BRAINI-2 Elderly Mild TBI European Study

Last updated: September 30, 2024
Sponsor: Hospital Universitario 12 de Octubre
Overall Status: Active - Recruiting

Phase

N/A

Condition

Brain Injury

Neurologic Disorders

Treatment

GFAP and UCH-L1

Clinical Study ID

NCT05425251
HU 12Octubre
EIT-HEALTH 220325
  • Ages > 65
  • All Genders
  • Accepts Healthy Volunteers

Study 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, 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.

Eligibility Criteria

Inclusion

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 12hours after injury ;

  • Blood sample obtained ≤12 h after injury and CT scan preferably ≤6h from bloodsample.

  • BRAINI2-ELDERLY REFERENCE:

  • Non TBI patients ≥65 years of age

Exclusion

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 prehospitalmanagement.

  • 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 theinclusion in the study.

Study Design

Total Participants: 2850
Treatment Group(s): 1
Primary Treatment: GFAP and UCH-L1
Phase:
Study Start date:
March 01, 2022
Estimated Completion Date:
March 30, 2025

Connect with a study center

  • CHU Clermont-Ferrand

    Clermont-Ferrand,
    France

    Active - Recruiting

  • CHU Grenoble-Alpes

    Grenoble,
    France

    Active - Recruiting

  • Hôpital Edouard HERRIOT

    Lyon,
    France

    Active - Recruiting

  • Hôpital Lyon Sud HCL

    Lyon,
    France

    Active - Recruiting

  • Klinikum rechts der Isar

    Munich,
    Germany

    Active - Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.