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Evaluation of the Abbott i-STAT TBI Biomarker Test
NCT06766435 · View on ClinicalTrials.gov ↗
Study 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. 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 Studied
Interventions
- DEVICE i-STAT TBI Test
Study Locations (3)
New York
- Mount Sinai Morningside — New York
- Mount Sinai Hospital — New York
- Mount Sinai West — New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2025-01-30 |
| Est. Completion | 2025-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06766435
The ClinicalTrials.gov registry entry for NCT06766435 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 450 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 946 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Traumatic Brain Injury appearing as the primary indexed condition, and to 1 intervention — of which i-STAT TBI Test is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06766435 reports 3 study locations spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06766435 about?
NCT06766435 is a clinical study titled "Evaluation of the Abbott i-STAT TBI Biomarker Test". 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. H...
What is the current status of trial NCT06766435?
This trial is currently recruiting. It is a NA study. The enrollment target is 450 participants. The study started on 2025-01-30. Estimated completion is 2025-10.
What conditions does trial NCT06766435 study?
This clinical trial studies the following conditions: Traumatic Brain Injury. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06766435?
The interventions under investigation include: i-STAT TBI Test (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06766435?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 946 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06766435 being conducted?
This trial has 3 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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