Prospective Randomized Study of Brain Protection During Arotic Arch Replacement - Full Text View

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
Brain Protection During Total Arch Repair	Procedure: Repair of Ascending Aortic Artery Including the Arch (retrograde brain perfusion) Procedure: Repair of Ascending Aortic Artery Including the Arch (antegrade brain perfusion)

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment

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 ] [ 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 neurobrhabioural deficit at 6 monuths postop. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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
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.	Procedure: Repair of Ascending Aortic Artery Including the Arch (retrograde brain perfusion) observational
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.	Procedure: Repair of Ascending Aortic Artery Including the Arch (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 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.

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 promary 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00606190

Contacts


Contact: Lars Svensson, MD PhD	216-444-2000 ext 54813	svenssl@ccf.org

Locations


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

Sponsors and Collaborators

The Cleveland Clinic

Investigators


Principal Investigator:	Lars Svensson, MD, PhD	Cleveland Clinic

More Information

Responsible Party:	Cleveland Clinic ( Lars Svensson )
Study ID Numbers:	5985 Aortic Arch
First Received:	December 27, 2007
Last Updated:	February 1, 2008
ClinicalTrials.gov Identifier:	NCT00606190
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 06, 2008

Sponsored by:	The Cleveland Clinic
Information provided by:	The Cleveland Clinic
ClinicalTrials.gov Identifier:	NCT00606190