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NCT06766435 · ClinicalTrials.gov registry record · NA
Evaluation of the Abbott i-STAT TBI Biomarker Test
A NA study of Traumatic Brain Injury, sponsored by Icahn School of Medicine at Mount Sinai.
- Recruiting
- Registry status
- NA
- Development phase
- 450
- Enrollment target
- 3
- Study locations
NCT06766435: Recruiting NA study of Traumatic Brain Injury, sponsored by Icahn School of Medicine at Mount Sinai.
NCT06766435 is a NA study of Traumatic Brain Injury that is actively recruiting participants, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 450 participants, above the 275-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (64% higher). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06766435, a NA study of Traumatic Brain Injury, is actively recruiting participants, sponsored by Icahn School of Medicine at Mount Sinai.
- RECRUITING
- Registry status
- NA
- Development phase
- 450 participants
- Enrollment target
- 3
- Study locations
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.
Primary Outcome
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)
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 |
What NCT06766435 shows while recruiting
NCT06766435 is an interventional study that assigns participants to a tested intervention. The registered 450 participants enrollment target is mid-sized for trials with a published cap, above the 275-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (64% higher).
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.
NCT06766435 reports a single indexed study location in New York.
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.
What interventions are being tested in trial NCT06766435?
The interventions under investigation include: i-STAT TBI Test (DEVICE).
Who is sponsoring clinical trial NCT06766435?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT06766435's enrollment target sits among peer trials
450 16th of 171 higher than 156 of 171 other Traumatic Brain Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Traumatic Brain Injury trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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