BRAINI-2 Elderly Mild TBI European Study (BRAINI2ELDER)

Madrid Health Service

Status

Enrolling

Conditions

Mild Traumatic Brain Injury

Treatments

Diagnostic Test: GFAP and UCH-L1

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT05425251

EIT-HEALTH 220325 (Other Grant/Funding Number)

HU 12Octubre

Details and patient eligibility

About

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, determining CT overuse. The use of serum glial fibrillary acidic protein (GFAP) and Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) have shown potential for ruling out the need for cranial CT. However evidence on biomarker use in mild TBI were not based on studies that included aged participants and patients with comorbidities for which biomarker levels could vary. This is why there is a need for a prospective study that assesses the predictive performance of these two biomarkers in the elderly population, both in elderly patients suffering mild TBI and in a reference population, including patients and participants with and without comorbidities.

Enrollment

2,850 estimated patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

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.