Perfusion Techniques for Brain Function in Aortic Valve Replacement

(ACP vs RCP Trial)

Overseen By Bonita Hilliard, RPM

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Must not be taking: Psychiatric drugs, Chemotherapy

Disqualifiers: Stroke, Alcoholism, Drug abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: Up to 7 days

30 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to compare brain function after surgical circulatory arrest using either antegrade perfusion or retrograde perfusion.

Research Team

Joseph Mathew, M.D.

Principal Investigator

Duke University

Eligibility Criteria

This trial is for individuals undergoing aortic arch surgery who require surgical circulatory arrest. Specific eligibility criteria are not provided, but typically participants would need to be suitable candidates for the procedures involved.

Inclusion Criteria

I am over 18 years old.

I am scheduled for surgery on the upper part of my aorta and nearby areas.

Exclusion Criteria

I am currently taking medication for a psychiatric condition.

I need home oxygen therapy due to severe lung problems.

Patients who have pre-existing unsafe implants for 3 Tesla magnetic resonance imaging (MRI)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgical circulatory arrest with either antegrade or retrograde perfusion

Up to 7 days

In-hospital stay

Follow-up

Participants are monitored for cognitive function and brain health post-surgery

4 weeks

MRI at baseline, prior to discharge, and at 4 weeks

Treatment Details

Interventions

• Antegrade Perfusion
• Retrograde Perfusion

Trial Overview The study aims to compare brain function outcomes after aortic arch surgery using two different blood flow techniques: antegrade perfusion (forward flow) and retrograde perfusion (backward flow).

Participant Groups

Group I: Arm 1: Antegrade Perfusion Active Control 1 Intervention

In antegrade perfusion, the surgeon accesses one of two arteries that branch off from the aorta (the artery that delivers blood to the rest of the body) to provide blood to the brain.

Group II: Arm 2: Retrograde Perfusion Active Control 1 Intervention

In retrograde perfusion, the surgeon accesses the superior vena cava (large vein bringing blood back to the heart) to supply blood to the brain.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+