Emergency Department Implementation of the i-STAT Alinity Traumatic Brain Injury Whole Blood Test

NCT07373509 | Recruiting FDA Device

• 2 other identifiers: STUDY25010137HT94252510275
• Study Type: observational
• Target: 340
• Locations: 1 country
• Sites: 1

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. 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. 2.What are the obstacles for using the i-STAT Alinity for its FDA-indicated use

Conditions

TBI (Traumatic Brain Injury); Implementation Research

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Rate of CT scans completed

  Rate of CTs completed for ED patient participants with a non-elevated i-STAT Alinity whole blood TBI test result.

  Up to 5 hours (from enrollment to CT scan completion)

Secondary Outcomes (8)

• ED patient length of stay

  Up to 5 hours (from arrival to discharge)

• Patient return visit to ED

  Up to two weeks

• Military Acute Concussion Evaluation-2 (MACE-2)

  Visit 1 (ED visit)

• Neurobehavioral Symptom Inventory (NSI)

  The NSI will be completed once during the patient's visit 1 (ED visit), and once at visit 2 (2-week remote follow-up)

• Modified Rosenbaum Concussion Knowledge and Attitudes Survey (RoCKAS)

  Visit 1 (ED visit)

Study Arms (2)

ED Providers

Treating providers in the emergency department

ED patients

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

Device: i-STAT Alinity TBI test

Interventions

i-STAT Alinity TBI test DEVICE

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.

ED patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Emergency department providers and patients with suspected TBI

You may qualify if:

• Aged 18 or older
• Presenting to an enrolling ED with ED Arrival GCS of 13-15 following reported head blunt impact within 24 hours of injury
• 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:
• Any alteration of mental status (e.g., feeling dazed, disoriented, or confused)
• 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)
• Any loss of memory for events immediately before or after the injury (post-traumatic amnesia up to 1-day post-injury)

You may not qualify if:

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

Sponsors & Collaborators

• Shawn Eagle: lead
• United States Department of Defense: collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum and plasma blood samples

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Head Injuries, Closed; Wounds, Nonpenetrating

Study Officials

• Shawn Eagle, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shawn Eagle, PhD

CONTACT

412-624-2041; eaglesr2@upmc.edu

Kathryn Edelman, MS

CONTACT

412-624-1077; dunfeekl@upmc.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: January 28, 2026
• Study Start: January 13, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): April 1, 2030
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: Shared scientific data will be made accessible as soon as possible, and no later than the time of an associated publication, or the end of performance period, whichever comes first.
• Access Criteria: FITBIR qualified investigators will be provided access

Locations

US (1)