Prospective Randomized Study of Brain Protection During Aortic Arch Replacement

NeuroTherapia, Inc.

Status: Completed

Conditions: Aneurysm of Aortic Arch

Treatments: Procedure: Antegrade brain perfusion; Procedure: Retrograde brain perfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT00606190

5985 Aortic Arch

Details and patient eligibility

About

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

Full 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.

Enrollment: 123 patients

Sex: All

Ages: 21 to 74 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

123 participants in 2 patient groups

Retrograde brain perfusion

Active Comparator group

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.

Treatment:

Procedure: Retrograde brain perfusion

Antegrade brain perfusion

Active Comparator group

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.

Treatment:

Procedure: Antegrade brain perfusion