Combination iSTAT/Alinity and IR Oculography for Head CT Necessity and Recovery Prediction After mTBI

Not Applicable

Not yet recruiting

• Conditions: Blood

• Registration Number: NCT07094230
• Lead Sponsor: Captain James A. Lovell Federal Health Care Center

Brief Summary

Use of blood biomarkers and eye tracking after traumatic brain injury for recovery timeline prediction

Detailed Description

Use of blood biomarkers and video IR oculography after mTBI for necessity of head CT scan and recovery timeline prediction

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-23
• Study First Submitted QC: 2025-07-23
• Last Update Submitted: 2025-07-29
• Study First Posted: 2025-07-30
• Study Start: 2025-08-01
• Last Update Posted: 2025-08-01
• Primary Completion: 2026-08
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Patients aged 18-85, Communicative in English language, With clinician-confirmed mTBI (GCS 13-15, ≤24 hours post-injury)

Exclusion Criteria

Neurological, vestibular, or visual disorders, Significant comorbidities, Prior TBI (<6 months) Special populations (pregnant, incarcerated, active-duty recruits). Active-duty recruits excluded due to inability to contact them at scheduled intervals for remote follow-up questionnaires.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
blood biomarkers analyses	same day	Alinity device analyses of GFAP and UCH-L1

Trial Locations

Locations (1)

Captain James A. Lovell Federal Health Care Center; 🇺🇸 North Chicago, Illinois, United States