An observational study in TBI (Traumatic Brain Injury) and Implementation Research, sponsored by Shawn Eagle. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by Shawn Eagle · Observational
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:
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).
1,721 studies on the registry are indexed under Brain Injuries, Traumatic; 447 are open to participants now.
This study's planned enrollment of 340 is above the median of 117 across 557 observational studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →This is the only study on the registry with Shawn Eagle as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Emergency department providers and patients with suspected TBI
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treating providers in the emergency department
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.
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.
Time frame: Up to 5 hours (from enrollment to CT scan completion)
ED patient length of stay
Time frame: Up to 5 hours (from arrival to discharge)
Patient return visit to ED
Return visit for same injury within 2 weeks of initial visit
Time frame: 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: 1. An unscored screening section collected by clinician interview 2. A cognitive exam with scores ranging 0-30; with higher scores representing better performance. A score of 25 or less is considered abnormal. 3. Normal/Abnormal ratings of neurological function, symptom report, and visual-ocular functioning A total score is not generated.
Time frame: 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.
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)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Visit 1 (enrollment) and again at 39 months (study conclusion)
Plan to share: Yes — Data will be made available through the Federal Interagency TBI Research
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
Data sharing details ↗ · fitbir.nih.gov
No publications or documents are linked to this record.
Started Jan 2026 (actual). Primary completion is estimated for Mar 2029, 38 months after the start.
Of 228 non-industry observational studies under Brain Injuries, Traumatic, half reached primary completion within 50 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 95. This study's planned 38 months is below that.
Counting every sponsor, half of 250 studies reached it within 49 months; a quarter within 23 and three quarters within 95.
How these figures are worked out, and which studies are left out of them.
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