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

Minor Head Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01619943
• Other study ID #: Head injury
• Status: Completed
• Phase: N/A
• First received: June 12, 2012
• Last updated: June 13, 2012
• Start date: January 2011
• Est. completion date: November 2011

Study information

• Verified date: June 2012
• Source: University of Monastir
• Contact: n/a
• Is FDA regulated: No
• Health authority: Tunisia: Ministry of Public Health
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1600
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Craniocerebral Trauma
• Minor Head Injury

Intervention

Other:
• no intervention
clinical follow up
• no intervention
no intervention

Locations

Country	Name	City	State
Tunisia	Fattouma Bourguiba University Hospital	Monastir
Tunisia	University hospital of Monastir	Monastir
Tunisia	University Hospital of Monastir	Monastir	Monstir

Sponsors (1)

Lead Sponsor	Collaborator
University of Monastir

Country where clinical trial is conducted

Tunisia,