RECRUITING

Evaluation of the Abbott i-STAT TBI Biomarker Test

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-01-30
Study Completion:2025-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06766435

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥18 years
  2. * Head injury within 24 hours of research blood collection
  3. * CT head ordered as part of routine care, not yet completed.
  4. * Glasgow Coma Scale (GCS) 13 - 15
  1. * Unknown whether head injury occurred, and signs of head injury are absent
  2. * Previously enrolled in this study in the past 30 days
  3. * Prisoner or in police custody or known pregnancy
  4. * Suspected current ischemic or hemorrhagic stroke
  5. * Suspected open or depressed skull fracture, or signs of skull base fracture
  6. * History of multiple sclerosis
  7. * Venipuncture not feasible

Contacts and Locations

Study Contact

Mitali Pradhan, MS, CCRP
CONTACT
201-423-3585
Mitali.Pradhan@mountsinai.org
Jonathan Schimmel, MD
CONTACT
jonathan.schimmel@mountsinai.org

Principal Investigator

Shameeke Taylor, MD, MPH, MSCR
PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

Mount Sinai Morningside
New York, New York, 10025
United States
Mount Sinai Hospital
New York, New York, 10029
United States
Mount Sinai West
New York, New York, 10029
United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

  • Shameeke Taylor, MD, MPH, MSCR, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2025-01-30
Study Completion Date2025-10

Study Record Updates

Study Start Date2025-01-30
Study Completion Date2025-10

Terms related to this study

Keywords Provided by Researchers

  • Point of Care Testing
  • Emergency Care
  • Clinical Decision Making
  • Head Injury

Additional Relevant MeSH Terms

  • Traumatic Brain Injury