Status:
COMPLETED
A Study of Biomarkers of Mild Traumatic BRAIN Injury
Lead Sponsor:
University Hospital, Grenoble
Conditions:
Mild Traumatic Brain Injury
Eligibility:
All Genders
18+ years
Brief Summary
Patients with mild traumatic brain injury (mTBI) represent a burden of patients admitted to the emergency department. According to the guidelines, a cerebral CT scan is indicated after mTBI according ...
Eligibility Criteria
Inclusion
- Patients \>18 years old (France)
- Mild TBI (GCS 13-15 on admission) within 12 hours after injury
- Indication of brain CT scan:
- neurological focal deficit
- anterograde amnesia
- Glasgow coma scale score \<15 after 2 hours post-TBI
- suspicion of vault depression fracture
- fracture of the basal skull
- persisting nausea, vomiting or headache
- post-TBI seizures
- Pre-injury treatment with antithrombotic drugs
- Loss of consciousness or amnesia with age \>65 years, fall \>1m or hit pedestrian
- Other condition requiring CT scan according to the in-charge physician.
Exclusion
- GCS 3-12 on admission
- Time of injury unknown
- Time to injury exceeding 12 hours
- Primary admission for non-traumatic neurological disorder (e.g., stroke, spontaneous intracranial hematoma)
- Penetrating head trauma
- Patient with mechanical ventilation
- Pre-injury neurological disorder affecting the assessment of neurological outcome: dementia, Parkinson's disease, multiple sclerosis, seizure disorder, brain tumor, and history of neurosurgery, stroke or transient ischemic attack (TIA) within the last 30 days
- Venipuncture not feasible
- No realization of brain CT-scan
- Subject under judiciary control
- Pregnant or breastfeeding woman
- Subject in exclusion period of another study
Key Trial Info
Start Date :
August 10 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 28 2021
Estimated Enrollment :
1501 Patients enrolled
Trial Details
Trial ID
NCT04032509
Start Date
August 10 2019
End Date
September 28 2021
Last Update
March 2 2022
Active Locations (16)
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1
Centre Hospitalier Annecy Genevois
Annecy, France
2
CHU Bordeaux
Bordeaux, France
3
CHU Dijon
Dijon, France
4
CHU Grenoble Alpes
Grenoble, France