Prospective, Multicentre, Observational Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Traumatic Brain Injury
- Sponsor
- University Hospital, Grenoble
- Enrollment
- 369
- Locations
- 19
- Primary Endpoint
- Negative predictive value of transcranial doppler
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
Patients with mild to moderate traumatic brain injury (TBI) are at risk for secondary neurological deterioration. Their outcome within the first week after injury could be predicted by clinical signs, brain CT scan and transcranial doppler (TCD) on admission to the emergency room. The investigators aim to evaluate the diagnostic performance of TCD to screen patients presented with mild to moderate TBI and mild lesions on CT scan, i.e., Trauma Coma Data Bank, TCDB classification II. The principal outcome measure is the negative predictive value of TCD.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Negative predictive value of transcranial doppler
Time Frame: within the first week after the injury
Patient with mild to moderate traumatic brain injury (Glasgow Coma Scale 9-15) and a CT scan (TCDB II).TCD is performed within 8 hours after the trauma. Aggravation defined by: * a decrease in the Glasgow Coma Scale of 2 points or more from the initial value, in the absence of pharmacological sedation. * a neurological deterioration sufficient to warrant intervention: mechanical ventilation, sedation, osmotherapy, barbiturates, transfer to more intensive care, or neurosurgical intervention.
Secondary Outcomes
- the impact of transcranial doppler for initial patient management(within the first week after trauma)
- Secondary neurological aggravation: risk factors and consequences.(neurological outcome on D7 and D28)