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

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.

How does the i-STAT TBI Test treatment differ from other treatments for traumatic brain injury?

The i-STAT TBI Test is unique because it is designed to provide an objective assessment of traumatic brain injury (TBI) using a blood test, which can help identify brain injuries and predict post-concussive symptoms. This differs from traditional methods that rely on subjective reports of symptoms like loss of consciousness or confusion, offering a more precise and early diagnosis. ^{1 2 3 4 5}

What is the purpose of this trial?

According to the Centers for Disease Control and Prevention, approximately 200,000 hospitalizations occurred in 2020 related to Traumatic Brain Injury (TBI), which does not include many TBIs treated only in emergency departments, urgent care, primary care, or that are not evaluated by a clinician. Head CT is a critical component of care for severe TBI, however in mild TBI there is practice variation with a wider risk to benefit estimation for obtaining head CT imaging. Potential disadvantages of head CT include longer Emergency Department (ED) length of stay (LOS), higher costs, and diagnostic radiation exposure. The i-STAT TBI test is a panel of in vitro diagnostic immunoassays for the quantitative measurements of glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) in whole blood and a semi-quantitative interpretation of test results derived from these measurements, using the i-STAT Alinity instrument. This biomarker test is cleared for use in adults with mild TBI (Glasgow Coma Scale 13-15) within 24 hours of injury, to aid in determining the need for head CT imaging. Currently, CT head imaging for adults with suspected mild TBI is obtained based on clinicians' usual practice patterns and beliefs about patient expectations. Prior research has demonstrated the blood TBI test may reduce unnecessary CT scans by up to 40%, however the impact on head CT ordering has not yet been studied prospectively. It is important to understand the extent to which a negative TBI biomarker result empowers a clinician to cancel a previously ordered head CT. Given that adult patients with mild TBI often present to EDs, which have access to CT scanners, this is a key setting to assess real-world impact of the i-STAT TBI test on CT head utilization.

Research Team

Shameeke Taylor, MD, MPH, MSCR

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Assessment of the King-Devick® (KD) test for screening acute mTBI/concussion in warfighters. [2017]

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

Test-retest reliability of the Traumatic Brain Injury Screening Instrument. [2019]

3. Switzerland 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. [2021]

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

Initial Validation of the Mid-Atlantic Mental Illness Research, Education, and Clinical Center Assessment of Traumatic Brain Injury. [2023]

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

Treatment effect versus pretreatment recovery in persons with traumatic brain injury: a study regarding the effectiveness of postacute rehabilitation. [2013]