Emergency Department Implementation of the i-STAT Alinity Traumatic Brain Injury Whole Blood Test
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShawn Eagle
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 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
Eligibility criteria
Qualifiers
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
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- i-STAT Alinity TBI test
Treatment groups
340 Participants
are divided into 2 treatment groupsSponsors and collaborators
Shawn Eagle
Lead sponsor
University of Pittsburgh
Sponsor institution
United States Department of Defense
Collaborator
Source ClinicalTrials.gov