Recruiting

i-STAT Alinity

Sponsor:

Shawn Eagle

Code:

NCT07373509

Conditions

TBI (Traumatic Brain Injury)

Implementation Research

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

i-STAT Alinity TBI test

Study Details

Brief summary:

The objective of this study is to identify determinants for implementing the i-STAT Alinity whole blood traumatic brain injury (TBI) test for its Food and Drug Administration (FDA)-indicated use and to evaluate other potential outcomes with clinical implications. The main questions it aims to answer are:

1. Determine the number of patients with non-elevated (i.e., below clinical cutoff) whole blood iSTAT Alinity tests who also receive CT scans.
2. What are the obstacles for using the i-STAT Alinity for its FDA-indicated use

Conditions

TBI (Traumatic Brain Injury)

Implementation Research

Study ID

NCT07373509

Start date

Jan 13, 2026

Status verified date

Feb, 2026

Completion date

Apr, 2030

Anticipated

Primary completion date

Mar, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Aged 18 or older
2. Presenting to an enrolling ED with ED Arrival GCS of 13-15 following reported head blunt impact within 24 hours of injury
3. Meets Department of Defense (DoD) definition of mTBI:

A traumatically induced physiological disruption of brain function as a result of an external force that is indicated by new onset or worsening of at least one of the following clinical signs immediately following the event:

1. Any alteration of mental status (e.g., feeling dazed, disoriented, or confused)
2. Any period of loss of or a decreased level of consciousness, observed or self-report (loss of consciousness 30 minutes or less, an alteration of consciousness up to 24 hours)
3. Any loss of memory for events immediately before or after the injury (post-traumatic amnesia up to 1-day post-injury)

Exclusion Criteria:

1. Treating emergency department provider does not think a head CT scan is needed
2. Inability to obtain results for iSTAT Alinity TBI test within 24 hours of injury
3. Treating emergency department attending physician is not willing to participate
4. Pre-existing neurologic condition
5. Contraindication or inability to complete blood draw
6. Significant polytrauma that, in the opinion of the principal investigators, could impact peripheral GFAP levels or require a full body scan
7. History of penetrating TBI
8. History of neurosurgical intervention for previous TBI
9. Penetrating TBI for current injury
10. Any history of brain surgery
11. Any history of brain tumor
12. Patients on psychiatric hold

Study Design

Enrollment

340 participants

Anticipated

Interventions and Outcome Measures

Arms

ED Providers

Treating providers in the emergency department

ED patients

Patients in the emergency department with GCS 13-15 with suspected TBI

Interventions

i-STAT Alinity TBI test

The i-STAT TBI cartridge is a point-of-care test that measures the level of biomarkers associated with brain injury in whole blood to help assess patients with suspected mTBI within 24 hours after injury.

Primary outcome measure

  • Rate of CT scans completed [ Time Frame: Up to 5 hours (from enrollment to CT scan completion) ]

Central Contacts and Locations

Central contacts

Locations

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

More Information

Sponsor

Shawn Eagle

Last update posted

Jul 6, 2026

Last verified

Feb, 2026

Keywords

  • Concussion
  • Traumatic Brain Injury
  • CT scan
  • Blood Biomarker
  • i-STAT Alinity TBI Test

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Shawn Eagle on 2026-07-06.