Clinical trial NCT01619943: The Value of the Canadian CT Head Rule and the New Orleans Criteria in Minor Head Trauma
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Minor Head Injury
Keywords: Minor head injury
CT scan
Canadian CT Head Rules
The New Orleans Criteria
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2012-06-14
Enrollment: 1600
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: University Hospital of Monastir
state: Monstir
city: Monastir
country: Tunisia
facility: Fattouma Bourguiba University Hospital
city: Monastir
country: Tunisia
facility: University hospital of Monastir
Study officials:
affiliation: Monastir Hospital
name: Nouira Semir, Prof
role: PRINCIPAL_INVESTIGATOR
References: