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Prospective Randomized Study of Brain Protection During Aortic Arch Replacement

Primary Purpose

Aneurysm of Aortic Arch

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Retrograde brain perfusion
Antegrade brain perfusion
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aneurysm of Aortic Arch

Eligibility Criteria

21 Years - 74 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cleveland Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Retrograde brain perfusion

Antegrade brain perfusion

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

To determine what is the best method of brain protection during long periods of circulatory arrest

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.

Full Information

First Posted
December 27, 2007
Last Updated
February 15, 2017
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT00606190
Brief Title
Prospective Randomized Study of Brain Protection During Aortic Arch Replacement
Official Title
Prospective Randomized Study of Brain Protection During Aortic Arch Replacement
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this research study is to evaluate two standard approaches of supplying blood and oxygen to your brain during open heart surgery.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aneurysm of Aortic Arch

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Retrograde brain perfusion
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Antegrade brain perfusion
Arm Type
Active Comparator
Arm Description
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 Type
Procedure
Intervention Name(s)
Retrograde brain perfusion
Intervention Description
observational
Intervention Type
Procedure
Intervention Name(s)
Antegrade brain perfusion
Intervention Description
observational
Primary Outcome Measure Information:
Title
To determine what is the best method of brain protection during long periods of circulatory arrest
Time Frame
6 months
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Svensson, MD, PhD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26409997
Citation
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.
Results Reference
derived

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Prospective Randomized Study of Brain Protection During Aortic Arch Replacement

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