NCT00606190

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

December 27, 2007

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 1, 2008

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

February 17, 2017

Status Verified

February 1, 2017

Enrollment Period

6.8 years

First QC Date

December 27, 2007

Last Update Submit

February 15, 2017

Conditions

Aneurysm of Aortic Arch

Outcome Measures

Primary Outcomes (1)

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

    6 months

Secondary Outcomes (1)

  • 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.

    6 months

Study Arms (2)

Retrograde brain perfusion

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: Retrograde brain perfusion

Antegrade brain perfusion

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: Antegrade brain perfusion

Interventions

Retrograde brain perfusionPROCEDURE

observational

Retrograde brain perfusion
Antegrade brain perfusionPROCEDURE

observational

Antegrade brain perfusion

Eligibility Criteria

Age21 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Undergoing a total arch replacement
  • Less than 75 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

  • 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.

    PMID: 26409997DERIVED

MeSH Terms

Conditions

Aneurysm, Aortic Arch

Condition Hierarchy (Ancestors)

Aortic Aneurysm, ThoracicAortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • Lars Svensson, MD, PhD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2007

First Posted

February 1, 2008

Study Start

June 1, 2003

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

February 17, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)