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NCT04242602 · ClinicalTrials.gov registry record · NA
Multimodal Monitoring of Cerebral Autoregulation After Pediatric Brain Injury
A NA study of Traumatic Brain Injury and Brain Injuries, sponsored by University of Texas Southwestern Medical Center.
- Recruiting
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT04242602: Recruiting NA study of Traumatic Brain Injury and Brain Injuries, sponsored by University of Texas Southwestern Medical Center.
NCT04242602 is a NA study of Traumatic Brain Injury and Brain Injuries that is actively recruiting participants, run by University of Texas Southwestern Medical Center. The registered enrollment target is 30 participants, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04242602, a NA study of Traumatic Brain Injury and Brain Injuries, is actively recruiting participants, sponsored by University of Texas Southwestern Medical Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
Various methods have been studied to evaluate autoregulation. However, there is currently no universally accepted technique to assess integrity of the cerebral autoregulation neurovascular system. In the last decade, significant progress has been achieved in developing methods to assess cerebral autoregulation by quantifying cross-correlation between spontaneous oscillations in CBF or oxygenation and similar oscillations in arterial blood pressure. In this study the investigators will analyze the relationship between spontaneous fluctuations in mean arterial blood pressure and cerebral blood flow velocity or cerebral regional oxygenation to investigate two novel methods for measuring cerebral autoregulation, Transfer Function Analysis and Wavelet Coherence after acute pediatric brain injury.
Primary Outcome
The transfer function has three components: I. Gain: This measures the magnitude of transmission of MAP oscillations to CBFv. Effectively, a functional dCA system dampens the strength of transmitted oscillations resulting in a lower gain value. A higher gain value is therefore suggestive of impaired autoregulation. II. Phase is a "time delay" in degrees measured between the two waveforms. Absence of autoregulation would result in both MAP and CBFV changing at the same time. This would be measu
Conditions Studied
Interventions
- DEVICE Transcranial Doppler
Study Locations (1)
Texas
- Children's Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2018-11-06 |
| Est. Completion | 2030-01 |
| Phase | NA |
What NCT04242602 shows while recruiting
NCT04242602 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (89% lower).
The record links to 3 conditions, with Traumatic Brain Injury appearing as the primary indexed condition, and to 1 intervention - of which Transcranial Doppler is the first listed.
NCT04242602 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04242602 about?
NCT04242602 is a clinical study titled "Multimodal Monitoring of Cerebral Autoregulation After Pediatric Brain Injury". Various methods have been studied to evaluate autoregulation. However, there is currently no universally accepted technique to assess integrity of the cerebral autoregulation neurovascular system. In the last decade, significant progress has been achieved in developing methods to assess cerebral aut...
What is the current status of trial NCT04242602?
This trial is currently recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2018-11-06. Estimated completion is 2030-01.
What conditions does trial NCT04242602 study?
This clinical trial studies the following conditions: Traumatic Brain Injury, Brain Injuries, Brain Injury, Vascular.
What interventions are being tested in trial NCT04242602?
The interventions under investigation include: Transcranial Doppler (DEVICE).
Who is sponsoring clinical trial NCT04242602?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04242602 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04242602's enrollment target sits among peer trials
30 139th of 171 higher than 29 of 171 other Traumatic Brain Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Traumatic Brain Injury trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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