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BRAINI-2 Elderly Mild TBI European Study

NCT05425251 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2297

Last updated 2025-12-29

No results posted yet for this 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.

Conditions

  • Mild Traumatic Brain Injury

Interventions

DIAGNOSTIC_TEST

GFAP and UCH-L1

2x5mL blood samples will be used to determine the performance of the automated VIDAS TBI platform in assessing serum concentrations of GFAP and UCH-L1 to rule out the need for a CT-scan after mTBI.

Sponsors & Collaborators

  • Technical University of Munich

    collaborator OTHER

  • University Hospital, Grenoble

    collaborator OTHER

  • University Hospital, Clermont-Ferrand

    collaborator OTHER

  • Hospital Vall d'Hebron

    collaborator OTHER

  • BioMérieux

    collaborator INDUSTRY

  • EIT Health

    collaborator OTHER

  • Hospital Universitario 12 de Octubre

    lead OTHER

Principal Investigators

  • Alfonso Lagares Gómez-Abascal, MD, PhD · Hospital Universitario 12 de Octubre

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2024-12-31
Completion
2025-03-30

Countries

  • France
  • Germany
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05425251 on ClinicalTrials.gov