Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01619943
Other study ID # Head injury
Secondary ID
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


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, 

See also
  Status Clinical Trial Phase
Completed NCT04143347 - Outcome of Patients With Mild Head Injury and Presence of an Acute Traumatic Abnormality on CT Scan of Head
Completed NCT02116673 - Influence of Cognitive Rest on Minor Traumatic Brain Injury N/A
Completed NCT01514071 - Animated Picture to Improve Provider Adherence to CT Scan for Head Injury Rule N/A
Completed NCT04702308 - Non-Interruptive Alerts for Improving Use of Clinical Decision Rules N/A
Completed NCT00452036 - Diagnostic Algorithm in Patients With Minor Head Injury N/A
Completed NCT00451789 - Risk Factors of Minor Head Injury N/A