Blood Biomarkers to Improve Management of Mild Traumatic BRAIN Injury in the Elderly

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
France
CHU Clermont-Ferrand
RECRUITING
Clermont-ferrand
CHU Grenoble-Alpes
RECRUITING
Grenoble
Hôpital Edouard HERRIOT
RECRUITING
Lyon
Hôpital Lyon Sud HCL
RECRUITING
Lyon
Germany
Klinikum rechts der Isar
RECRUITING
Munich
Spain
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Contact Information
Primary
Alfonso Lagares Gómez-Abascal, MD, PhD
alfonso.lagares@salud.madrid.org
+34917792839
Backup
Javier De la Cruz, MD
javier.delacruz@salud.madrid.org
+34917792644
Time Frame
Start Date: 2022-03-01
Estimated Completion Date: 2025-03-30
Participants
Target number of participants: 2850
Treatments
BRAINI2-ELDERLY DIAGNOSTIC & PROGNOSTIC
2370 patients suffering mild Traumatic brain injury
BRAINI2-ELDERLY REFERENCE
480 non-tbi elderly reference patients
Authors
Alfonso Lagares Gómez-Abascal
Related Therapeutic Areas
Sponsors
Collaborators: Hospital Vall d'Hebron, EIT Health, University Hospital, Clermont-Ferrand, University Hospital, Grenoble, Technical University of Munich, BioMérieux
Leads: Hospital Universitario 12 de Octubre

This content was sourced from clinicaltrials.gov