BRAINI-2 Elderly Mild TBI European Study

NCT05425251 | Completed DMC

• 2 other identifiers: HU 12OctubreEIT-HEALTH 220325
• Study Type: observational
• Target: 2,297
• Locations: 3 countries
• Sites: 7

Brief 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

Outcome Measures

Primary Outcomes (1)

• Biomarkers diagnostic performance

  Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of GFAP and UCHL-1 used separately and in combination to detect the presence or absence of intracranial lesions on CT scan

  12 hours after mild TBI

Secondary Outcomes (7)

• Determination of the potential of the two biomarkers in predicting neurological symptoms after TBI

  1 week and 3 months

• GFAP reference values

  1 Day, day of extraction of the sample

• UCHL-1 reference values

  1 Day, day of extraction of the sample

• Determination of the potential of the two biomarkers in predicting neurological outcome assessed by the Extended Glasgow Outcome Score (GOSE) after TBI

  1 week and 3 months

• Determination of the potential of the two biomarkers in predicting quality of life assessed by Qolibri-OS after TBI

  1 week and 3 months

Study Arms (2)

BRAINI2-ELDERLY DIAGNOSTIC & PROGNOSTIC

2370 patients suffering mild Traumatic brain injury

Diagnostic Test: GFAP and UCH-L1

BRAINI2-ELDERLY REFERENCE

480 non-tbi elderly reference patients

Diagnostic Test: GFAP and UCH-L1

Interventions

GFAP and UCH-L1 DIAGNOSTIC_TEST

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.

BRAINI2-ELDERLY DIAGNOSTIC & PROGNOSTIC; BRAINI2-ELDERLY REFERENCE

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

2370 participants suffering mild TBI; 480 non TBI participants.

You may qualify if:

• 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

You may not qualify if:

• 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
• BRAINI2-ELDERLY REFERENCE:
• Patients harboring a brain tumor

Sponsors & Collaborators

• Hospital Universitario 12 de Octubre: lead
• Hospital Vall d'Hebron: collaborator
• Technical University of Munich: collaborator
• University Hospital, Grenoble: collaborator
• University Hospital, Clermont-Ferrand: collaborator
• BioMérieux: collaborator
• EIT Health: collaborator

Study Sites (7)

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location

CHU Grenoble-Alpes

Grenoble, France

Location

Hôpital Edouard HERRIOT

Lyon, France

Location

Hôpital Lyon Sud HCL

Lyon, France

Location

Klinikum rechts der Isar

Munich, Germany

Location

Hospital Universitario 12 de Octubre

Madrid, Madrid, 28041, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Location

Related Publications (1)

• Lagares A, Payen JF, Biberthaler P, Poca MA, Mejan O, Pavlov V, Viglino D, Sapin V, Lassaletta A, de la Cruz J; Braini2_elderly_investigators Collaborative group. Study protocol for investigating the clinical performance of an automated blood test for glial fibrillary acidic protein and ubiquitin carboxy-terminal hydrolase L1 blood concentrations in elderly patients with mild traumatic BRAIN Injury and reference values (BRAINI-2 Elderly European study): a prospective multicentre observational study. BMJ Open. 2023 Jul 17;13(7):e071467. doi: 10.1136/bmjopen-2022-071467.

  PMID: 37460257 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Alfonso Lagares Gómez-Abascal, MD, PhD

  Hospital Universitario 12 de Octubre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Neurosurgery, Head

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: June 21, 2022
• Study Start: March 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: March 30, 2025
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4); DE (1); ES (2)