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NCT06511804Recruiting

Correlation Between Noninvasive Blood Vessel Functionality Parameters and Cerebral Hemodynamics in Neurocritical Care Patients

Source: ClinicalTrials.gov · Last updated 30 May 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

The purpose of this clinical research project is to employ Mespere LifeSciences NeurOs Cerebral Oximetry system, equipped with noninvasive sensors approved by the FDA, to monitor and investigate the correlation within a cohort of patients suffering from traumatic brain injury (TBI), stroke, brain tumor, and brain bleeding. This study aims to investigate and establish the correlation between blood vessel functionality parameters-specifically, Vasodilation/Constriction Index (VDC), Vascular Resistance Index (VR), and Volume Reactivity Index (VRx)-with the crucial physiological indicators, Intracranial Pressure (ICP) and Mean Arterial Pressure (MAP). By doing so, the investigators seek to address fundamental questions surrounding cerebral hemodynamics and autoregulation in various neurological conditions.

Status (registry)
Recruiting
Study type
Observational
Enrollment
25 (estimated)
First submitted
15 Jul 2024
Start date
17 Nov 2024
Primary completion date
30 Dec 2025
Lead sponsor
University of Louisville
NCT number
NCT06511804

What you commit to

  • Study type: Observational
  • Planned participants: 25
  • From 17 Nov 2024 to the primary completion date, 30 Dec 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previously participated in this study, or are enrolled in another research study that could be expected to interfere with participation, in the opinion of the investigator;
  • Ongoing photodynamic therapy.

Other illness

  • Allergy to adhesive tape;

Other

  • Subjects who meet any of the following exclusion criteria will be excluded:
  • Expected to be at increased risk due to study participation (e.g. due to hemodynamic instability), in the medical opinion of an investigator;
  • Pregnant as determined per site standard practice;
  • Require or are anticipated to require emergent medical care in which study participation may reasonably delay his/her medical care or increase risk or unfavorable outcome, in the opinion of the investigator;

Who the study is looking for

  • Subjects who meet all the following inclusion criteria may be included:
  • Adults (\> 18 years of age);
  • Able and willing to provide written informed consent for participation by self or legally authorized representatives.
  • Clinical diagnosis of traumatic brain injury (TBI), brain hemorrhage, brain tumor, neurotrauma (including closed head injuries, penetrating head injuries, or other forms of neurotrauma), hemorrhage (intracerebral or subarachnoid), or stroke.
  • Continuous Blood Pressure Monitoring: Patients must have continuous blood pressure monitoring in place during the study period, obtained from an arterial line. This criterion ensures that we have real-time data on mean arterial pressure (MAP) and systolic pressure (SBP).
  • Intracranial Pressure (ICP) Monitoring: Patients must have intracranial pressure (ICP) monitoring in place during the study period. This criterion ensures that we can assess the correlation between our blood vessel functionality parameters (VDC, VR, and VRx) and ICP, a key indicator of intracranial dynamics.

Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
University of Louisville Health
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LouisvilleUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.