VIDAS® TBI Real Life Performance in Subjects with Mild Traumatic Brain Injury (mTBI)

bioMérieux

Status: Enrolling

Conditions: Mild Traumatic Brain Injury

Treatments: Diagnostic Test: VIDAS® TBI Test [GFAP and UCH-L1 assays]

Study type: Interventional

Funder types: Industry

Identifiers

NCT06449183

BM-2023-12

Details and patient eligibility

About

Decision Rules for an initial CT-scan in patients arriving to Emergency Department (ED) and presenting a mild traumatic brain injury could be optimized by the use of an objective parameter easily and rapidly measured. This may be the place for serum biomarkers providing a quick and accurate assessment. BioMérieux has now developed an automated assay for the measurement of serum Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase (UCH-L1), the VIDAS® TBI assay to fill out this unmet needs. The goal of the herein study is to generate real-world data and evidences to support the VIDAS® TBI performances.

Full description

The assessment of severity of TBI patients is based on the Glasgow Coma Scale (GCS) and the initial management in the ED includes performing a non-contrast brain Computed Tomography (CT) scan if the patient meets specific conditions. To date, real world data show that EDs would actually not follow guideline recommendations and a substantial CT overuse is observed. Management strategies are becoming more and more focused on selective CT use to effectively manage health care resources. Efforts have been made to optimize the indications for brain CT scan after mTBI. Although brain CT scan plays a central role after mTBI, there is an unmet clinical need for an objective tool to optimize indications for CT scan, reduce patient radiation exposure, and possibly predict patient outcome. Clinical Decision Rules for an initial CT-scan could be optimized by the use of an objective parameter easily and rapidly measured. This may be the place for serum biomarkers providing a quick and accurate assessment. BioMérieux has now developed an automated assay for the measurement of serum Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase (UCH-L1), the VIDAS® TBI assay to fill out this unmet needs. The goal of the herein study is to generate real-world data and evidences to support the VIDAS® TBI performances.

Enrollment: 900 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult subject ≥ 18 years old
• Subject with a Glasgow Coma Scale (GCS) score between 13-15 on admission
• Subject presenting to the Emergency Department for suspected mild Traumatic Brain Injury
• Subject with a non-contrast head Computed Tomography (CT) scan ordered per the clinical site's care usual care
• Blood sampling possible within 12 hours of injury (1 tube of 4-5 mL of blood)
• Subject expected to stay at least 2 hours in the ED or in a ward
• Subject with signed Informed Consent Form (ICF)

Exclusion criteria

• Time of injury unknown
• Subject with non-traumatic neurological disorders (e.g, dementia, Parkinson's disease, multiple sclerosis, seizure disorder, brain tumors, spontaneous intracranial haematoma)
• Neurosurgery, stroke or transient ischemic attack within the last 30 days
• Subject with an active cancer
• Subject with penetrating head injury
• Special populations, including women with known pregnancy, prisoners, or institutionalized individuals

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

900 participants in 1 patient group

Subjects with Mild Traumatic Brain injury

Experimental group

Description:

Subjects presenting to the ED within 12 hours of suspected mild head trauma and a Glasgow Score of 13-15 undergo to blood collection for VIDAS® TBI \[GFAP, UCH-L1\] testing.

Treatment:

Diagnostic Test: VIDAS® TBI Test [GFAP and UCH-L1 assays]