Emergency Department Implementation of the i-STAT Alinity Traumatic Brain Injury Whole Blood Test

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Shawn Eagle
Study ID
NCT07373509
Status
Recruiting
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Conditions

  • Implementation Research
  • TBI (Traumatic Brain Injury)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • i-STAT Alinity TBI test — DEVICE
    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.

Study Details

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

Key Dates

Start date
Jan 13, 2026
Status verified
Feb 2026
Primary completion
Mar 31, 2029
Completion
Apr 30, 2030

Study Design

Enrollment
340 participants (estimated)

Arms

  • Arm: ED Providers
    Treating providers in the emergency department
  • Arm: ED patients
    Patients in the emergency department with GCS 13-15 with suspected TBI

Primary Outcome Measure

Rate of CT scans completed [ Time Frame: Up to 5 hours (from enrollment to CT scan completion) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of PittsburghPittsburghPennsylvania15213
Shawn Eagle, PhD
[email protected]
412-624-1077
Kathryn Edelman, MS
[email protected]
412-624-1077

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By research site
University of Pittsburgh· Pittsburgh, PA

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