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

Effectiveness of the Traumatic Brain Injury Whole Blood Test on Improving Assessment and Triage for Patients With GCS 13-15 Presenting to Emergency Departments

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

Study Overview

• Status: Recruiting
• Conditions: TBI (Traumatic Brain Injury); Implementation Research
• Intervention / Treatment: Device: i-STAT Alinity TBI test

Detailed Description

Objective:

The objective of this study is to utilize the integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework to identify determinants for implementing the 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.

Specific Aims & working hypotheses:

Aim 1) Evaluate the effectiveness of the whole blood iSTAT Alinity test in determining the need for a head computed tomography (CT) scan in approximately 140 patients with a Glasgow Coma Score (GCS) 13-15 in the emergency department (ED) (approximately 47 per site) while assessing two novel outcomes with significant clinical implications (i.e., reduction in ED length of stay and predictive utility for ED revisits for the same injury).

• The working hypotheses are that the rate of patients with non-elevated (i.e., below clinical cutoff) whole blood iSTAT Alinity tests who also receive CT scans will mirror the preliminary study results (21 percent), a reduction in ED length of stay will be observed (in comparison to also receiving a CT scan) of greater than 3 hours, and predictive utility for return ED visits from the same injury will be high (area under the curve greater than 0.80).

Aim 2) Evaluate determinants for routine use of the whole blood iSTAT Alinity test by assessing acceptability, adoption, appropriateness and feasibility of the test at the organizational- and physician-level for each site and determine how these factors interplay with patient perspectives and knowledge to influence implementation of the test.

• The working hypotheses are that organization-, physician-, and patient-level determinants will be identified and gaps in patient knowledge will be observed. A diverse Community Advisory Board (CAB) will be assembled to provide important context of how these varying perspectives impact the whole blood iSTAT Alinity test utilization. We will also obtain community knowledge and perspective on this test via the CAB.

Aim 3) Develop a site-specific implementation blueprint for use of the whole blood iSTAT Alinity test in determining the need for a head CT scan and pilot test the blueprint in approximately 140 patients with GCS 13-15 in the ED (approximately 47 per site).

• The working hypothesis is that an implementation blueprint that targets identified determinants in Aim 2 will lead to a reduction in the rate of patients with negative whole blood iSTAT tests who also receive CT scan to 5 percent or less.

• Study Type: Observational
• Enrollment (Estimated): 340

Contacts and Locations

• Study Contact: Name: Kathryn Edelman, MS; Phone Number: 412-624-1077; Email: dunfeekl@upmc.edu
• Study Contact Backup: Name: Shawn Eagle, PhD; Phone Number: 412-624-2041; Email: eaglesr2@upmc.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • University of Pittsburgh
      • Contact: Kathryn Edelman, MS; Phone Number: 412-624-1077; Email: dunfeekl@upmc.edu
      • Contact: Shawn Eagle, PhD; Phone Number: 412-624-1077; Email: eaglesr2@upmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Emergency department providers and patients with suspected TBI

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
ED patient length of stay		Up to 5 hours (from arrival to discharge)
Patient return visit to ED	Return visit for same injury within 2 weeks of initial visit	Up to two weeks
Military Acute Concussion Evaluation-2 (MACE-2)	MACE 2 is a 15-minute multimodal tool that assists providers in the assessment and diagnosis of concussion. It includes: An unscored screening section collected by clinician interview; A cognitive exam with scores ranging 0-30; with higher scores representing better performance. A score of 25 or less is considered abnormal.; Normal/Abnormal ratings of neurological function, symptom report, and visual-ocular functioning A total score is not generated.	Visit 1 (ED visit)
Neurobehavioral Symptom Inventory (NSI)	The NSI is a 22-item scale of TBI symptoms which takes 2 minutes to complete. Total scores range from 0-88, with higher scores indicating more severe symptom burden.	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)	This is a 13-item survey to evaluate existing knowledge of concussion, which takes 2 minutes to complete. All questions are true/false. Correct responses get one point, with total scores ranging 0-13; higher scores indicate greater knowledge.	Visit 1 (ED visit)
Mobilizing Implementation of iPARIHS Facilitation Planning Tool (Mi-PARIHS)	This is a 34-item survey to be filled out by ED providers to identify determinants for implementation of the I-STAT TBI test. Each item is rated with a 5-item likert-scale, rated -2 to +2, to identify barriers and facilitators/enablers for the i-STAT TBI test. Lower scores indicate more barriers.	Visit 1 (enrollment) and again at 39 months (study conclusion)
Decisional Conflict Scale (DCS)	The DCS is a 16-item survey about decision-making to be filled out by ED providers. It measures 5 dimensions of decision making, with factors related to feeling uncertain, uninformed, unclear about values, unsupported, or ineffective decision making. All items are scored on a Likert scale ranging from 1 (strongly agree) to 5 (strongly disagree). Total scores range from 16-80; a higher score indicates a higher level of decisional conflict.	Visit 1 (enrollment) and again at 39 months (study conclusion)
Implementation Questionnaire	This is a 4-item survey about the i-STAT TBI test implementation to be filled out by ED providers. All items are scored on a Likert scale ranging from 1 (completely disagree) to 5 (completely agree). Total scores range from 4-20; a higher score indicates a higher level of i-STAT TBI test implementation acceptance.	Visit 1 (enrollment) and again at 39 months (study conclusion)

Collaborators and Investigators

• Sponsor: Shawn Eagle
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Shawn Eagle, PhD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): April 1, 2030

Study Registration Dates

• First Submitted: December 5, 2025
• First Submitted That Met QC Criteria: January 22, 2026
• First Posted (Actual): January 28, 2026

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Concussion; Traumatic Brain Injury; CT scan; Blood Biomarker; i-STAT Alinity TBI Test
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
• Other Study ID Numbers: STUDY25010137; HT94252510275 (Other Grant/Funding Number: Department of Defense; Dept. of the Army -- USAMRAA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be made available through the Federal Interagency TBI Research
• IPD Sharing 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.
• IPD Sharing Access Criteria: FITBIR qualified investigators will be provided access

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No