Clinical Trials Directory

Trials / Completed

CompletedNCT01619943

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

Status
Completed
Phase
Study type
Observational
Enrollment
1,600 (actual)
Sponsor
University of Monastir · Academic / Other
Sex
All
Age
10 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
OTHERno interventionclinical follow up
OTHERno interventionno intervention

Timeline

Start date
2011-01-01
Primary completion
2011-11-01
Completion
2011-11-01
First posted
2012-06-14
Last updated
2012-06-14

Locations

3 sites across 1 country: Tunisia

Source: ClinicalTrials.gov record NCT01619943. Inclusion in this directory is not an endorsement.