Biomarker Role in Assessing Imaging Needs for Mild Cranial Trauma
Emory University
Summary
This study aims to determine whether a blood test can help doctors decide when to use a head CT scan for patients with a mild head injury. Researchers are investigating whether the results from this blood test can aid in making better decisions about patient care and potentially reduce the need for imaging. In this study, researchers will collect blood samples to assess whether this specific blood test can help doctors decide when head imaging is necessary following a head injury. The goal is to determine whether the use of this test can reduce the number of head imaging procedures performed in the emergency department (ED).
Description
The Biomarker Role in Assessing Imaging Needs for Mild Cranial Trauma (BRAIN-CT) study aims to determine whether immediate access to blood biomarker data can help doctors decide when a CT scan is necessary for patients with mild traumatic brain injury (mTBI). The study will also explore how biomarker data influences clinical outcomes, such as hospital stay duration, costs, and recovery. Additionally, it will identify specific patient groups where biomarker results may alter imaging decisions, assess the ability of biomarkers to predict worsening symptoms and develop predictive models to improv…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Adults aged 18 years and older * Mild TBI, defined as Glasgow Coma Scale (GCS) score 13-15, presenting within 24 hours of injury * No prior head imaging for the same incident * Presenting within 24 hours of onset of injury Exclusion Criteria: * Patients with penetrating head injury * History of known brain abnormality including tumor, cerebrovascular malformation, recent brain surgery (within 6 months), prior head injury (within 6 months) * Need for emergent surgical intervention for brain or alternate body organ injury * Need for emergent bedside procedures for hemody…
Interventions
- Diagnostic TestBiomarker Testing using the Alinity Whole-blood TBI biomarker i-STAT
The i-STAT TBI cartridge is a point-of-care, whole-blood, biomarker-based assay that measures the level of biomarkers associated with brain injury in the bloodstream 24 hours after injury. Blood samples (5-10cc of whole blood) will be collected upon admission during a routine blood drawing in the ED. These samples will be tested using the iSTAT system for mild TBI biomarkers. In a subset of admitted patients, serial blood draws and iSTAT testing will be performed at 4, 8, 16, and 24 hours, depending on the patient's length of stay.
Location
- Grady Health SystemAtlanta, Georgia