Biomarkers plus guidelines to reduce unnecessary brain CTs after head injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pragmatic, open-label study uses a stepped-wedge design across six emergency departments to compare biomarker-guided pathways with guideline-only care for suspected traumatic brain injury. Biomarkers GFAP and UCH-L1 are used alongside clinical guidelines to decide whether a CT scan is needed. The study begins with usual care, then progressively implements the biomarker-guided algorithm at different sites over 24 months to assess real-world effectiveness and implementation feasibility. The primary focus is on reducing low-value CT imaging while maintaining patient safety. Eligible participants are adults 18 or older with suspected TBI and a GCS of 13-15 presenting within 24 hours of injury.

Why it matters

Who can join: the full rules

Inclusion

* Age ≥18 years at the time of the emergency department visit.
* Presentation to a participating emergency department following a traumatic injury mechanism (motor vehicle collision, fall from height, assault, head injury/head trauma/head strike, struck by or against an object, facial injury or laceration, or other general trauma). Presentations may also include alcohol intoxication or syncope when associated with a suspected traumatic brain injury.
* Evidence of potential head or brain injury, defined as (i) the head being struck by an object, (ii) the head striking a hard object or surface, (iii) exposure of the brain to significant acceleration/deceleration forces, or (iv) clinician documentation that the patient was evaluated for suspected traumatic brain injury.
* Glasgow Coma Scale (GCS) score of 13-15 at presentation.
* Presentation to the emergency department within 24 hours of injury.

Exclusion Criteria:

* Planned computed tomography (CT) imaging of the maxillofacial bones, chest, abdomen, or pelvis during the ED encounter AND clinicians do not intend to avoid brain CT imaging even if the biomarker test is negative.
* Current use of anticoagulant or antiplatelet therapy, including but not limited to: Warfarin, Factor Xa inhibitors (e.g., apixaban \[Eliquis\], rivaroxaban \[Xarelto\]), Clopidogrel, Ticagrelor.
* Presentation \>24 hours after injury, due to the declining diagnostic sensitivity of Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin Carboxy-terminal Hydrolase L1 (UCH-L1) beyond this time window.

Where it's running

• UCLA-Olive View Medical Center
  Sylmar, California, United States Recruiting
• Harbor-UCLA Medical Center
  Torrance, California, United States Recruiting
• Henry Ford Macomb (HFM)
  Clinton Township, Michigan, United States Recruiting
• Henry Ford Hospital (HFH)
  Detroit, Michigan, United States Recruiting
• Hillsboro Medical Center
  Portland, Oregon, United States Recruiting
• Oregon Health & Science University (OHSU)
  Portland, Oregon, United States Recruiting

Study contacts

• Principal investigator: Frederick Korley, MD, PhD — University of Michigan
• Study coordinator: Devon Newman, MS
• Email: devonn@med.umich.edu
• Phone: 734-652-9679

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.