Transcranial Doppler on Admission of Patients With Mild to Moderate Traumatic Brain Injury (TCD)
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|ClinicalTrials.gov Identifier: NCT01291706|
Recruitment Status : Completed
First Posted : February 8, 2011
Last Update Posted : April 28, 2014
|Condition or disease||Intervention/treatment|
|Traumatic Brain Injury||Device: Transcranial Doppler|
|Study Type :||Observational|
|Actual Enrollment :||369 participants|
|Official Title:||Prospective, Multicentre, Observational Study|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||December 2013|
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
- 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.
- the impact of transcranial doppler for initial patient management [ Time Frame: within the first week after trauma ]
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 ]
Neurological outcome on day 7 and day 28 after trauma, as measured with disability rating scale.
Number and type of interventions for neurological deterioration
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01291706
|Grenoble, Isere, France, 38043|
|Annecy, Rhone Alpes, France, 74000|
|Clermont Ferrand, France|
|Chu Edouard Herriot|
|CHU Pierre Benite|
|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||University Hospital, Grenoble|