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Device

Transcranial Doppler Monitoring for Brain Injury

N/A

Recruiting

Led By Darryl Miles

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ages 28 days-18 years admitted to the PICU at Children's Medical Center Dallas

Spontaneous intracranial hemorrhage

Must not have

Receiving an inhalational anesthetic agent

Hemoglobinopathy, myoglobinemia or and hyperbilirubinemia (due to inaccurate NIRS readings)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months post discharge.

Awards & highlights

Summary

This trial will look at two methods for measuring how well the brain regulates blood flow and oxygen levels, which is important for understanding brain injury.

Who is the study for?

This trial is for children and teens (28 days to 18 years old) who have had a serious brain injury like trauma or stroke within the last day. They must be in the PICU at Children's Medical Center Dallas with an arterial line already placed for care, and some may also have ICP monitoring.

What is being tested?

The study is testing two new ways to measure how well blood flow in the brain responds after injury using non-invasive monitors. It looks at changes in blood pressure and blood flow velocity or oxygenation in the brain to assess cerebral autoregulation.

What are the potential side effects?

Since this trial uses non-invasive monitoring techniques such as Transcranial Doppler, side effects are minimal but could include discomfort from wearing headgear needed for assessment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 28 days and 18 years old and admitted to the PICU at Children's Medical Center Dallas.

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I have had a bleeding in my brain without injury.

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I experienced a sudden neurological injury less than 24 hours ago.

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I have an ICP monitor installed as part of my standard care.

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I have or will soon have an arterial line placed for my care.

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I have had a severe brain injury or condition like a stroke or severe epilepsy.

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I have had a prolonged or repeated seizure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently receiving treatment with inhaled anesthesia.

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I do not have blood disorders affecting hemoglobin, myoglobin, or high bilirubin levels.

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I cannot have certain brain scans due to severe facial or head injuries.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months post discharge.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months post discharge.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post discharge. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Glasgow Outcome Scale Extended-Pediatrics (GOSEP) score

Change in Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT) score

Transfer Function Analysis

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Study SubjectsExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcranial Doppler

2018

Completed Phase 1

~810

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

Southern Methodist UniversityOTHER

36 Previous Clinical Trials

5,966 Total Patients Enrolled

The University of Texas at ArlingtonOTHER

44 Previous Clinical Trials

4,835 Total Patients Enrolled

University of Texas Southwestern Medical CenterLead Sponsor

1,072 Previous Clinical Trials

1,056,232 Total Patients Enrolled

Media Library

Transcranial Doppler (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04242602 — N/A

Traumatic Brain Injury Research Study Groups: Study Subjects

Traumatic Brain Injury Clinical Trial 2023: Transcranial Doppler Highlights & Side Effects. Trial Name: NCT04242602 — N/A

Transcranial Doppler (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04242602 — N/A

~1 spots leftby Jan 2025

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