Brain Injuries, Head Injury
Conditions
Keywords
Biomarkers, Brain imaging, Brain trauma, Head CT scan, Mild traumatic brain injury (mTBI)
Brief 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).
Detailed 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 improve the accuracy of these tests compared to CT scans. The study will enroll adults presenting with suspected mild traumatic brain injury (mTBI) in the emergency department at Grady Memorial Hospital. Minors, pregnant individuals, wards of the state, prisoners, and those with cognitive impairments will not be enrolled. Participants will undergo blood-based biomarker testing upon ED presentation. Healthcare providers will be randomly assigned to either be blinded to the biomarker results or receive the results to guide their decision on ordering head CT imaging.
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.
Sponsors
Emory University
Abbott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Caregiver)
Masking description
Healthcare providers will be randomly assigned to either be blinded to the biomarker results or receive the results to guide their decision on ordering head CT imaging.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 hemodynamic or orthopedic stabilization * Patients deemed at higher risk for decline by the provider prohibit the 15-minute delay in obtaining imaging needed for biomarker testing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants having a CT head scan from biomarker positive | During hospital admission (average 15 days). | The impact of biomarker results will be measured by the decision to obtain CT head imaging for patients presenting with mild TBI. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | Hospital admission (average 15) days. | Length of hospital stay until discharge |
| Number of participants with intracranial findings predicted by biomarker findings | Hospital admission (average 15) days. | In participants undergoing CT head imaging, the proportion of participants with intracranial findings between biomarker-positive and biomarker-negative groups will be compared. |
| Number of readmissions for TBI-related symptoms | up to 6 months after hospital discharge | Data will be taken from electronic medical records (EMR) and participant's interviews. |
| Glasgow Outcome Scale-Extended (GOS-E) | 6 and 12 months after hospital discharge | Functional outcome measured by the GOS-E. The Glasgow Outcome Scale-Extended (GOS-E) is one of the most widely used outcome instruments to assess global disability and recovery after traumatic brain injury. The patient's overall rating is based on the lowest outcome category indicated on the scale. The overall rating is the lowest outcome category indicated by the person's answers (after discounting limitations or problems before injury). Deaths are taken from records, and on the GOS-E rating schema, a vegetative state (VS) or a score of 2 is the lowest category, and Upper Good Recovery (Upper GR) or a score of 8 is the highest. If the person has no limitations or impaired symptoms, their GOS-E rating is Upper GR (8). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJonathan Grossberg, MD
Emory University
Outcome results
None listed