Status:
COMPLETED
BRAINI-2 Elderly Mild TBI European Study
Lead Sponsor:
Hospital Universitario 12 de Octubre
Collaborating Sponsors:
Technical University of Munich
University Hospital, Grenoble
Conditions:
Mild Traumatic Brain Injury
Eligibility:
All Genders
65+ years
Brief Summary
Mild traumatic brain injury (mTBI) is one of the most frequent emergencies in the elderly population. Despite most mTBI are managed with cranial computed tomography (CT), only 10% of CTs show lesions,...
Eligibility Criteria
Inclusion
- BRAINI2-ELDERLY DIAGNOSTIC \& PROGNOSTIC:
- Patients ≥65 years of age
- Mild TBI (GCS 13-15 on admission) with indication of brain CT scan in the 12 hours after injury ;
- Blood sample obtained ≤12 h after injury and CT scan preferably ≤6h from blood sample.
- BRAINI2-ELDERLY REFERENCE:
- Non TBI patients ≥65 years of age
Exclusion
- BRAINI2-ELDERLY DIAGNOSTIC \& PROGNOSTIC:
- Age below 65 years.
- 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 from the trauma scene or prehospital management.
- Venipuncture not feasible
- No realization of brain CT-scan
- Subject under judiciary control
- Subject in inclusion period of a drug interventional study
- BRAINI2-ELDERLY REFERENCE:
- Subject in inclusion period of another drug interventional study
- Patients harboring a brain tumor
- Patients that have had a stroke or neurosurgical operation 1 month prior to the inclusion in the study.
Key Trial Info
Start Date :
March 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 30 2025
Estimated Enrollment :
2297 Patients enrolled
Trial Details
Trial ID
NCT05425251
Start Date
March 1 2022
End Date
March 30 2025
Last Update
December 29 2025
Active Locations (7)
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1
CHU Clermont-Ferrand
Clermont-Ferrand, France
2
CHU Grenoble-Alpes
Grenoble, France
3
Hôpital Edouard HERRIOT
Lyon, France
4
Hôpital Lyon Sud HCL
Lyon, France