Blood Test for Concussions

Recruiting at 4 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: BioMérieux

Disqualifiers: Neurological disorders, Cancer, Pregnancy, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment VIDAS® TBI Test for concussions?

The VIDAS® TBI Test, which measures GFAP and UCH-L1 levels, is effective in predicting brain injuries after a mild traumatic brain injury, as it has been shown to accurately detect intracranial injuries and reduce unnecessary CT scans. ^{1 2 3 4 5}

Is the blood test for concussions safe for humans?

The blood test using GFAP and UCH-L1 proteins has been approved by the FDA for detecting brain injuries, indicating it has undergone safety evaluations. However, specific safety data for humans is not detailed in the available research articles. ^{1 2 3 6 7}

Is the treatment in the trial 'Blood Test for Concussions' a promising treatment?

The treatment in the trial 'Blood Test for Concussions' seems promising because it could help identify injuries to important blood vessels in the brain after a concussion. This could lead to better care and outcomes for people with head injuries. ^{8 9 10 11 12}

Eligibility Criteria

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 have a neurological condition like dementia, Parkinson's, or MS.

Trial Timeline

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

Treatment Details

Interventions

• VIDAS® TBI Test (Biomarker 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.

Participant Groups

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

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

References

1. United States 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. [2022]

2. United States 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. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Utility of Serum Biomarkers in the Diagnosis and Stratification of Mild Traumatic Brain Injury. [2022]

4. England 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. [2022]

5. United States 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Utility of Acute and Subacute Blood Biomarkers to Assist Diagnosis in CT-Negative Isolated Mild Traumatic Brain Injury. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Plasma Biomarker for Post-concussive Syndrome: A Pilot Study Using an Alternating Current Electro-Kinetic Platform. [2020]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Risk Factors and Outcomes Associated with Blunt Cerebrovascular Injury in Patients with Mild or Moderate Traumatic Brain Injury. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Diagnosis of blunt cerebrovascular injuries. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Blunt Cerebrovascular Injury Screening Criteria Should Include Motor Vehicle Crash Characteristics. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Blunt Traumatic Vertebral Artery Injuries: Incidence, Therapeutic Management, and Outcomes. [2022]

12. India pubmed.ncbi.nlm.nih.gov

Post-traumatic Anterior Cerebral Artery Rupture after a Severe Traumatic Brain Injury. [2022]