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Prospective Randomized Study of Brain Protection During Aortic Arch Replacement

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ClinicalTrials.gov Identifier: NCT00606190
Recruitment Status : Completed
First Posted : February 1, 2008
Last Update Posted : February 17, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Aneurysm of Aortic Arch Procedure: Retrograde brain perfusion Procedure: Antegrade brain perfusion Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Study of Brain Protection During Aortic Arch Replacement
Study Start Date : June 2003
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Arm Intervention/treatment
Active Comparator: 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.
Procedure: Retrograde brain perfusion
observational
Active Comparator: 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.
Procedure: Antegrade brain perfusion
observational



Primary Outcome Measures :
  1. To determine what is the best method of brain protection during long periods of circulatory arrest [ Time Frame: 6 months ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00606190


Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Lars Svensson, MD, PhD The Cleveland Clinic

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00606190     History of Changes
Other Study ID Numbers: 5985 Aortic Arch
First Posted: February 1, 2008    Key Record Dates
Last Update Posted: February 17, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Aneurysm
Vascular Diseases
Cardiovascular Diseases