BloodNCT07094230
Combination iSTAT/Alinity and IR Oculography for Head CT Necessity and Recovery Prediction After mTBI
A study testing biomarkers analyses in people with Blood, run by Captain James A. Lovell Federal Health Care Center at 1 site in United States.
Trial summary
Use of blood biomarkers and eye tracking after traumatic brain injury for recovery timeline prediction Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Blood
- What is being tested?
- biomarkers analyses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2025to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-85, Communicative in English language, With clinician-confirmed mTBI (GCS 13-15, ≤24 hours post-injury)
Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Captain James A. Lovell Federal Health Care Center
North Chicago, Illinois, 60064
Bharathi Swaminathan, MD, +1 224-610-4157, BharathiSwaminathan2@va.gov
James K Buskirk, PT, DPT, PhD, MS Ed, +1 630-926-7045, james.buskirk@va.gov
About this study
Use of blood biomarkers and eye tracking after traumatic brain injury for recovery timeline prediction
Read the detailed description
Use of blood biomarkers and video IR oculography after mTBI for necessity of head CT scan and recovery timeline prediction
- Conditions
- Blood
- Being tested
- biomarkers analyses
- Keywords
- mTBI, biomarkers, IR Oculography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biomarkers analysesDiagnostic test
blood analyses
| Study group | Role | What they receive |
|---|---|---|
| blood biomarkers analyses | Experimental | blood biomarkers analyses Receives: Diagnostic Test: biomarkers analyses |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood biomarkers analyses
Alinity device analyses of GFAP and UCH-L1
Measured: same day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BloodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Captain James A. Lovell Federal Health Care Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Jim Buskirk PT, DPT, PhD, MS Ed, Captain James A. Lovell Federal Health Care Center
- Investigators
- James Buskirk, PT, DPT, PhD, MS, Study director, Captain James A. Lovell Federal Health Care Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07094230
- Sponsor's protocol ID
- 1850604
- Status last verified
- Jul 2025
- First submitted
- 23 Jul 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: blood analyses results, IR Oculography results, recovery timelines questionnaires data
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination iSTAT/Alinity and IR Oculography for Head CT Necessity and Recovery Prediction After mTBI
- ClinicalTrials.gov ID
- NCT07094230
- Acronym / sponsor ID
- 1850604
- Conditions
- Blood
- Keywords
- mTBI, biomarkers, IR Oculography
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Captain James A. Lovell Federal Health Care CenterUS federal agency
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| blood biomarkers analyses | Experimental | Diagnostic Test: biomarkers analysesblood biomarkers analyses |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18-85, Communicative in English language, With clinician-confirmed mTBI (GCS 13-15, ≤24 hours post-injury)
Key exclusion criteria (2 listed)
- 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.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biomarkers analysesblood analyses | Diagnostic test | blood biomarkers analyses |
Primary outcome
blood biomarkers analyses
Time frame: same day
Alinity device analyses of GFAP and UCH-L1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Blood biomarkers analysesLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. blood analyses results, IR Oculography results, recovery timelines questionnaires data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James Buskirk, PT, DPT, PhD, MS study director
Captain James A. Lovell Federal Health Care Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biomarkers analyses in people with Blood, run by Captain James A. Lovell Federal Health Care Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bharathi Swaminathan, MD (224-610-4152, Bharathi.Swaminathan2@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood biomarkers analyses (time frame: same day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.