Evaluation of the Abbott i-STAT TBI Biomarker Test
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: i-STAT TBI Test.
- Who it may be relevant to
- Registry conditions: Traumatic Brain Injury. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Device i-STAT TBI Test
The Abbott i-STAT TBI test result is shared with the enrolled patient and treating clinicians.
Primary outcome measures
- Number of Head CT scans canceled [Time frame: Within 24 hours of Traumatic Brain Injury]
Secondary outcome measures (9)
- Subset of Number of Head CT scans completed [Time frame: Within 24 hours of Traumatic Brain Injury]
- ED Length of Stay [Time frame: 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]
- Patient Satisfaction Scale [Time frame: At 14 days after ED visit]
- Number of head CT scans completed [Time frame: At 14 days after ED visit]
- Stress of Uncertainty Scale (SUS) [Time frame: Day 1 during patient ED care visit]
- Malpractice Fear Scale (MFS) Scores [Time frame: 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 of UCH-L1 (ubiquitin C-terminal hydrolase L1) [Time frame: Day 1 during patient ED care visit]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 3 centers
- Mount Sinai Morningside — New York
- Mount Sinai Hospital — New York
- Mount Sinai West — New York
Identifiers
NCT: NCT06766435 · STUDY-24-01057 · CRS-2024-001-257