Biomarker role in assessing imaging needs for mild cranial trauma (BRAIN-CT): study protocol for a single-center, randomized controlled trial.
Ali Tfaily, Ariana Chacon, Tianwen Ma...
https://pubmed.ncbi.nlm.nih.gov/41586091Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06932588
Biomarker Role in Assessing Imaging Needs for Mild Cranial Trauma
Led by Emory University · Updated on 2025-12-15
350
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
A
Abbott
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating whether a blood test can help doctors decide when to use a head CT scan for patients with mild traumatic brain injury (mTBI). This study aims to assess if using biomarker data immediately upon emergency department (ED) presentation can reduce unnecessary head imaging, influence patient outcomes, and help develop better prediction models compared to CT scans alone. Adults with suspected mild head injury are the focus, excluding minors, pregnant individuals, prisoners, and those with cognitive impairments. Participants will have blood samples taken in the ED to measure biomarkers associated with brain injury using the Alinity Whole-blood TBI biomarker i-STAT system. Healthcare providers will be randomly assigned to either receive the biomarker results before deciding on head CT imaging or remain blinded to these results. Some admitted patients will also have additional blood draws at set intervals up to 24 hours. This randomized, double-blind study compares groups with and without biomarker information guiding imaging decisions. During their participation, patients will undergo routine blood draws and biomarker testing, with data collected on CT scan use, hospital stay length, intracranial findings, and readmissions over several months. Outcomes like the Glasgow Outcome Scale-Extended will be assessed 6 months after discharge. Overall, the study monitors the proportion of patients receiving head CT scans during hospital admission and evaluates clinical, economic, and recovery impacts, with an average hospital stay of about 15 days.
CONDITIONS
Brief Title
Biomarker Role in Assessing Imaging Needs for Mild Cranial Trauma
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years and older
- Mild traumatic brain injury with Glasgow Coma Scale score between 13 and 15
- Presenting within 24 hours of head injury onset
- No prior head imaging for the current injury
You will not qualify if you...
- Penetrating head injury
- Known brain abnormalities such as tumor or cerebrovascular malformation
- Recent brain surgery within 6 months
- Prior head injury within 6 months
- Need for emergency brain or other organ surgery
- Need for emergent bedside procedures for stabilization
- Deemed high risk for decline preventing delay for biomarker testing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Up to 24 hours
Participants undergo blood-based biomarker testing upon emergency department presentation to assess the need for head CT imaging.
1 visit (in-person) with possible additional serial blood draws at 4, 8, 16, and 24 hours depending on length of stay
Hospital Admission
Duration - Average 15 days
Participants are monitored during hospital admission to evaluate clinical outcomes including imaging decisions, length of stay, and intracranial findings.
Continuous monitoring during hospital stay
Follow-up
Duration - Up to 6 months after discharge
Participants are followed for up to 6 months after hospital discharge to assess recovery, readmissions, and long-term outcomes.
1 to 2 follow-up visits depending on recovery
Trial Site Locations
Total: 1 location
1
Grady Health System
Atlanta, Georgia, United States, 30303
Actively Recruiting
Loading map...
Research Team
A
Ali Tfaily, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here