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Completed

NCT Number: NCT00606190

Prospective Randomized Study of Brain Protection During Aortic Arch Replacement

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

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Key information

Conditions

Aneurysm of Aortic Arch Aneurysm Aneurysm, Aortic Arch Aortic Aneurysm Aortic Aneurysm, Thoracic Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

21 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Retrograde brain perfusion

Procedure

observational

Antegrade brain perfusion

Procedure

observational

Primary outcomes

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

    Time frame: 6 months

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Important dates

Study start
2003
Primary completion
2010
Study completion
2010
First posted
Feb 1, 2008
Registry last updated
Feb 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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