718 - Combination iSTAT/Alinity & Video Infrared Oculography for Head Computed Tomography (CT) Necessity and Recovery Prediction after mild Traumatic Brain Injury (mTBI)

Mild traumatic brain injury (mTBI) is common yet underdiagnosed in emergency care, where computed tomography (CT) lacks sensitivity for functional deficits. This pilot evaluates a dual-modality pathway, point-of-care brain biomarkers (GFAP, UCH-L1 via i-STAT Alinity; FDA-cleared) plus infrared oculography (DeCon), to identify patients who may not require head CT and to predict symptom recovery. The goal is to enhance triage precision, reduce unnecessary imaging, and guide timely referrals; findings will inform feasibility and design for future multisite trials.

Design:

Prospective pilot at FHCC-Lovell Department of Veterans Affairs (VA) enrolling 50-80 adults with clinician-confirmed mTBI (Glasgow Coma Scale 13-15, ≤12 hours post-injury). Baseline biomarkers and oculography are repeated at 2 and 4 hours and at emergency department (ED) discharge (≤3 repeats). CT is obtained per clinician judgment; study results are blinded to treating teams. Rivermead follow-ups occur at days 7, 14, 30, and 60. Institutional Review Board (IRB) and Research and Development (R&D) approvals are complete; devices calibrated and workflows validated; data captured under Standard Operating Procedures (SOPs) in secure VA systems.

Results:

Enrollment began August 2025. Initial participants completed the full protocol. IR oculography detected impairments in saccades, vergence, and reaction time that correlated with symptom burden. Several CT-negative cases showed elevated biomarkers alongside oculography deficits, supporting added value beyond CT. Interim analyses will estimate diagnostic accuracy (sensitivity, specificity, NPV, AUC), feasibility (repeat-test completion, time-to-result, follow-up adherence), and model potential CT reduction via decision-curve analysis.




Conclusions:

A feasible, scalable multimodal ED pathway integrating point-of-care biomarkers with IR oculography shows early diagnostic and prognostic signal beyond CT, supporting imaging stewardship and earlier, targeted referrals. These pilot data justify a multisite trial to validate thresholds, quantify CT reduction and workflow impact, and evaluate longer-term outcomes across VA and civilian systems.