Pulsatile Perfusion Therapy Phase II

Completed · Not applicable

Conditions studied: Hemorrhage

In brief

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.

Key facts

Study ID

NCT05983744

Run by

Caroline Rickards

People needed

21

Starts

2020-02-27

Expected to finish

2021-12-17

Last updated by the study team

2023-08-09

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

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
• Signs of cardiovascular abnormalities (e.g., resting systolic blood pressure >140mmHg or diastolic blood pressure >90mmHg; abnormal 12-lead ECG)
• History of cerebrovascular abnormalities (e.g., prior stroke, transient ischemic attacks, epilepsy)
• Known history of atherosclerosis of the carotid arteries (i.e., plaque formation)
• History of concussion and or other loss of consciousness within the preceding month
• Autonomic dysfunction (e.g., Shy-Drager Syndrome, Bradbury-Eggleston syndrome, sinus arrhythmia, idiopathic orthostatic hypotension, fainting disorder)
• Respiratory illnesses (e.g., chronic asthma (including exercise-induced asthma), Chronic Obstructive Pulmonary Disease, Reactive Airway Disease)
• History of anaphylaxis
• Known allergies to medications or other substances (e.g. latex) unless cleared prior to the study
• History of pre-syncopal/syncopal episodes or orthostatic hypotension
• Donated blood within the last 60 days

Where it is running

• University of North Texas Health Science Center — Fort Worth, Texas, United States

Full record on ClinicalTrials.gov

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