Prospective Randomized Study of Brain Protection During Aortic Arch Replacement
NCT ID: NCT00606190
Last Updated: 2017-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
123 participants
INTERVENTIONAL
2003-06-30
2010-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Retrograde brain perfusion
observational
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.
Antegrade brain perfusion
observational
Interventions
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Retrograde brain perfusion
observational
Antegrade brain perfusion
observational
Eligibility Criteria
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Inclusion Criteria
* Less than 75 years old
Exclusion Criteria
* 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
21 Years
74 Years
ALL
Yes
Sponsors
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The Cleveland Clinic
OTHER
Responsible Party
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Principal Investigators
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Lars Svensson, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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Cleveland Clinic
Cleveland, Ohio, United States
Countries
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References
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Svensson LG, Blackstone EH, Apperson-Hansen C, Ruggieri PM, Ainkaran P, Naugle RI, Lima B, Roselli EE, Cooper M, Somogyi D, Tuzcu EM, Kapadia S, Clair DG, Sabik JF 3rd, Lytle BW. Implications from neurologic assessment of brain protection for total arch replacement from a randomized trial. J Thorac Cardiovasc Surg. 2015 Nov;150(5):1140-7.e11. doi: 10.1016/j.jtcvs.2015.07.054. Epub 2015 Jul 26.
Other Identifiers
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5985 Aortic Arch
Identifier Type: -
Identifier Source: org_study_id
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