Prospective Randomized Study of Brain Protection During Aortic Arch Replacement

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

Detailed Description
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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.

Official Title
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Prospective Randomized Study of Brain Protection During Aortic Arch Replacement

Conditions
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Aneurysm of Aortic Arch

Intervention / Treatment
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* Procedure: Retrograde brain perfusion
* Procedure: Antegrade brain perfusion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Retrograde brain perfusion<br>Pt may be randomized to retrograde brain perfusion when having a repair of the ascending aortic artery (aorta) including the aortic arch. This is one of the standard methods used while the body and the brain are cooled down to sub-normal levels (hypothermia). This will take place while on the heart-lung machine. | Procedure: Retrograde brain perfusion<br>* observational<br>|
| Active Comparator: Antegrade brain perfusion<br>Pt may be randomized to antegrade brain perfusion when having a repair of the ascending aortic artery (aorta) including the aortic arch. This is one of the standard methods used while the body and the brain are cooled down to sub-normal levels (hypothermia). This will take place while on the heart-lung machine. | Procedure: Antegrade brain perfusion<br>* observational<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine what is the best method of brain protection during long periods of circulatory arrest |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 6 months |