Emergency Department Implementation of the i-STAT Alinity Traumatic Brain Injury Whole Blood Test
Recruiting
Observational Study
TBI (Traumatic Brain Injury)
Implementation Research
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 340 (estimated)
- Sponsor
- Shawn Eagle · Other
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About This Trial
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 blo…
Trial Locations
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Eligibility Criteria
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 resu…
Contacts