Evaluation of the Abbott i-STAT TBI Biomarker Test

February 18, 2025 updated by: Shameeke Taylor, Icahn School of Medicine at Mount Sinai

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
450

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Notification Arm (Abbott iSTAT TBI test)
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.
Device: i-STAT TBI Test
The Abbott i-STAT TBI test result is shared with the enrolled patient and treating clinicians.
Other Names:
  • Abbott iSTAT Alinity
No Intervention: Non-Notification Arm (Control)
Clinicians and enrolled patients do not receive the TBI blood test result.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Within 24 hours of Traumatic Brain Injury

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Subset of Number of Head CT scans completed
Time Frame: Within 24 hours of Traumatic Brain Injury
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)
Within 24 hours of Traumatic Brain Injury
ED Length of Stay
Time Frame: Day 1 after patient ED care visit has ended
Length of stay for the Emergency Department patient encounter
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
Number of cancellations in head CTs in patients on anticoagulation
Day 1 after patient ED care visit has ended
Number of head CT scans completed
Time Frame: At 14 days after ED visit
Number of head CT scans completed for patients within 14 days after index ED visit
At 14 days after ED visit
Stress of Uncertainty Scale (SUS)
Time Frame: Day 1 during patient ED care visit
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.
Day 1 during patient ED care visit
Malpractice Fear Scale (MFS) Scores
Time Frame: Day 1 during patient ED care visit
Malpractice Fear Scale (MFS) scores. MFS scores range from 6 to 36 with a higher score indicating greater fear of malpractice.
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 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.
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
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.
Day 1 during patient ED care visit
Patient Satisfaction Scale
Time Frame: At 14 days after ED visit
Assessment of patient satisfaction with care during ED visit. Full scale from 1 (worst care possible) to 10 (best care possible)
At 14 days after ED visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Icahn School of Medicine at Mount Sinai

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Abbott Point of Care

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shameeke Taylor, MD, MPH, MSCR, Icahn School of Medicine at Mount Sinai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 30, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 4, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY-24-01057
  • CRS-2024-001-257 (Other Grant/Funding Number: Abbott Point of Care)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share IPD at this time.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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