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

NCT ID: NCT07094230

Last Updated: 2025-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2026-08-31

Brief Summary

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

Detailed Description

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

Conditions

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Blood

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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blood biomarkers analyses

blood biomarkers analyses

Group Type EXPERIMENTAL

biomarkers analyses

Intervention Type DIAGNOSTIC_TEST

blood analyses

Interventions

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biomarkers analyses

blood analyses

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

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Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Captain James A. Lovell Federal Health Care Center

FED

Sponsor Role lead

Responsible Party

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Jim Buskirk PT, DPT, PhD, MS Ed

Co-Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James Buskirk, PT, DPT, PhD, MS

Role: STUDY_DIRECTOR

Captain James A. Lovell Federal Health Care Center

Locations

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Captain James A. Lovell Federal Health Care Center

North Chicago, Illinois, United States

Site Status

Countries

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United States

Central Contacts

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Bharathi Swaminathan, MD

Role: CONTACT

224-610-4152

Facility Contacts

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Bharathi Swaminathan, MD

Role: primary

+1 224-610-4157

James K Buskirk, PT, DPT, PhD, MS Ed

Role: backup

+1 630-926-7045

Related Links

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Other Identifiers

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1850604

Identifier Type: -

Identifier Source: org_study_id

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