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Completed No phase listed Observational

Clinical Evaluation of the i-STAT TBI Test

ClinicalTrials.gov ID: NCT04171960

Public ClinicalTrials.gov record NCT04171960. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 5:31 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The goal of this study is to evaluate the i-STAT TBI test to assist determining the need for a computed tomography (CT) scan in patients with suspected mild traumatic brain injury (TBI). Patients will be asked to provide a blood sample.

Study identification

NCT ID
NCT04171960
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
Abbott Point of Care
Industry
Enrollment
1,106 participants

Conditions and interventions

Interventions

Diagnostic Test · Other

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 30, 2020
Primary completion
Jun 25, 2023
Completion
Nov 28, 2023
Last update posted
Sep 18, 2024

2020 – 2023

United States locations

U.S. sites
21
U.S. states
15
U.S. cities
20
Facility City State ZIP Site status
University of California, San Francisco San Francisco California 94143
Denver Health and Hospital Authority Denver Colorado 80204
Craig Hospital Englewood Colorado 80113
University of Miami Miami Florida 33136
Rehabilitation Hospital of Indiana Carmel Indiana 46032
Indiana University School of Medicine Indianapolis Indiana 46202
University of Kentucky Lexington Kentucky 40536
University of Maryland Medical Center Baltimore Maryland 21201
Massachusetts General Hospital Boston Massachusetts 02114
University of Rochester Medical Center Rochester New York 14642
University of Cincinnati Cincinnati Ohio 45219
Penn Presbyterian Medical Center Philadelphia Pennsylvania 19104
University of Pittsburgh Medical Center Presbyterian Hospital Pittsburgh Pennsylvania 15213
University of Texas, Austin Austin Texas 78701
University of Texas, South Western Dallas Texas 75390
Baylor College of Medicine Houston Texas 77030
University of Texas Health Sciences Center of Houston Houston Texas 77030
University of Utah Salt Lake City Utah 84132
Virginia Commonwealth University Richmond Virginia 23298
University of Washington Seattle Washington 98104
Medical College of Wisconsin Milwaukee Wisconsin 53226

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04171960, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 18, 2024 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04171960 live on ClinicalTrials.gov.

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