TBI (Traumatic Brain Injury)EDINCT07373509
Emergency Department Implementation of the i-STAT Alinity Traumatic Brain Injury Whole Blood Test
An observational study of TBI (Traumatic Brain Injury) and Implementation Research, run by Shawn Eagle at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- TBI (Traumatic Brain Injury), Implementation Research
- What is being tested?
- i-STAT Alinity TBI test
- Type of treatment
- Medical device
- How many people
- 340 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2026to Apr 2030
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Emergency department providers and patients with suspected TBI
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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
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, 1 recruiting
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Shawn Eagle, PhD, 412-624-1077, eaglesr2@upmc.edu
Kathryn Edelman, MS, 412-624-1077, dunfeekl@upmc.edu
About this study
Official title: 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:
- Determine the number of patients with non-elevated (i.e., below clinical cutoff) whole blood iSTAT Alinity tests who also receive CT scans.
- What are the obstacles for using the i-STAT Alinity for its FDA-indicated use
Read the 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:
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).
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.
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).
- Being tested
- i-STAT Alinity TBI test
- Keywords
- Concussion, Traumatic Brain Injury, CT scan, Blood Biomarker, i-STAT Alinity TBI Test
- Medical subject headings
- Brain Injuries, Traumatic, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
i-STAT Alinity TBI testDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| ED Providers | Treating providers in the emergency department | |
| ED patients | Patients in the emergency department with GCS 13-15 with suspected TBI Receives: Device: i-STAT Alinity TBI test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 5 hours (from enrollment to CT scan completion)
Secondary outcomes (8)
ED patient length of stay
Measured: Up to 5 hours (from arrival to discharge)
Patient return visit to ED
Return visit for same injury within 2 weeks of initial visit
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Visit 1 (enrollment) and again at 39 months (study conclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start13 Jan 2026
- Primary completionMar 2029 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TBI (Traumatic Brain Injury)Studies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shawn Eagle
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor-investigator, Shawn Eagle, University of Pittsburgh
- Investigators
- Shawn Eagle, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07373509
- Sponsor's protocol ID
- STUDY25010137
- Other IDs
- HT94252510275
- Acronym
- EDI
- Status last verified
- Feb 2026
- First submitted
- 5 Dec 2025
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data will be made available through the Federal Interagency TBI Research
Publications
Eagle S, McNett M, Madhok D, Bazarian J, Barton D, Edelman K, Sharpless J, Sugar G, Gotthardt C, Wu A, Zhang V, Tran N, Degener S, Merchant-Borna K, Manley G, Okonkwo D. Implementing whole blood TBI point-of-care testing in Level 1 trauma centers: protocol for emergency department implementation for TBI (EDI for TBI) hybrid type II effectiveness-implementation trial. Front Health Serv. 2026 Jul 28;6:1891721. doi: 10.3389/frhs.2026.1891721. eCollection 2026.
PubMed 42582391
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Traumatic Brain Injury Whole Blood Test on Improving Assessment and Triage for Patients With GCS 13-15 Presenting to Emergency Departments
- ClinicalTrials.gov ID
- NCT07373509
- Acronym / sponsor ID
- EDI / STUDY25010137
- Keywords
- Concussion, Traumatic Brain Injury, CT scan, Blood Biomarker, i-STAT Alinity TBI Test
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Shawn EagleUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 13 Jan 2026 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 28 Jan 2026 (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.
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:
- Determine the number of patients with non-elevated (i.e., below clinical cutoff) whole blood iSTAT Alinity tests who also receive CT scans.
- What are the obstacles for using the i-STAT Alinity for its FDA-indicated use
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:
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).
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.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ED Providers | – | –Treating providers in the emergency department |
| ED patients | – | Device: i-STAT Alinity TBI testPatients in the emergency department with GCS 13-15 with suspected TBI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Emergency department providers and patients with suspected TBI
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
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 |
|---|---|---|
| i-STAT Alinity TBI testThe 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. | Device | ED patients |
Primary outcome
Rate of CT scans completed
Time frame: Up to 5 hours (from enrollment to CT scan completion)
Rate of CTs completed for ED patient participants with a non-elevated i-STAT Alinity whole blood TBI test result.
8 secondary outcomes
ED patient length of stay
Time frame: Up to 5 hours (from arrival to discharge)
Patient return visit to ED
Time frame: Up to two weeks
Military Acute Concussion Evaluation-2 (MACE-2)
Time frame: Visit 1 (ED visit)
Neurobehavioral Symptom Inventory (NSI)
Time frame: 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)
Time frame: Visit 1 (ED visit)
Mobilizing Implementation of iPARIHS Facilitation Planning Tool (Mi-PARIHS)
Time frame: Visit 1 (enrollment) and again at 39 months (study conclusion)
Decisional Conflict Scale (DCS)
Time frame: Visit 1 (enrollment) and again at 39 months (study conclusion)
Implementation Questionnaire
Time frame: Visit 1 (enrollment) and again at 39 months (study conclusion)
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 6 Jul 2026.
- Derived from this study: PubMed 42582391Eagle S, McNett M, Madhok D, Bazarian J, Barton D, Edelman K, Sharpless J, Sugar G, Gotthardt C, Wu A, Zhang V, Tran N, Degener S, Merchant-Borna K, Manley G, Okonkwo D. Implementing whole blood TBI point-of-care testing in Level 1 trauma centers: protocol for emergency department implementation for TBI (EDI for TBI) hybrid type II effectiveness-implementation trial. Front Health Serv. 2026 Jul 28;6:1891721. doi: 10.3389/frhs.2026.1891721. eCollection 2026.
- Individual participant dataSharing planned: Yes. Data will be made available through the Federal Interagency TBI Research
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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.
Shawn Eagle, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of TBI (Traumatic Brain Injury) and Implementation Research, run by Shawn Eagle 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 7 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 6 Jul 2026. 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 Shawn Eagle, PhD (412-624-2041, eaglesr2@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of CT scans completed (time frame: Up to 5 hours (from enrollment to CT scan completion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07373509, which also lists 1 linked publication.
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 6 Jul 2026.