Retrograde Versus Antegrade Perfusion in Low-Moderate Hypothermia for Aortic Arch Surgery

Recruiting now · