i-STAT TBI Test for Traumatic Brain Injury

Recruiting at 2 trial locations

Overseen By Jonathan Schimmel, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Stroke, Skull fracture, Multiple sclerosis, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

450 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the i-STAT TBI Test, a new blood test, can help doctors decide whether people with mild traumatic brain injuries (TBI) need a CT scan. The blood test detects specific proteins linked to brain injury, potentially reducing unnecessary scans. Participants will have doctors who either use the blood test results or do not (serving as a control). This trial suits adults who have experienced a mild head injury within the last 24 hours and are awaiting a CT scan. As an unphased trial, it offers participants the opportunity to contribute to innovative research that could enhance future diagnostic processes.

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 the i-STAT TBI Test is safe for use in clinical settings?

Studies have shown that the i-STAT TBI test helps doctors quickly assess patients with mild traumatic brain injury (mTBI). This test uses a blood sample to detect specific proteins related to brain injury and provides results in about 15 minutes. Research suggests it can reduce unnecessary CT scans by identifying patients who may not need them.

The i-STAT TBI test, a blood test, is generally easy to handle and common in medical settings, with minimal risks such as slight discomfort or bruising at the needle site. It is approved for use in adults with mild TBI to help determine the need for a CT scan, indicating its safety. While no specific problems have been reported with the test, it serves as a decision-making tool rather than a treatment, further minimizing any risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the i-STAT TBI Test for traumatic brain injury because it offers a rapid, blood-based diagnostic approach, unlike standard imaging methods like CT scans. This test provides results quickly, potentially speeding up decision-making in emergency departments. By delivering immediate insights into a patient's condition, it could revolutionize how clinicians assess and manage head injuries, leading to more personalized and timely care.

What evidence suggests that the i-STAT TBI Test is effective for reducing unnecessary CT scans in mild TBI?

Research shows that the i-STAT TBI test could revolutionize the diagnosis of mild traumatic brain injuries (TBIs). Studies have found that it checks important substances in the blood, like GFAP and UCH-L1, which indicate brain injury. These substances help doctors decide if a head CT scan is needed. The test reliably rules out serious brain injuries with 99.4% accuracy. Previous research suggests it could reduce unnecessary CT scans by up to 40%, saving money and reducing radiation exposure. In this trial, participants in the Notification Arm will receive the i-STAT TBI test results to aid in clinical decision-making, making it a promising tool for doctors when deciding if more imaging is necessary. ^{1 2 3 4 5}

Who Is on the Research Team?

Shameeke Taylor, MD, MPH, MSCR

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for adults who've had a mild traumatic brain injury (TBI) within the last 24 hours. The goal is to see if a new blood test can help decide whether they need a head CT scan in the emergency department, potentially reducing unnecessary radiation exposure and healthcare costs.

Inclusion Criteria

Glasgow Coma Scale (GCS) 13 - 15

Head injury within 24 hours of research blood collection

CT head ordered as part of routine care, not yet completed

Exclusion Criteria

I don't know if I had a head injury, and I show no signs of one.

I have been diagnosed with multiple sclerosis.

Previously enrolled in this study in the past 30 days

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive the i-STAT TBI biomarker test to aid in clinical decision making for head CT imaging

1 day

1 visit (in-person)

Follow-up

Participants are monitored for outcomes such as head CT scan cancellations and ED length of stay

14 days

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• i-STAT TBI Test

Trial Overview The i-STAT TBI Test measures specific proteins in the blood that could indicate brain damage after a mild TBI. This study will evaluate how well this test works in real-world settings and if it can reliably reduce the number of CT scans needed.

How Is the Trial Designed?

Group I: Notification Arm (Abbott iSTAT TBI test) Experimental Treatment 1 Intervention

The ED clinicians caring for the enrolled patient, along with the patient, receive the TBI blood test result with just-in-time education on the TBI test to aid in clinical decision making.

Group II: Non-Notification Arm (Control) Active Control 1 Intervention

Clinicians and enrolled patients do not receive the TBI blood test result.

