ACP vs RCP Pilot Study (Aorta Surgery) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to compare measures of brain function after surgical circulatory arrest ( when the surgeon stops the heart-lung machine to work on your heart) in antegrade perfusion versus retrograde perfusion. Antegrade and retrograde perfusion are 2 different ways to supply blood to the brain during this type of surgery. 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. In retrograde perfusion, the surgeon accesses the superior vena cava (large vein bringing blood back to the heart) to supply blood to the brain. Both methods are commonly used, but we want to find out if one method works better for most people than the other.

What is the Condition Being Studied?

Aorta Surgery

Who Can Participate in the Study?

Adults ages 18+ who:

  • Are scheduled for elective surgery on the aorta
  • Will undergo a surgery that uses very cold temperatures and circulatory arrest (surgeon stops the heart-lung machine to work on your heart)
  • Do not have more than 2 drinks per day of alcohol
  • Have no history of chronic neurological damage from a stroke

For more information, contact the study team at kelly.rodden@duke.edu.

Age Group
Adults

What is Involved?

If you choose to join this study, you will get a random assignment (like a coin flip) to have either antegrade or retrograde perfusion done during your surgery.

You will have blood draws and MRI imaging done before and after your surgery as a way to collect information about your brain's function.

Study Details

Full Title
Retrograde vs Antegrade Perfusion in Low-Moderate Hypothermia for Aortic Arch Surgery
Principal Investigator
Protocol Number
IRB: PRO00116844
NCT: NCT06986967
Phase
Phase Pilot
ClinicalTrials.gov
Enrollment Status
Open for Enrollment