Blood Test for Concussions

Recruiting at 5 trial locations

Overseen By Linda PAPA, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: BioMérieux

Disqualifiers: Neurological disorders, Cancer, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

900 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve how doctors decide if a CT scan is needed for people with mild head injuries. It focuses on a new blood test, VIDAS® TBI, which detects specific proteins in the blood that appear after a brain injury. This test could quickly and easily determine the need for further scans. People who have had a mild head injury, are in the emergency room within 12 hours of the injury, and are already getting a CT scan might be a good fit for this trial. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance emergency care for head injuries.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the VIDAS® TBI Test is safe for use in patients with mild traumatic brain injury?

Research has shown that the VIDAS® TBI test is a blood test that detects two proteins, GFAP and UCH-L1, which appear in the blood after a brain injury. These proteins help doctors assess the severity of a brain injury following a mild head injury.

The FDA has approved this test, deeming it safe and effective. Doctors use it to determine if a CT scan is necessary for patients with mild brain injuries.

This approval and its application in real-world settings demonstrate that the test is generally safe and rarely causes harmful side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The VIDAS® TBI Test is unique because it offers a quick and non-invasive way to detect concussions through a simple blood test. Unlike traditional methods that rely heavily on neurological exams and CT scans, this test measures specific biomarkers, GFAP and UCH-L1, which are released into the bloodstream after a mild traumatic brain injury. Researchers are excited because this test could provide rapid and accurate diagnosis, potentially reducing the need for more costly and time-consuming imaging procedures.

What evidence suggests that the VIDAS® TBI Test is effective for assessing mild traumatic brain injury?

Research shows that the VIDAS® TBI test, which participants in this trial will undergo, can help detect brain injuries by measuring two proteins, GFAP and UCH-L1, in the blood. When someone experiences a mild traumatic brain injury, the levels of these proteins increase. This helps doctors quickly determine if a CT scan is needed. One study showed that the test correctly identified most brain injuries, missing only four out of 120 cases. The FDA has approved the test, allowing its use alongside other medical information to decide if further imaging is necessary. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals who have experienced a mild traumatic brain injury (mTBI), commonly known as a concussion, and are being evaluated in an Emergency Department. Specific eligibility criteria details were not provided.

Inclusion Criteria

I expect to be in the emergency department or ward for at least 2 hours.

Subject with signed Informed Consent Form (ICF)

I can provide a blood sample within 12 hours of my injury.

Exclusion Criteria

Time of injury unknown

Special populations, including women with known pregnancy, prisoners, or institutionalized individuals

I currently have active cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Assessment

Subjects presenting to the ED within 12 hours of suspected mild head trauma undergo blood collection for VIDAS® TBI testing

Immediate

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the initial assessment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• VIDAS® TBI Test

Trial Overview The study is testing the VIDAS® TBI Test, which measures two biomarkers in the blood—GFAP and UCH-L1—to help decide if patients with mTBI need a CT scan. The goal is to see how well this test works in a real-world emergency setting.

How Is the Trial Designed?

Group I: Subjects with Mild Traumatic Brain injury Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

BioMérieux

Lead Sponsor

Trials

62

Recruited

43,500+

Pierre Boulud

BioMérieux

Chief Executive Officer since 2023

Degree in Biology from Lyon I University, Graduate of HEC Montreal Business School

Dr. Charles K. Cooper

BioMérieux

Chief Medical Officer since 2024

MD from Georgetown University School of Medicine, Specialized in Infectious Diseases and Epidemiology at University of Maryland, Baltimore

Published Research Related to This Trial

The new rapid blood test measuring GFAP and UCH-L1 showed a high sensitivity of 95.8% for predicting acute traumatic intracranial injury (TII) in patients with mild traumatic brain injury, based on a study of 1918 subjects.

This test's speed and portability, along with its accuracy, suggest it could be a valuable tool in emergency departments for making decisions about head CT scans, potentially improving patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of a rapid glial fibrillary acidic protein/ubiquitin carboxyl-terminal hydrolase L1 test for the prediction of intracranial injuries on head computed tomography after mild traumatic brain injury. Bazarian, JJ., Welch, RD., Caudle, K., et al.[2022]

Screening for blunt cerebrovascular injuries (BCVI) is important, and institutions should establish formal criteria for screening, as broader criteria can lead to higher detection rates of injuries.

