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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
No Placebo-Only Group

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

Timeline

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

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
1,083 Previous Clinical Trials
1,058,159 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
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