Evaluation of a blood test for traumatic brain injury
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
NA · Icahn School of Medicine at Mount Sinai · NCT06766435
This study is testing a new blood test to see if it can help doctors quickly diagnose mild traumatic brain injuries in adults who have recently had a head injury.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 450 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai (other) |
| Drugs / interventions | radiation |
| Locations | 3 sites (New York, New York and 2 other locations) |
| Trial ID | NCT06766435 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the Abbott i-STAT TBI biomarker test, which measures specific proteins in the blood to aid in the diagnosis of traumatic brain injury (TBI). The test aims to provide a quicker and more efficient alternative to traditional head CT scans, particularly for patients with mild TBI. By using the i-STAT Alinity instrument, the study seeks to improve clinical decision-making in emergency care settings. Participants will be adults who have sustained a head injury within the last 24 hours and are awaiting a CT scan as part of their routine care.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have experienced a head injury within the last 24 hours and have a Glasgow Coma Scale score between 13 and 15.
Not a fit: Patients who have signs of severe head injury, such as suspected stroke or skull fractures, may not benefit from this study.
Why it matters
Potential benefit: If successful, this test could reduce unnecessary CT scans, decrease emergency department wait times, and minimize radiation exposure for patients with mild TBI.
How similar studies have performed: Other studies have shown promise in using biomarker tests for TBI diagnosis, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New York, New York and 2 other locations
- Mount Sinai Morningside — New York, New York, United States (RECRUITING)
- Mount Sinai Hospital — New York, New York, United States (RECRUITING)
- Mount Sinai West — New York, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Shameeke Taylor, MD, MPH, MSCR — Icahn School of Medicine at Mount Sinai
- Study coordinator: Mitali Pradhan, MS, CCRP
- Email: Mitali.Pradhan@mountsinai.org
- Phone: 201-423-3585
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Traumatic Brain Injury, Point of Care Testing, Emergency Care, Clinical Decision Making, Head Injury