VIDAS® TBI Performance in Subjects With Mild Traumatic Brain Injury (mTBI)

Mild Traumatic Brain Injury Clinical Trial

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 Glascow Coma Scale (GCS) Between 13-15

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06449183
• Other study ID #: BM-2023-12
• Status: Recruiting
• Phase: N/A
• Start date: May 16, 2024
• Est. completion date: November 16, 2024

Study information

• Verified date: June 2024
• Source: BioMérieux
• Contact: bioMérieux Medical Affairs
• Phone: +33 4 78 87 20 00
• Email: clinicalstudies[@]biomerieux.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: November 16, 2024
• Est. primary completion date: August 16, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Mild Traumatic Brain Injury
• Wounds and Injuries

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
United States	Orlando Health	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
BioMérieux

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	to measure the percentage of CT-scan potentially avoided		3 months
Other	To estimate the biomarkers associated costs compared to the theoretical CT-scan associated costs		3 months
Other	To estimate the potentially associated costs saved by VIDAS® TBI use compared to the a theoretical CT-scan associated costs		3 months
Other	To estimate the biomarkers associated costs of Length of stay in Emergency Department (ED) compared to a theoretical CT-scan associated Length of stay in ED.		3 months
Other	To estimate the biomarkers associated costs of Length of stay in the hospital compared to a theoretical CT-scan associated Length of stay at hospital.		3 months
Other	To estimate the expected impact of the use of VIDAS® TBI on time to medical decision		3 months
Other	To estimate the expected impact of the use of VIDAS® TBI on patient stay in the ED		3 months
Other	To estimate the expected impact of the use of VIDAS® TBI on hospitalization decision rate		3 months
Other	To estimate the impact of the use of VIDAS® TBI on the time to discharge		3 months
Other	To estimate the impact of the use of VIDAS® TBI on the patient's monitoring duration		3 months
Primary	To determine VIDAS® TBI sensitivity to exclude the presence of an intracranial lesion		12 hours post mild brain trauma
Primary	To determine VIDAS® TBI specificity to exclude the presence of an intracranial lesion		12 hours post mild brain trauma
Primary	To determine VIDAS® TBI Positive Predictive Value to exclude the presence of an intracranial lesion		12 hours post mild brain trauma
Primary	To determine VIDAS® TBI Negative Predictive Value to exclude the presence of an intracranial lesion		12 hours post mild brain trauma
Primary	To determine VIDAS® TBI Positive Likelihood Ratio to exclude the presence of an intracranial lesion		12 hours post mild brain trauma
Primary	To assess VIDAS® TBI Negative Likelihood Ratio to exclude the presence of an intracranial lesion		12 hours post mild brain trauma
Secondary	To determine Canadian CT Head Rule sensitivity combined to VIDAS sensitivity to exclude the presence of an intracranial lesion		12 hours post mild brain trauma
Secondary	To determine Canadian CT Head Rule specificity combined to VIDAS specificity to exclude the presence of an intracranial lesion		12 hours post mild brain trauma
Secondary	To determine Canadian CT Head Rule Positive Predictive Value combined to VIDAS positive Predictive Value to exclude the presence of an intracranial lesion		12 hours post mild brain trauma
Secondary	To determine Canadian CT Head Rule Negative Predictive Value combined to VIDAS Negative Predictive Value to exclude the presence of an intracranial lesion		12 hours post mild brain trauma
Secondary	To determine Canadian CT Head Rule Positive Likelihood Ratio combined to VIDAS Positive Likelihood Ration to exclude the presence of an intracranial lesion		12 hours post mild brain trauma
Secondary	To determine Canadian CT Head Rule Negative Likelihood Ratio combined to VIDAS Negative Likelihood Ration to exclude the presence of an intracranial lesion		12 hours post mild brain trauma