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Abbott Point of Care

Industry Sponsor

Trials

13

Recruited

10,200+

Published Research Related to This Trial

The Traumatic Brain Injury Screening Instrument (TBISI) was found to have poor test-retest reliability in a study of 44 OEF/OIF veterans, indicating inconsistencies in its ability to accurately identify mild TBI.

These preliminary findings highlight the need for further research into the TBISI's reliability and validity to ensure accurate screening and referral of veterans potentially suffering from traumatic brain injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Test-retest reliability of the Traumatic Brain Injury Screening Instrument. Van Dyke, SA., Axelrod, BN., Schutte, C.[2019]

The HeadSMART II study aims to create the BRAINBox TBI Test, which will use blood protein biomarkers and clinical assessments to provide objective diagnostics for acute traumatic encephalopathy (ATE) in patients with traumatic brain injury (TBI).

This multi-modal approach, involving serum biomarkers and neurocognitive testing, seeks to improve the identification of brain injuries and predict long-term outcomes, addressing the current lack of objective tests for TBI diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining Acute Traumatic Encephalopathy: Methods of the "HEAD Injury Serum Markers and Multi-Modalities for Assessing Response to Trauma" (HeadSMART II) Study. Peacock, WF., Kuehl, D., Bazarian, J., et al.[2021]

The study involved 200 active duty military personnel and found that those with diagnosed acute mild traumatic brain injury (mTBI) performed the King-Devick (KD) test approximately 36% slower than age-matched controls, indicating a significant difference in eye movement performance (p<0.001).

The results suggest that the KD test is a valid and efficient tool for screening acute mTBI, which is crucial for timely diagnosis and return-to-duty decisions for injured military personnel.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of the King-Devick® (KD) test for screening acute mTBI/concussion in warfighters. Walsh, DV., Capó-Aponte, JE., Beltran, T., et al.[2017]

The Mid-Atlantic Mental Illness Research, Education, and Clinical Center (MMA-TBI) Assessment has been shown to be a highly valid and reliable tool for evaluating traumatic brain injury (TBI) in post-deployment veterans, achieving a diagnostic correspondence of 96% for lifetime TBI and 92% for deployment-acquired TBI when compared to expert clinical evaluations.

The MMA-TBI demonstrated strong consistency with another validated TBI measure (OSU-TBI-ID), with a high agreement coefficient (κ = 0.90), indicating its effectiveness in standardizing TBI assessments according to VA/DoD clinical guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial Validation of the Mid-Atlantic Mental Illness Research, Education, and Clinical Center Assessment of Traumatic Brain Injury. Rowland, JA., Martindale, SL., Shura, RD., et al.[2023]

A study of 1274 patients with traumatic brain injury (TBI) showed that postacute rehabilitation significantly improved functioning, with 69% of patients achieving clinically meaningful gains.

The timing of rehabilitation after injury is crucial, as those treated within 0-3 months post-injury showed the greatest improvements, especially among patients with severe and moderate-to-severe impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment effect versus pretreatment recovery in persons with traumatic brain injury: a study regarding the effectiveness of postacute rehabilitation. Hayden, ME., Plenger, P., Bison, K., et al.[2013]

Citations

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

i-STAT TBI Cartridge The i-STAT TBI cartridge is the first point-of-care test that measures the level of biomarkers associated with brain injury in whole blood.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04171960

NCT04171960 | Clinical Evaluation of the i-STAT TBI Test The purpose of this study is to evaluate the clinical performance of the i-STAT TBI test for the proposed intended use; to assist in determining the need for a ...

3. 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 ...

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

Maximizing the Clinical Value of Blood-Based Biomarkers ... Clinicians can receive a reliable result from the test in 18 min, with a 99.4% negative predictive value. A blood test for a head injury would ...

5. globalpointofcare.abbott globalpointofcare.abbott/content/dam/ardx/globalpointofcare/apoc/5306-TBI-Sell-Sheet-v11.pdf

i-STAT TBI 1 The objective data this test provides helps assess patients with suspected mTBI. • Lab-quality results in just 15 minutes. •. Assists in making confident ...