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NCT04515212 Clinical Trial

In-Field Detection of Intracranial Pressure

Traumatic Brain Injury Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT04515212
Other study ID # Pro00104100
Secondary ID
Status Suspended
Phase N/A
First received
Last updated
Start date February 3, 2021
Est. completion date December 31, 2024

Study information
Verified date April 2024
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Suspended
Enrollment 120
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility Healthy Volunteer 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Optic Nerve Ultrasounds
Patients will have up to four ultrasounds of the optic nerve.

Locations
Country Name City State
United States Duke University Medical Center Durham North Carolina

Sponsors (2)
Lead Sponsor Collaborator
Duke University United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Optic nerve sheath diameter 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. Approximately 10 minutes at the time of ultrasounds
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