Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-24 @ 11:48 PM
NCT ID:
NCT05425251
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT05425251
Study Brief:
Protocol Section:
NCT05425251