Traumatic Brain InjuryNCT06766435
Evaluation of the Abbott i-STAT TBI Biomarker Test
A study testing i-STAT TBI Test in people with Traumatic Brain Injury, run by Icahn School of Medicine at Mount Sinai at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- i-STAT TBI Test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Jan 2025to 30 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Head injury within 24 hours of research blood collection
- CT head ordered as part of routine care, not yet completed.
- Glasgow Coma Scale (GCS) 13 - 15
Who cannot join
- Unknown whether head injury occurred, and signs of head injury are absent
- Previously enrolled in this study in the past 30 days
- Prisoner or in police custody or known pregnancy
- Suspected current ischemic or hemorrhagic stroke
- Suspected open or depressed skull fracture, or signs of skull base fracture
- History of multiple sclerosis
- Venipuncture not feasible
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mount Sinai Morningside
New York, New York, 10025
Mount Sinai Hospital
New York, New York, 10029
Mount Sinai West
New York, New York, 10029
About this study
Official title: Evaluation of the Abbott i-STAT TBI Biomarker Test for Effect on Decreasing CT Utilization Among Adult Emergency Department Patients With Suspected Traumatic Brain Injury
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.
- Conditions
- Traumatic Brain Injury
- Being tested
- i-STAT TBI Test
- Keywords
- Point of Care Testing, Emergency Care, Clinical Decision Making, Head Injury
- Medical subject headings
- Brain Injuries, Traumatic, Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
i-STAT TBI TestDevice
Also called Abbott iSTAT Alinity
The Abbott i-STAT TBI test result is shared with the enrolled patient and treating clinicians.
| Study group | Role | What they receive |
|---|---|---|
| Notification Arm (Abbott iSTAT TBI test) | Experimental | 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. Receives: Device: i-STAT TBI Test |
| Non-Notification Arm (Control) | No intervention | Clinicians and enrolled patients do not receive the TBI blood test result. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Head CT scans canceled
Number of head CTs canceled in patients not on anticoagulants as measurement of percentage of reduction in the number of canceled head CTs out of total head CTs ordered (total number and percentage)
Measured: Within 24 hours of Traumatic Brain Injury
Secondary outcomes (9)
Subset of Number of Head CT scans completed
If the i-STAT TBI test results had been strictly adhered to by clinicians, subset of negative i-STAT TBI test results, Potential reduction in the number of completed head CTs (canceled) out of total head CTs ordered (total number and percentage)
Measured: Within 24 hours of Traumatic Brain Injury
ED Length of Stay
Length of stay for the Emergency Department patient encounter
Measured: Day 1 after patient ED care visit has ended
Number of cancellations of head CT scan order in patients on anticoagulants
Number of cancellations in head CTs in patients on anticoagulation
Measured: Day 1 after patient ED care visit has ended
Patient Satisfaction Scale
Assessment of patient satisfaction with care during ED visit. Full scale from 1 (worst care possible) to 10 (best care possible)
Measured: At 14 days after ED visit
Number of head CT scans completed
Number of head CT scans completed for patients within 14 days after index ED visit
Measured: At 14 days after ED visit
Stress of Uncertainty Scale (SUS)
Clinicians vary in their use of diagnostic testing and treatments, and stress of uncertainty may be one explanation for this variation. The stress of uncertainty scale measures clinician tolerance of uncertainty during patient care. SUS scores range from 15-90 with a higher score indicating greater fear of uncertainty.
Measured: Day 1 during patient ED care visit
Malpractice Fear Scale (MFS) Scores
Malpractice Fear Scale (MFS) scores. MFS scores range from 6 to 36 with a higher score indicating greater fear of malpractice.
Measured: Day 1 during patient ED care visit
Whole blood concentrations of GFAP (glial fibrillary acidic protein)
Whole blood concentrations for GFAP on the iSTAT device. Biomarker for use with mild TBI within 24 hours of injury to aid in determining the need for head CT imaging.
Measured: Day 1 during patient ED care visit
Whole blood concentrations of UCH-L1 (ubiquitin C-terminal hydrolase L1)
Whole blood concentrations for UCH-L1 on the iSTAT device. Biomarker for use with mild TBI within 24 hours of injury to aid in determining the need for head CT imaging.
