Pulsatile Perfusion Therapy Phase II

NCT05983744 | Completed

• 1 other identifier: IRB #2019-046
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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

Hemorrhage

Outcome Measures

Primary Outcomes (4)

• Change in ScO2

  Cerebral tissue oxygen saturation

  Up to 3-months

• Change in ICA flow

  Internal carotid artery blood flow

  Up to 3-months

• Change in MCA velocity

  Middle cerebral artery velocity

  Up to 3-months

• Change in circulating vasoactive mediators

  Venous plasma nitric oxide and endothelin

  Up to 3-months

Secondary Outcomes (5)

• Change in arterial pressure

  Up to 3-months

• Change in heart rate

  Up to 3-months

• Change in stroke volume

  Up to 3-months

• Change in PCA velocity

  Up to 3-months

• Change in etO2 and etCO2

  Up to 3-months

Study Arms (1)

Pulsatile perfusion therapy (PPT)

EXPERIMENTAL

Application of oscillatory lower body negative pressure (LBNP) at specific target frequencies of interest.

Other: 0 Hz Control; Other: 0.1 Hz PPT; Other: 0.05 Hz PPT

Interventions

0 Hz Control OTHER

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

Pulsatile perfusion therapy (PPT)

0.1 Hz PPT OTHER

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

Pulsatile perfusion therapy (PPT)

0.05 Hz PPT OTHER

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

Pulsatile perfusion therapy (PPT)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 18 to 40 years
• Non-tobacco/nicotine users (e.g., cigarettes (including electronic cigarettes), chewing tobacco, nicotine gum or patches)
• Systolic arterial pressure \<140 mmHg; diastolic arterial pressure \<90 mmHg
• Normal 12-lead ECG (reviewed by a physician)
• Normal clinical results from a medical exam reviewed by a board certified physician (e.g., General Health Questionnaire - see attached document)
• Easily visualized internal carotid and vertebral arteries (via Doppler ultrasound) for accurate measurement of velocity and diameter.
• Body mass index (BMI) \<30 kg/m2 unless athletic/muscular build; calculation = body weight (kg)/height (m2); this criteria is used to ensure subjects will fit inside the LBNP chamber
• Females only: documentation of a negative pregnancy test prior to the familiarization and experimental sessions

You may not qualify if:

• Age \<18 or \>40 years
• Use of tobacco/nicotine within the last 6 months (e.g., cigarettes (including electronic cigarettes), chewing tobacco, nicotine gum or patches)
• Body mass index (BMI) \>30 kg/m2 unless athletic/muscular build; calculation = body weight (kg)/height (m2)
• Not abstaining from the following 24 hours prior to the experimental session: exercise, alcoholic substances, prescription or non-prescription medications (unless cleared by the medical screener), dietary supplements, herbal medications, caffeinated substances (including coffee, tea (iced or hot), caffeinated energy drinks or sodas).
• Inability to visualize the internal carotid and vertebral arteries (via Doppler ultrasound) for accurate measurement of velocity and diameter.
• Positive pregnancy test
• Post-menopausal females
• Females with an erratic/irregular menstrual cycle
• Use of prescription drugs, non-prescription drugs or herbal medicines known to alter cardiovascular, autonomic, or cerebrovascular function unless cleared prior to the study
• Use of anti-hypertensive medications
• Use of beta blockers
• Frequent use of bronchodilators (occasional use, i.e. seasonally, is allowable)
• Use of anti-coagulant therapy
• Use of non-contraceptive related hormone therapy
• Current or past history of hyperthyroidism, or other thyroid hormone-related disease

Sponsors & Collaborators

• Caroline Rickards: lead

Study Sites (1)

University of North Texas Health Science Center

Fort Worth, Texas, 76107, United States

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: August 9, 2023
• Study Start: February 27, 2020
• Primary Completion: December 17, 2021
• Study Completion: December 17, 2021
• Last Updated: August 9, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Starting 6 months after publication.

Locations

US (1)