14, 2012

Study Record Updates

• Last Update Posted (Estimate): June 14, 2012
• Last Update Submitted That Met QC Criteria: June 13, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: CT scan; Minor head injury; Canadian CT Head Rules; The New Orleans Criteria
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Craniocerebral Trauma
• Other Study ID Numbers: Head injury