Prospective Randomized Study of Brain Protection During Aortic Arch Replacement

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Robbi Palumbo, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00606190
First received: December 27, 2007
Last updated: January 29, 2014
Last verified: January 2014
  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: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Study of Brain Protection During Aortic Arch Replacement

Resource links provided by NLM:


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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]

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
Other Name: Retrograde brain perfusion
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
Other Name: Antegrade brain perfusion

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

Ages Eligible for Study:   21 Years to 74 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Robbi Palumbo, Nurse Coordinator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00606190     History of Changes
Other Study ID Numbers: 5985 Aortic Arch
Study First Received: December 27, 2007
Last Updated: January 29, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on July 20, 2014