Biomarker Testing for Head Trauma

(BRAIN-CT Trial)

Overseen By Ali Tfaily, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Penetrating head injury, Brain abnormality, others

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

Compensation: Varies

Number of Visits: 1

350 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Alinity Whole-blood TBI biomarker i-STAT for head trauma?

Research shows that certain blood-based biomarkers can help identify brain injuries that might not be visible on standard imaging tests like CT scans. This suggests that using blood tests to detect these biomarkers could be a useful tool in managing mild traumatic brain injuries. ^{1 2 3 4 5}

How is the Alinity Whole-blood TBI biomarker i-STAT treatment different from other treatments for head trauma?

The Alinity Whole-blood TBI biomarker i-STAT is unique because it uses blood biomarkers to help diagnose and manage traumatic brain injuries (TBIs), potentially reducing the need for imaging tests like CT scans. This approach focuses on identifying specific proteins in the blood that are linked to brain injury, offering a more immediate and less invasive method compared to traditional imaging techniques. ^{1 2 6 7 8}

What is the purpose of this trial?

This study aims to determine whether a blood test can help doctors decide when to use a head CT scan for patients with a mild head injury. Researchers are investigating whether the results from this blood test can aid in making better decisions about patient care and potentially reduce the need for imaging. In this study, researchers will collect blood samples to assess whether this specific blood test can help doctors decide when head imaging is necessary following a head injury. The goal is to determine whether the use of this test can reduce the number of head imaging procedures performed in the emergency department (ED).

Research Team

Jonathan Grossberg, MD

Principal Investigator

Emory University

Eligibility Criteria

This trial is for patients who have suffered a mild head injury, such as from an unintentional home accident. To participate, individuals must be in need of evaluation for potential traumatic brain injury but not require immediate surgery.

Inclusion Criteria

No prior head imaging for the same incident

My injury occurred within the last 24 hours.

I had a mild head injury and was mostly alert afterwards.

Exclusion Criteria

Patients with penetrating head injury

I need urgent surgery for a brain or other organ injury.

Patients deemed at higher risk for decline by the provider prohibit the 15-minute delay in obtaining imaging needed for biomarker testing

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Biomarker Testing

Participants undergo blood-based biomarker testing upon ED presentation to assess the need for head CT imaging

During hospital admission

1 visit (in-person)

Hospital Admission

Participants are monitored for clinical outcomes such as hospital stay duration and recovery

Average 15 days

Follow-up

Participants are monitored for functional outcomes and re-admission for TBI-related symptoms

6 months after hospital discharge

Treatment Details

Interventions

• Alinity Whole-blood TBI biomarker i-STAT

Trial Overview The study is testing the effectiveness of a blood test using the Alinity Whole-blood TBI biomarker i-STAT to determine if it can guide doctors on when to perform a CT scan after mild cranial trauma.

Participant Groups

Group I: Published Biomarker Group Experimental Treatment 1 Intervention

Biomarker results are provided to the ED provider immediately and before the decision to order a head CT is made. A print-out of the results will be handed to the provider or uploaded to the epic platform.

Group II: Blinded Biomarker Group Active Control 1 Intervention

Biomarker results are not disclosed during the decision-making process for cranial imaging.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Abbott

Industry Sponsor

Trials

760

Recruited

489,000+

Dr. Etahn Korngold

Abbott

Chief Medical Officer

MD, Harvard Medical School

Robert B. Ford

Abbott

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business

References

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

Glial fibrillary acidic protein elevations relate to neuroimaging abnormalities after mild TBI. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Higher exosomal tau, amyloid-beta 42 and IL-10 are associated with mild TBIs and chronic symptoms in military personnel. [2019]

3. India pubmed.ncbi.nlm.nih.gov

Correlation of ubiquitin C terminal hydrolase and S100β with cognitive deficits in young adults with mild traumatic brain injury. [2019]

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

Exosomal neurofilament light: A prognostic biomarker for remote symptoms after mild traumatic brain injury? [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Determining the value of early measurement of interleukin-10 in predicting the absence of brain lesions in CT scans of patients with mild traumatic brain injury. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Blood Biomarkers for Traumatic Brain Injury: A Quantitative Assessment of Diagnostic and Prognostic Accuracy. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Can serum biomarkers be used to rule out significant intracranial pathology in emergency department patients with mild traumatic brain injury? A Systemic Review & Meta-Analysis. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Blood Biomarkers in Moderate-To-Severe Traumatic Brain Injury: Potential Utility of a Multi-Marker Approach in Characterizing Outcome. [2022]