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Sponsored by: |
The Cleveland Clinic |
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Information provided by: | The Cleveland Clinic |
ClinicalTrials.gov Identifier: | NCT00606190 |
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 |
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Brain Protection During Total Arch Repair |
Procedure: Repair of Aortic Arch Artery (retrograde brain perfusion) Procedure: Repair of Aortic Arch Artery (antegrade brain perfusion) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
Official Title: | Prospective Randomized Study of Brain Protection During Aortic Arch Replacement |
Estimated Enrollment: | 130 |
Study Start Date: | June 2003 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
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.
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Procedure: Repair of Aortic Arch Artery (retrograde brain perfusion)
observational
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2: Active Comparator
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.
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Procedure: Repair of Aortic Arch Artery (antegrade brain perfusion)
observational
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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 subclavin 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.
Ages Eligible for Study: | 21 Years to 74 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lars Svensson, MD PhD | 216-444-2000 ext 54813 | svenssl@ccf.org |
United States, Ohio | |
Cleveland Clinic | Recruiting |
Cleveland, Ohio, United States, 44195 | |
Contact: Lars Svensson, MD PhD 216-444-2000 ext 54813 svenssl@ccf.org | |
Principal Investigator: Lars Svensson, MD, PhD |
Principal Investigator: | Lars Svensson, MD, PhD | Cleveland Clinic |
Responsible Party: | Cleveland Clinic ( Lars Svensson ) |
Study ID Numbers: | 5985 Aortic Arch |
Study First Received: | December 27, 2007 |
Last Updated: | January 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00606190 History of Changes |
Health Authority: | United States: Institutional Review Board |