Combination iSTAT/Alinity and IR Oculography for Head CT... | NCT07094230

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

NCT07094230

Sponsor

Captain James A. Lovell Federal Health Care Center

Status

Not yet recruiting

Last Update Posted

Aug 1, 2025Actual

Enrollment

75Estimated

Phase

Not Applicable

Conditions

Blood

Interventions

biomarkers analyses

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2025Estimated

Primary Completion Date

Aug 2026Estimated

Completion Date

Aug 2026Estimated

First Submitted Date

Jul 23, 2025

First Submission Date that Met QC Criteria

Jul 23, 2025

First Posted Date

Jul 30, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 29, 2025

Last Update Posted Date

Aug 1, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jim Buskirk PT, DPT, PhD, MS Ed, Co-Investigator, Captain James A. Lovell Federal Health Care CenterPrincipal Investigator

Lead Sponsor

Captain James A. Lovell Federal Health Care CenterFED

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
blood biomarkers analyses	Experimental	blood biomarkers analyses	Diagnostic Test: biomarkers analyses

Interventions

Name	Type	Description	Arm Group Labels	Other Names
biomarkers analyses	Diagnostic Test	blood analyses	blood biomarkers analyses

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
blood biomarkers analyses	Alinity device analyses of GFAP and UCH-L1	same day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Bharathi Swaminathan, MD	Contact	224-610-4152		Bharathi.Swaminathan2@va.gov

Overall Officials

Name	Affiliation	Role
James Buskirk, PT, DPT, PhD, MS	Captain James A. Lovell Federal Health Care Center	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Captain James A. Lovell Federal Health Care Center		North Chicago	Illinois	60064	United States

Label	URL
Blood biomarkers analyses	View source

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

blood analyses results, IR Oculography results, recovery timelines questionnaires data

Types

Statistical Analysis Plan (SAP)

Time Frame

August 1, 2025 -- August 1, 2026

Access Criteria

Rosalind Franklin University Dept of Statistics, IPD, via electronic data transfer

URL

https://department.va.gov/administrations-and-offices/enterprise-integration/data-governance-and-analytics/