Prospective Randomized Study of Brain Protection During Aortic Arch Replacement

Not Applicable

Completed

• Conditions: Aneurysm of Aortic Arch
• Interventions: Procedure: Retrograde brain perfusion; Procedure: Antegrade brain perfusion

• Registration Number: NCT00606190
• Lead Sponsor: The Cleveland Clinic

Brief Summary

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

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 Timeline

• Study Start: 2003-06
• Study First Submitted: 2007-12-27
• Study First Submitted QC: 2008-01-31
• Study First Posted: 2008-02-01
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-15
• Last Update Posted: 2017-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Retrograde brain perfusion	Retrograde brain perfusion	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.
Antegrade brain perfusion	Antegrade brain perfusion	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.

Primary Outcome Measures

Name	Time	Method
To determine what is the best method of brain protection during long periods of circulatory arrest	6 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States