Prospective Randomized Study of Brain Protection During Aortic Arch Replacement

Aneurysm of Aortic Arch Clinical Trial

Official title:

Prospective Randomized Study of Brain Protection During Aortic Arch Replacement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00606190
• Other study ID #: 5985 Aortic Arch
• Status: Completed
• Phase: N/A
• First received: December 27, 2007
• Last updated: February 15, 2017
• Start date: June 2003
• Est. completion date: April 2010

Study information

• Verified date: February 2017
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm of Aortic Arch

Intervention

Procedure:
• Retrograde brain perfusion
observational
• Antegrade brain perfusion
observational

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine what is the best method of brain protection during long periods of circulatory arrest		6 months
Secondary	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