Prospective Randomized Study of Brain Protection During Aortic Arch Replacement

The Cleveland Clinic123 enrolled

Overview

The purpose of this research study is to evaluate two standard approaches of supplying blood and oxygen to your brain during open heart surgery.

The purpose of the clinical trial is to assess the best method of protecting the brain during long periods of circulatory arrest. The significance of this project will be to determine which method of brain protection (1) retrograde brain perfusion or (2) perfusion of the right subclavian artery with antegrade perfusion of the brain protects against brain injury after total arch replacement. Thus reducing the risk of stroke or neurocognitive deficits in patients undergoing this critical surgical procedure.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

123

Conditions

Aneurysm of Aortic Arch

Interventions

Retrograde brain perfusionPROCEDURE

observational

Antegrade brain perfusionPROCEDURE

observational

Eligibility

Sex: ALLMin age: 21 YearsMax age: 74 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Undergoing a total arch replacement * Less than 75 years old Exclusion Criteria: * EF less than 35% * Pt shows evidence of major illness e.g. severe hepatic disease, severe renal failure, active cancer or major infection * Pt unable to complete preop neuro assessment * Pt is unwilling or able to complete followup requirements * Pt is already enrolled in other new device or drug protocols that have not completed the primary endpoint or that clinically interferes with study endpoint * Pt is a female who is pregnant or lactating * Pt has history of stroke

Locations (1)

Cleveland Clinic

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

To determine what is the best method of brain protection during long periods of circulatory arrest

Time frame: 6 months

Secondary Outcomes

Will one method of brain protection be better than the other in prevention of post-op stroke and which method will provide freedom from postop neurobehavioural deficit at 6 months postop.

Time frame: 6 months

Data from ClinicalTrials.gov

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