Noninvasive diagnostic methods like duplex ultrasonography and computed tomographic angiography are useful but may not be as accurate as arteriography, highlighting the need for careful selection of diagnostic tools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnosis of blunt cerebrovascular injuries. Biffl, WL.[2019]

Blunt cerebrovascular injuries (BCVI) are increasingly recognized, highlighting the importance of screening protocols after severe traumatic brain injuries (TBI).

The case presented involves a rupture of the anterior cerebral artery with free contrast extravasation, emphasizing the potential severity of BCVI in TBI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-traumatic Anterior Cerebral Artery Rupture after a Severe Traumatic Brain Injury. Mathais, Q., Esnault, P., Joubert, C., et al.[2022]

The combination of GFAP and UCH-L1 biomarkers showed high sensitivity (100%) for detecting traumatic intracranial lesions in patients with mild to moderate traumatic brain injury (MTBI), indicating their potential effectiveness as a diagnostic tool alongside clinical decision rules.

The Canadian CT Head Rule (CCHR) demonstrated the highest specificity among the clinical decision rules tested, and when combined with GFAP, it provided the best overall diagnostic performance for identifying intracranial lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Glial and Neuronal Blood Biomarkers Compared With Clinical Decision Rules in Assessing the Need for Computed Tomography in Patients With Mild Traumatic Brain Injury. Papa, L., Ladde, JG., O'Brien, JF., et al.[2023]

In a study of 156 patients with isolated blunt vertebral artery injuries, the majority were treated with aspirin, which was found to be effective in preventing strokes, particularly in grade I and IV injuries.

The overall risk of stroke after cervical vertebral artery injury was low, with only three strokes occurring before treatment, indicating that immediate treatment may not be necessary for all patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blunt Traumatic Vertebral Artery Injuries: Incidence, Therapeutic Management, and Outcomes. Zeineddine, HA., King, N., Lewis, CT., et al.[2022]

A blood test combining UCH-L1 and GFAP biomarkers demonstrated high sensitivity (97.6%) and negative predictive value (99.6%) for detecting traumatic intracranial injuries in patients with suspected TBI, potentially reducing unnecessary head CT scans.

In a study of 1959 patients, the test accurately identified the majority of those without intracranial injuries, suggesting it could be a reliable tool in emergency departments to rule out the need for CT imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serum GFAP and UCH-L1 for prediction of absence of intracranial injuries on head CT (ALERT-TBI): a multicentre observational study. Bazarian, JJ., Biberthaler, P., Welch, RD., et al.[2022]

In a study of 584 trauma patients, GFAP was found to be a reliable biomarker for detecting mild to moderate traumatic brain injury (MMTBI) and traumatic intracranial lesions, with diagnostic accuracy improving over the first week after injury.

UCH-L1 showed its highest diagnostic accuracy shortly after injury, peaking at 8 hours, but was less effective than GFAP for longer-term assessments, indicating that both biomarkers have distinct roles in the diagnosis of TBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time Course and Diagnostic Accuracy of Glial and Neuronal Blood Biomarkers GFAP and UCH-L1 in a Large Cohort of Trauma Patients With and Without Mild Traumatic Brain Injury. Papa, L., Brophy, GM., Welch, RD., et al.[2022]

The ACE microchip device effectively analyzes plasma biomarkers like GFAP, Tau, and UCH-L1 in patients with minor traumatic brain injury (TBI), showing potential for distinguishing between TBI and non-TBI patients with moderate sensitivity and specificity.

Significant correlations were found between plasma levels of these biomarkers and post-concussive symptoms, such as sensitivity to noise and light, headaches, and cognitive issues, indicating their potential role in assessing TBI severity and recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plasma Biomarker for Post-concussive Syndrome: A Pilot Study Using an Alternating Current Electro-Kinetic Platform. Lewis, JM., Dhawan, S., Obirieze, AC., et al.[2020]

Blunt cerebrovascular injury (BCVI) occurs in 0.9% of patients with mild or moderate traumatic brain injury (mTBI) and is strongly associated with cervical spine fractures, which significantly increase the risk of both blunt carotid artery injury (BCAI) and blunt vertebral artery injury (BVAI).

