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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 Oct 18, 2026, 3:54 AM 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 31, 2020 (Actual)
Primary completion
Jun 26, 2023 (Actual)
Completion
Nov 29, 2023 (Actual)
Last update posted
Sep 19, 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 19, 2024 · Synced Oct 18, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04171960 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →