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

NCT ID: NCT06449183

Last Updated: 2024-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-16

Study Completion Date

2025-11-16

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Mild Traumatic Brain Injury

Keywords

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Mild Traumatic Brain Injury mTBI TBI Biomarkers Automated assays Ubiquitin Carboxy-terminal Hydrolase-L1 (UCH-L1) Glial Fibrillary Acidic Protein (GFAP) Canadian CT Head Rule Canadian CT Head Rule (CCHR) Performance Economic outcomes Clinical outcomes CT-Scan Emergency Department (ED)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single Prospective Cohort. Multicentric, International clinical study.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Subjects with Mild Traumatic Brain injury

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.

Group Type EXPERIMENTAL

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

Intervention Type DIAGNOSTIC_TEST

The VIDAS® TBI (GFAP, UCH-L1) test is composed of two automated assays - VIDAS® TBI (GFAP) and VIDAS® TBI (UCH-L1) - to be used on the VIDAS® family of instruments for the quantitative measurement of Glial 15 Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase- L1 (UCH-L1) in human serum using the Enzyme Linked Fluorescent Assay (ELFA) technique. The results of both assays are required to obtain an overall qualitative test interpretation.

Interventions

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

The VIDAS® TBI (GFAP, UCH-L1) test is composed of two automated assays - VIDAS® TBI (GFAP) and VIDAS® TBI (UCH-L1) - to be used on the VIDAS® family of instruments for the quantitative measurement of Glial 15 Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase- L1 (UCH-L1) in human serum using the Enzyme Linked Fluorescent Assay (ELFA) technique. The results of both assays are required to obtain an overall qualitative test interpretation.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BioMérieux

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Orlando Health

Orlando, Florida, United States

Site Status RECRUITING

Wayne State University

Detroit, Michigan, United States

Site Status RECRUITING

Mayo Clinic

Rochester, Minnesota, United States

Site Status RECRUITING

Washington University

St Louis, Missouri, United States

Site Status RECRUITING

University of Rochester

Rochester, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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bioMérieux Medical Affairs

Role: CONTACT

Phone: +33 4 78 87 20 00

Email: [email protected]

Facility Contacts

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Linda PAPA, MD

Role: primary

Linda PAPA, MD

Role: backup

Robert D. WELCH, MD

Role: primary

Role: backup

Neha RAUKAR

Role: primary

Role: backup

Neha RAUKAR, MD

Role: backup

Stacey House, MD

Role: primary

Stacey HOUSE, MD

Role: backup

Kian MERCHANT BORNA, MD

Role: primary

Jeffrey J BAZARIAN, MPH, MD

Role: backup

Kian MERCHANT BORNA, MD

Role: backup

Other Identifiers

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BM-2023-12

Identifier Type: -

Identifier Source: org_study_id