Blood test to guide head CT decisions after mild head injury
Biomarker Role in Assessing Imaging Needs for Mild Cranial Trauma
This project will test whether a rapid blood test can help doctors decide if adults with mild head injuries need a head CT scan.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT06932588 on ClinicalTrials.gov |
What this trial studies
The study enrolls adults who present to the emergency department within 24 hours of a mild traumatic brain injury and collects a blood sample for an Alinity whole-blood TBI biomarker measured by i-STAT. Treating clinicians are randomized to either receive the biomarker results to guide CT use or remain blinded to the results, and subsequent imaging decisions and outcomes are compared. Primary outcomes include whether access to biomarker data reduces head CT use, with secondary analyses of length of stay, costs, and prediction of clinical deterioration. The study will also develop and validate predictive models and identify patient subgroups where biomarker-guided imaging is most useful.
Who should consider this trial
Good fit: Adults aged 18 or older who present to the ED within 24 hours of a mild head injury (GCS 13–15), have not had prior head imaging for the incident, and are not pregnant, incarcerated, wards of the state, or cognitively impaired are ideal candidates.
Not a fit: Patients with penetrating head injuries, recent brain surgery or known brain abnormalities, those needing emergent surgical or stabilization procedures, or patients judged at high risk for decline are excluded and would not benefit from this biomarker-guided approach.
Why it matters
Potential benefit: If successful, this approach could safely reduce unnecessary head CT scans, lowering radiation exposure, emergency department wait times, and healthcare costs.
How similar studies have performed: Prior research using blood biomarkers such as GFAP and UCH-L1 has shown promise for ruling out intracranial injury and reducing CT use, but real-world randomized trials of biomarker-guided imaging in busy EDs remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Atlanta, Georgia
- Grady Health System — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Jonathan Grossberg, MD — Emory University
- Study coordinator: Ali Tfaily, MS
- Email: ali.tfaily@emory.edu
- Phone: 404-616-1000
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.