Emergency Department Implementation of the i-STAT Alinity Traumatic Brain Injury Whole Blood Test (NCT07373509) | Clinical Trial Compass
RecruitingNot Applicable
Emergency Department Implementation of the i-STAT Alinity Traumatic Brain Injury Whole Blood Test
United States340 participantsStarted 2026-01-13
Plain-language 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. 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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
✓. 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
What they're measuring
1
Rate of CT scans completed
Timeframe: Up to 5 hours (from enrollment to CT scan completion)