While BCVI typically does not require invasive treatment, it is linked to a higher likelihood of stroke and worse outcomes, including increased mortality risk from BVAI, longer hospital stays, and more days on mechanical ventilation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk Factors and Outcomes Associated with Blunt Cerebrovascular Injury in Patients with Mild or Moderate Traumatic Brain Injury. Hoffman, H., Bunch, KM., Protas, M., et al.[2021]

In a study involving 74 participants with mild traumatic brain injury (mTBI) and 44 controls, plasma levels of IL-6, GFAP, and UCH-L1 were identified as effective biomarkers for diagnosing mTBI within 6 hours of injury, with IL-6 showing the highest accuracy (AUC 0.91).

The combination of IL-6 and GFAP provided the best diagnostic model for acute mTBI, suggesting that including IL-6 in biomarker panels could enhance the accuracy of mTBI diagnosis in adults under 50 years old.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of Acute and Subacute Blood Biomarkers to Assist Diagnosis in CT-Negative Isolated Mild Traumatic Brain Injury. Reyes, J., Spitz, G., Major, BP., et al.[2023]

In a study of 93 blunt cerebrovascular injuries (BCVIs), 39.8% did not meet current injury screening criteria, indicating that these criteria may miss significant cases, especially in severe motor vehicle collisions (MVCs).

BCVIs that did not meet screening criteria were associated with higher deceleration impacts (average delta-v of 51.00 km/hour) and more frequent use of safety devices, suggesting that expanding screening criteria to include severe MVC characteristics could improve detection of BCVIs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blunt Cerebrovascular Injury Screening Criteria Should Include Motor Vehicle Crash Characteristics. Farhat-Sabet, A., Lauerman, M., Chavez, A., et al.[2021]

A study involving 247 adults with head injuries found that serum concentrations of GFAP, S-100β, and UCH-L1 can help identify and classify the severity of mild traumatic brain injury (mTBI) within 6 hours of injury, with GFAP showing the highest positive predictive value.

While all three biomarkers were effective in distinguishing between mTBI and no mTBI, they were not reliable for excluding a concussion diagnosis, indicating that further assessment is needed even with positive biomarker results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of Serum Biomarkers in the Diagnosis and Stratification of Mild Traumatic Brain Injury. Lewis, LM., Schloemann, DT., Papa, L., et al.[2022]

Citations

1. biomerieux.com biomerieux.com/corp/en/our-offer/clinical-products/vidas-tbi-gfap-uch-l1.html

VIDAS® TBI (GFAP, UCH-L1) - bioMerieux Fast all-in-one test kit based on blood-based brain biomarkers to predict absence of intracranial lesions in mild Traumatic Brain Injury patients.

2. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/K240279.pdf

A 510(k) Number K240279 B Applicant bioM Of the 120 subjects with positive CT scan results, four had negative results from the VIDAS. TBI (GFAP UCH-L1) test. The rate of false negative (FN) results was ...

3. tandfonline.com tandfonline.com/doi/full/10.1080/14737159.2024.2306876

The game changer: UCH-L1 and GFAP-based blood test ... The study explores how UCH-L1 and GFAP levels increase significantly in the bloodstream following traumatic brain injury, aiding in early and accurate diagnosis ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38275158/

The game changer: UCH-L1 and GFAP-based blood test ... The study explores how UCH-L1 and GFAP levels increase significantly in the bloodstream following traumatic brain injury, aiding in early and accurate ...

5. biomerieux.com biomerieux.com/us/en/journalists/press-releases/vidas-tbi-fda-clearance.html

bioMérieux receives FDA 510(k) clearance of VIDAS® TBI ... When used in conjunction with clinical information, VIDAS® TBI (GFAP, UCH-L1) results can aid clinicians in determining the need for CT imaging ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11647500/

An automated blood test for glial fibrillary acidic protein (GFAP ... The combined GFAP and UCH-L1 test, using the cutoff values suggested by the ALERT-TBI study, was able to rule out the need of CT scan in a cohort of 1438 adult ...

7. biomerieux.com biomerieux.com/us/en/journalists/press-releases/CE-marking-vidas-TBI.html

bioMérieux announces CE-marking of VIDAS® TBI (GFAP ... VIDAS® TBI (GFAP, UCH-L1) measures the concentration of GFAP and UCH-L1*, two brain biomarkers that are released into the bloodstream starting ...