Traumatic Brain Injury Clinical Trials

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Effectiveness of the Traumatic Brain Injury Whole Blood Test on Improving Assessment and Triage for Patients With GCS 13-15 Presenting to Emergency Departments

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
United States
Pennsylvania
University of Pittsburgh
RECRUITING
Pittsburgh
Contact Information
Primary
Shawn Eagle, PhD
eaglesr2@upmc.edu
412-624-2041
Backup
Kathryn Edelman, MS
dunfeekl@upmc.edu
412-624-1077
Time Frame
Start Date: 2026-01-13
Estimated Completion Date: 2030-04
Participants
Target number of participants: 340
Treatments
ED Providers
Treating providers in the emergency department
ED patients
Patients in the emergency department with GCS 13-15 with suspected TBI
Related Therapeutic Areas
Sponsors
Collaborators: United States Department of Defense
Leads: Shawn Eagle

This content was sourced from clinicaltrials.gov