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Pulsatile Perfusion Therapy Phase II

NCT05983744 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2023-08-09

No results posted yet for this study

Summary

Individuals who suffer from a stroke, cardiac arrest, or traumatic bleeding (hemorrhage) injuries often have compromised blood flow and oxygen to the brain which can lead to the death of brain cells, and if the patient survives, subsequent difficulty in thinking and performing tasks of daily living. Traditionally, delivery of a constant flow of blood to the brain has been thought to be the most important factor for the survival of brain cells. In this study, a novel intervention will be assessed called "pulsatile perfusion therapy", delivering blood flow in a slow pulsing pattern. It is anticipated this intervention will improve brain blood flow and oxygenation during these serious clinical events.

There is a specific interest in whether delivery of brain blood flow with a slow pulsatile pattern will improve oxygenation of brain tissue, particularly when the brain is challenged under low oxygen (hypoxia) and low volume (hypovolemia) conditions, simulating stroke, cardiac arrest, and hemorrhage. A technique called oscillatory lower body negative pressure (OLBNP) will be used in healthy human participants, facilitating delivery of blood flow to the brain with different pulsing patterns. This technique will allow for determination of the ideal pattern of brain blood flow that improves oxygenation of the brain tissue. Measurements will be made of substances in the blood that may be released with pulsatile flow which act on the blood vessels to increase flow and delivery of oxygen.

Conditions

Interventions

OTHER

0 Hz Control

Lower body negative pressure (LBNP) applied to -60 mmHg for 10-min

OTHER

0.1 Hz PPT

Lower body negative pressure (LBNP) applied at a frequency of 0.1 Hz from -30 mmHg to -90 mmHg

OTHER

0.05 Hz PPT

Lower body negative pressure (LBNP) applied at a frequency of 0.05 Hz from -30 mmHg to -90 mmHg

Sponsors & Collaborators

  • Caroline Rickards

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-27
Primary Completion
2021-12-17
Completion
2021-12-17

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05983744 on ClinicalTrials.gov