Measured: Day 1 during patient ED care visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start30 Jan 2025
- Primary completion30 Mar 2026
- Study completion30 May 2026
Why it stopped: Study was terminated early due to recruitment limitations and available funding for continued recruitment and follow up
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multisite randomized controlled clinical trial
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Point of Care
- Responsible party
- Principal investigator, Shameeke Taylor, Icahn School of Medicine at Mount Sinai
- Investigators
- Shameeke Taylor, MD, MPH, MSCR, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06766435
- Sponsor's protocol ID
- STUDY-24-01057
- Other IDs
- CRS-2024-001-257
- Status last verified
- Oct 2025
- First submitted
- 4 Jan 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to share IPD at this time.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Abbott i-STAT TBI Biomarker Test for Effect on Decreasing CT Utilization Among Adult Emergency Department Patients With Suspected Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT06766435
- Acronym / sponsor ID
- STUDY-24-01057
- Conditions
- Traumatic Brain Injury
- Keywords
- Point of Care Testing, Emergency Care, Clinical Decision Making, Head Injury
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated early due to recruitment limitations and available funding for continued recruitment and follow up
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Abbott Point of Care
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multisite randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Notification Arm (Abbott iSTAT TBI test) | Experimental | Device: i-STAT TBI TestThe 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. |
| Non-Notification Arm (Control) | No intervention | –Clinicians and enrolled patients do not receive the TBI blood test result. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years
- Head injury within 24 hours of research blood collection
- CT head ordered as part of routine care, not yet completed.
- Glasgow Coma Scale (GCS) 13 - 15
Key exclusion criteria (7 listed)
- Unknown whether head injury occurred, and signs of head injury are absent
- Previously enrolled in this study in the past 30 days
- Prisoner or in police custody or known pregnancy
- Suspected current ischemic or hemorrhagic stroke
- Suspected open or depressed skull fracture, or signs of skull base fracture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| i-STAT TBI TestAlso: Abbott iSTAT AlinityThe Abbott i-STAT TBI test result is shared with the enrolled patient and treating clinicians. | Device | Notification Arm (Abbott iSTAT TBI test) |
Primary outcome
Number of Head CT scans canceled
Time frame: Within 24 hours of Traumatic Brain Injury
Number of head CTs canceled in patients not on anticoagulants as measurement of percentage of reduction in the number of canceled head CTs out of total head CTs ordered (total number and percentage)
9 secondary outcomes
Subset of Number of Head CT scans completed
Time frame: Within 24 hours of Traumatic Brain Injury
ED Length of Stay
Time frame: Day 1 after patient ED care visit has ended
Number of cancellations of head CT scan order in patients on anticoagulants
Time frame: Day 1 after patient ED care visit has ended
Patient Satisfaction Scale
Time frame: At 14 days after ED visit
Number of head CT scans completed
Time frame: At 14 days after ED visit
Stress of Uncertainty Scale (SUS)
Time frame: Day 1 during patient ED care visit
Malpractice Fear Scale (MFS) Scores
Time frame: Day 1 during patient ED care visit
Whole blood concentrations of GFAP (glial fibrillary acidic protein)
Time frame: Day 1 during patient ED care visit
Whole blood concentrations of UCH-L1 (ubiquitin C-terminal hydrolase L1)
Time frame: Day 1 during patient ED care visit
Results and safety
The study was stopped early (reason given: Study was terminated early due to recruitment limitations and available funding for continued recruitment and follow up). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No. There is no plan to share IPD at this time.
Related trials for Traumatic Brain Injury
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shameeke Taylor, MD, MPH, MSCR principal investigator
Icahn School of Medicine at Mount Sinai
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing i-STAT TBI Test in people with Traumatic Brain Injury, run by Icahn School of Medicine at Mount Sinai at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study was terminated early due to recruitment limitations and available funding for continued recruitment and follow up). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Head CT scans canceled (time frame: Within 24 hours of Traumatic Brain Injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.