NCT07373509 · Shawn Eagle
Emergency Department Implementation of the i-STAT Alinity Traumatic Brain Injury Whole Blood Test
(EDI)
What this study is about
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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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)
Exclusion criteria
- 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
Where
- Pittsburgh, Pennsylvania
Collaborators
United States Department of Defense
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 6, 2026 · Source of record for eligibility and locations