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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a simple blood test (Alinity Whole-blood TBI biomarker i-STAT) can assist doctors in deciding when to use a head CT scan after a mild head injury. The goal is to reduce unnecessary imaging in the emergency room, ensuring scans are performed only when needed. Participants will have their blood tested to determine if this method enhances decision-making for head scans. The trial seeks individuals who experienced a mild head injury (feeling dazed or confused) within the last 24 hours and have not yet undergone a head scan for this injury. As an unphased trial, it offers participants the opportunity to contribute to innovative research that could improve emergency room practices.

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 prior data suggests that this blood test is safe for use in head trauma cases?

Research shows that the Alinity Whole-blood TBI biomarker i-STAT quickly provides lab-quality results for assessing mild traumatic brain injury (mTBI). People usually tolerate this blood test well, experiencing few negative side effects. Tests with blood samples from donors have proven it can provide reliable information without harming the person tested. However, the test does not predict long-term effects after a head injury. It primarily helps determine if immediate care, such as a CT scan, is necessary. Overall, evidence suggests the test is safe for use in people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Alinity Whole-blood TBI biomarker i-STAT because it offers a rapid and less invasive way to assess head trauma. Unlike the standard practice of using CT scans, which can expose patients to radiation and require more time, this biomarker test provides immediate results from a simple blood sample. This could allow healthcare providers to make quicker decisions about the need for further imaging, potentially reducing unnecessary scans and improving patient care.

What evidence suggests that this blood test is effective for deciding when to use a head CT scan for mild head injury?

Research has shown that the Alinity Whole-blood TBI biomarker i-STAT test can assist doctors in determining the necessity of a head CT scan after a mild head injury. This test detects specific proteins, GFAP and UCH-L1, released when the brain is injured. It delivers quick, accurate results at the patient's bedside in about 15 minutes. In this trial, participants in the Published Biomarker Group will have their biomarker results provided to the ED provider immediately, potentially reducing unnecessary CT scans, lowering radiation exposure, and speeding up care decisions. Meanwhile, participants in the Blinded Biomarker Group will not have their biomarker results disclosed during the decision-making process for cranial imaging. The FDA has approved this test, indicating trust in its ability to help evaluate brain injuries. ^{1 2 4 6 7}

Who Is on the Research Team?

Jonathan Grossberg, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. mountsinai.org mountsinai.org/clinical-trials/evaluation-of-abbott-stat-tbi-biomarker-test

Evaluation of the Abbott i-STAT TBI Biomarker Test Summary: According to the Centers for Disease Control and Prevention, approximately 200,000 hospitalizations occurred in 2020 related to Traumatic Brain ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10650880/

Maximizing the Clinical Value of Blood-Based Biomarkers ... Abbott's Alinity i TBI test may be beneficial in evaluating common biomarkers released upon brain injury such as GFAP and UCH-L1. The newfound ...

3. psychiatryonline.org psychiatryonline.org/doi/full/10.1176/appi.pn.2023.10.8.46

New Developments in Blood-Based Biomarkers for TBI Aggregate data from a new test administered after a traumatic brain injury could lead to the prevention of persistent symptoms and new drug treatments.

4. globalpointofcare.abbott globalpointofcare.abbott/us/en/product-details/apoc/istat-tbi.html

i-STAT TBI Cartridge The i-STAT TBI cartridge provides objective data to help assess patients with suspected mild traumatic brain injury (mTBI) and provides lab-quality results in ...

5. neurologylive.com neurologylive.com/view/fda-clears-abbott-i-stat-traumatic-brain-injury-whole-blood-test-bedside-assessment

FDA Clears Abbott's i-STAT Traumatic Brain Injury Whole ... The newly cleared i-STAT TBI test can be used to help assess patients up to 24 hours after injury at patient bedside, with lab-quality results produced in 15 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8469272/

The Current State of Traumatic Brain Injury Biomarker ... As of now the i-STAT Alinity TBI cartridge requires a plasma sample, but Abbott is working on a test that utilizes a whole blood sample, which would allow ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/K234143.pdf

K234143.pdf - accessdata.fda.gov The study was conducted using two lots of i-STAT TBI cartridges and i-STAT Alinity instruments. Whole blood samples from six donors were altered to target ...