Transcranial Doppler on Admission of Patients With Mild to Moderate Traumatic Brain Injury

Completed

• Conditions: Traumatic Brain Injury
• Interventions: Device: Transcranial Doppler

• Registration Number: NCT01291706
• Lead Sponsor: University Hospital, Grenoble

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-07
• Study First Submitted QC: 2011-02-07
• Study First Posted: 2011-02-08
• Primary Completion: 2013-10
• Study Completion: 2013-12
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-25
• Last Update Posted: 2014-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 369

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mild TBI with mild lesions on CT scan	Transcranial Doppler	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)

Primary Outcome Measures

Name	Time	Method
Negative predictive value of transcranial doppler	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 Outcome Measures

Name	Time	Method
the impact of transcranial doppler for initial patient management	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.	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

Trial Locations

Locations (19)

Ch Cannes; 🇫🇷 Cannes, France

Ch Chambery; 🇫🇷 Chambery, France

Ch Voiron; 🇫🇷 Voiron, France

Chu Nimes; 🇫🇷 Nimes, France

Ch Belley; 🇫🇷 Belley, France

CHU Grenoble; 🇫🇷 Grenoble, Isere, France

CHRA Annecy; 🇫🇷 Annecy, Rhone Alpes, France

Ch Saint Jean de Maurienne; 🇫🇷 Saint Jean de Maurienne, France

Ch Thonon Les Bains; 🇫🇷 Thonon Les Bains, France

CH Valence; 🇫🇷 Valence, France

CHU; 🇫🇷 Dijon, France

Ch Grasse; 🇫🇷 Grasse, France

CHU Pierre Benite; 🇫🇷 Lyon, France

Hopitaux Du Pays Du Mont Blanc; 🇫🇷 Sallanches, France

Chu Edouard Herriot; 🇫🇷 Lyon, France

CHU Lyon; 🇫🇷 Lyon, France

CH Nantes; 🇫🇷 Nantes, France

Ch Saint Julien En Genevois; 🇫🇷 St Julien En Genevois, France

Ch Briancon; 🇫🇷 Briancon, France