We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prospective Randomized Study of Brain Protection During Aortic Arch Replacement

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00606190
First Posted: February 1, 2008
Last Update Posted: February 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
The Cleveland Clinic
  Purpose
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 Intervention
Aneurysm of Aortic Arch Procedure: Retrograde brain perfusion Procedure: Antegrade brain perfusion

Study Type: Interventional
Study Design: 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

Further study details as provided by The Cleveland Clinic:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 123
Study Start Date: June 2003
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

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 Submitted: December 27, 2007
First Posted: February 1, 2008
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