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Prospective Randomized Study of Brain Protection During Aortic Arch Replacement

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00606190
First received: December 27, 2007
Last updated: February 15, 2017
Last verified: February 2017

December 27, 2007
February 15, 2017
June 2003
April 2010   (Final data collection date for primary outcome measure)
To determine what is the best method of brain protection during long periods of circulatory arrest [ Time Frame: 6 months ]
Same as current
Complete list of historical versions of study NCT00606190 on ClinicalTrials.gov Archive Site
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 ]
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 ]
Not Provided
Not Provided
 
Prospective Randomized Study of Brain Protection During Aortic Arch Replacement
Prospective Randomized Study of Brain Protection During Aortic Arch Replacement
The purpose of this research study is to evaluate two standard approaches of supplying blood and oxygen to your brain during open heart surgery.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Aneurysm of Aortic Arch
  • Procedure: Retrograde brain perfusion
    observational
  • Procedure: Antegrade brain perfusion
    observational
  • 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.
    Intervention: Procedure: 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.
    Intervention: Procedure: Antegrade brain perfusion
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
123
April 2010
April 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
21 Years to 74 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00606190
5985 Aortic Arch
Yes
Not Provided
No
Not Provided
The Cleveland Clinic
The Cleveland Clinic
Not Provided
Principal Investigator: Lars Svensson, MD, PhD The Cleveland Clinic
The Cleveland Clinic
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP