Prospective, Multicentre, Observational Study

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

Sponsors

Lead sponsor: University Hospital, Grenoble

Collaborator: CIC Clinical Investigation Centre Grenoble

Source 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.

Overall Status Completed
Start Date February 2011
Completion Date December 2013
Primary Completion Date October 2013
Study Type Observational
Primary Outcome
Measure Time Frame
Negative predictive value of transcranial doppler within the first week after the injury
Secondary Outcome
Measure Time Frame
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
Enrollment 369
Condition
Intervention

Intervention type: Device

Intervention name: Transcranial Doppler

Description: Negative predictive value of transcranial doppler in patients with mild to moderate traumatic brain injury

Arm group label: Mild TBI with mild lesions on CT scan

Eligibility

Sampling method: Non-Probability Sample

Criteria:

Criteria for inclusion:

- 15 years of age or more

- primary admission for mild TBI (GCS 14-15) or moderate (GCS 9-13) TBI.

- with or without multiple injury.

- with no hemodynamic or respiratory distress: SAP >90mmHg, SPO2 >92%,hemoglobin > 8 g/dl.

- with mild brain lesions on CTscan according to the traumatic coma data bank classification (TCDB) II: diffuse injury with cisterns present and no midline shift, mixed density lesions <25 ml.

- Transcranial Doppler within 8 hours after the trauma.

- patient affiliated to the social security system or equivalent

Criteria for exclusion:

- Severe TBI (GCS<9)

- Penetrating TBI

- patient with no brain CT scan

- patient with normal brain CT scan (TCDB I), or severe brain CT scan (TCDB III-IV)

- Hemodynamic or respiratory distress

- Patient treated with anticoagulants: oral anticoagulant, heparin, anti-platelet agent (except Aspirin)

- previous intracranial surgery

- Patient with sedation and mechanical ventilation

- transcranial Doppler unable

- patient deprived of freedom by judicial or administrative decision

- Follow up at 7 days impossible

- Refusal consent to use data for statistics

Gender: All

Minimum age: 15 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Jean Francois Payen, MD Principal Investigator University Hospital, Grenoble
Location
facility
CHU Grenoble
CHRA Annecy
Ch Belley
CHU
Ch Briancon
Ch Cannes
Ch Chambery
CHU
CHU
Ch Grasse
Chu Edouard Herriot
CHU Lyon
CHU Pierre Benite
CH Nantes
Chu Nimes
Ch Saint Jean de Maurienne
Hopitaux Du Pays Du Mont Blanc
Ch Saint Julien En Genevois
Ch Thonon Les Bains
CH Valence
Ch Voiron
Location Countries

France

Verification Date

April 2014

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Mild TBI with mild lesions on CT scan

Description: 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)

Acronym TCD
Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov