Clinical trial NCT06449183: VIDAS® TBI Real Life Performance in Subjects with Mild Traumatic Brain Injury (mTBI)
Official title: Real-life Performance and Added Value of the VIDAS® TBI Blood Test in the Assessment of Mild Traumatic Brain Injury (mTBI), in Subjects with a Glasgow Coma Scale (GCS) Between 13-15
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Traumatic Brain Injury
Keywords: 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)
Lead sponsor: BioMérieux
Sponsor class: INDUSTRY
First posted: 2024-06-07
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Prospective Cohort. Multicentric, International clinical study.
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: To determine VIDAS® TBI sensitivity to exclude the presence of an intracranial lesion
timeFrame: 12 hours post mild brain trauma
measure: To determine VIDAS® TBI specificity to exclude the presence of an intracranial lesion
timeFrame: 12 hours post mild brain trauma
measure: To determine VIDAS® TBI Positive Predictive Value to exclude the presence of an intracranial lesion
timeFrame: 12 hours post mild brain trauma
measure: To determine VIDAS® TBI Negative Predictive Value to exclude the presence of an intracranial lesion
timeFrame: 12 hours post mild brain trauma
measure: To determine VIDAS® TBI Positive Likelihood Ratio to exclude the presence of an intracranial lesion
timeFrame: 12 hours post mild brain trauma
measure: To assess VIDAS® TBI Negative Likelihood Ratio to exclude the presence of an intracranial lesion
timeFrame: 12 hours post mild brain trauma
Secondary outcomes:
measure: To determine Canadian CT Head Rule specificity combined to VIDAS specificity to exclude the presence of an intracranial lesion
timeFrame: 12 hours post mild brain trauma
measure: To determine Canadian CT Head Rule sensitivity combined to VIDAS sensitivity to exclude the presence of an intracranial lesion
timeFrame: 12 hours post mild brain trauma
measure: To determine Canadian CT Head Rule Positive Predictive Value combined to VIDAS positive Predictive Value to exclude the presence of an intracranial lesion
timeFrame: 12 hours post mild brain trauma
measure: To determine Canadian CT Head Rule Negative Predictive Value combined to VIDAS Negative Predictive Value to exclude the presence of an intracranial lesion
timeFrame: 12 hours post mild brain trauma
measure: To determine Canadian CT Head Rule Negative Likelihood Ratio combined to VIDAS Negative Likelihood Ration to exclude the presence of an intracranial lesion
timeFrame: 12 hours post mild brain trauma
measure: To determine Canadian CT Head Rule Positive Likelihood Ratio combined to VIDAS Positive Likelihood Ration to exclude the presence of an intracranial lesion
timeFrame: 12 hours post mild brain trauma
measure: To estimate the impact of the use of VIDAS® TBI on the time to discharge
timeFrame: 3 months
measure: To estimate the expected impact of the use of VIDAS® TBI on patient stay in the ED
timeFrame: 3 months
measure: To estimate the expected impact of the use of VIDAS® TBI on hospitalization decision
timeFrame: 3 months
measure: To estimate the expected impact of the use of VIDAS® TBI on time to medical decision
timeFrame: 3 months
measure: To estimate the impact of the use of VIDAS® TBI on the patient's monitoring duration
timeFrame: 3 months
measure: to measure the percentage of CT-scan potentially avoided
timeFrame: 3 months
measure: To estimate the saving costs when using VIDAS® TBI in comparison with usual clinical sites' care.
timeFrame: 3 months
measure: To estimate the costs of Length of stay in Emergency Department (ED) when using VIDAS® TBI in comparison with usual clinical sites' care.
timeFrame: 3 months
measure: To estimate the associated costs of Length of stay in the hospital when using VIDAS® TBI in comparison with usual clinical sites' care.
timeFrame: 3 months
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Health
state: Florida
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
References: