Transcranial Doppler on Admission of Patients With Mild to Moderate Traumatic Brain Injury (TCD)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Prospective, Multicentre, Observational Study|
- Negative predictive value of transcranial doppler [ Time Frame: within the first week after the injury ] [ Designated as safety issue: Yes ]
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.
- the impact of transcranial doppler for initial patient management [ Time Frame: within the first week after trauma ] [ Designated as safety issue: No ]
Number of brain CTscan performed within 7 days after the trauma.
Number of devices inserted to monitor intracranial pressure.
Secondary admissions to intensive care unit.
Length of hospital stay.
- Secondary neurological aggravation: risk factors and consequences. [ Time Frame: neurological outcome on D7 and D28 ] [ Designated as safety issue: No ]
Neurological outcome on day 7 and day 28 after trauma, as measured with disability rating scale.
Number and type of interventions for neurological deterioration
|Study Start Date:||February 2011|
|Study Completion Date:||December 2013|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Mild TBI with mild lesions on CT scan
Negative predictive value of transcranial doppler for patients with mild to moderate traumatic brain injury and mild brain lesions on initial CT scan (TCDB II)
Device: Transcranial Doppler
Negative predictive value of transcranial doppler in patients with mild to moderate traumatic brain injury
Please refer to this study by its ClinicalTrials.gov identifier: NCT01291706
|Grenoble, Isere, France, 38043|
|Annecy, Rhone Alpes, France, 74000|
|Clermont Ferrand, France|
|CHU Pierre Benite|
|Chu Edouard Herriot|
|Ch Saint Jean de Maurienne|
|Saint Jean de Maurienne, France|
|Hopitaux Du Pays Du Mont Blanc|
|Ch Saint Julien En Genevois|
|St Julien En Genevois, France|
|Ch Thonon Les Bains|
|Thonon Les Bains, France|
|Principal Investigator:||Jean Francois Payen, MD||CHU Grenoble|