In-Field Detection of Acute Intracranial Hemorrhage Requiring Urgent, Life-Saving Treatment in Severe Traumatic Brain Injury (TBI) Patients

Duke University1 site in 1 country53 target enrollmentFebruary 3, 2021

ConditionsTraumatic Brain Injury

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Traumatic Brain Injury
Sponsor: Duke University
Enrollment: 53
Locations: 1
Primary Endpoint: Optic nerve sheath diameter
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a research study to develop a noninvasive test using ultrasound to determine when urgent, life-saving treatment is needed for those with severe traumatic brain injuries.

Registry

clinicaltrials.gov

Start Date

February 3, 2021

End Date

February 10, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Duke University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adults 18 or older
•Able to provide legally effective consent
•Healthy Volunteer

Exclusion Criteria

•Intracranial disease, neurologic symptoms, or eye pathology
•Patient Inclusion Criteria:
•Adults age 18 or older
•Confirmed or suspected severe traumatic brain injury
•Able to provide legally effective consent
•Patient Exclusion Criteria:
•Significant bilateral ocular trauma

Outcomes

Primary Outcomes

Optic nerve sheath diameter

Time Frame: Approximately 10 minutes at the time of ultrasounds

Develop software that will automatically measure optic nerve sheath diameter by analyzing the radio frequency data from an ultrasound probe intervention from those that do not, we will measure the optic nerve sheath diameter manually in the cross-sectional images.