BRAINI-2 Elderly Mild TBI European Study

Hospital Universitario 12 de Octubre2,297 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

2,297

Conditions

Mild Traumatic Brain Injury

Interventions

GFAP and UCH-L1DIAGNOSTIC_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.

Eligibility

Sex: ALLMin age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 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 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 prehospital management. * 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 the inclusion in the study.

Locations (7)

CHU Clermont-Ferrand

Clermont-Ferrand, France

CHU Grenoble-Alpes

Grenoble, France

Hôpital Edouard HERRIOT

Lyon, France

Hôpital Lyon Sud HCL

Lyon, France

Klinikum rechts der Isar

Munich, Germany

Hospital Universitario 12 de Octubre

Madrid, Madrid, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Outcomes

Primary Outcomes

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

Time frame: 12 hours after mild TBI

Secondary Outcomes

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

Early and midterm biomarker predictive performance in terms of predicting neurological outcome. Neurological status at 1 week and 3 months after TBI and Rivermead post concussion questionnaire.

Time frame: 1 week and 3 months

GFAP reference values

GFAP serum level distribution in the non-TBI reference population, considering age and comorbidities.

Time frame: 1 Day, day of extraction of the sample

UCHL-1 reference values

UCHL-1 serum level distribution in the non-TBI reference population, considering age and comorbidities.

Time frame: 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

Early and midterm biomarker predictive performance in terms of predicting neurological outcome. Extended Glasgow Outcome Score (GOSE)

Time frame: 1 week and 3 months

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

Early and midterm biomarker predictive performance in terms of predicting quality of life after mild TBI assessed by Qolibri-OS

Time frame: 1 week and 3 months

Determination of the potential of the two biomarkers in predicting quality of life assessed by EQ-5D-5L after TBI

Midterm biomarker predictive performance in terms of predicting quality of life after mild TBI assessed by EQ-5D-5L

Time frame: 3 months

Determination of the potential of the two biomarkers in depression symptoms assessed by PHQ-9 after TBI

Midterm biomarker predictive performance in terms of predicting depression symptoms after mild TBI assessed by PHQ-9

Time frame: 3 months