Prospective Randomized Study of Brain Protection During Aortic Arch Replacement

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00606190

Enrollment

123

Registered

2008-02-01

Start date

2003-06-30

Completion date

2010-04-30

Last updated

2017-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aneurysm of Aortic Arch

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.

Interventions

PROCEDURERetrograde brain perfusion

observational

PROCEDUREAntegrade brain perfusion

observational

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 74 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
To determine what is the best method of brain protection during long periods of circulatory arrest	6 months

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026