NCT05425251

BRAINI-2 Elderly Mild TBI European Study

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,297 (actual)
• Sponsor: Hospital Universitario 12 de Octubre · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2022-03-01
• Primary completion: 2024-12-31
• Completion: 2025-03-30
• First posted: 2022-06-21
• Last updated: 2025-12-29

Locations

7 sites across 3 countries: France, Germany, Spain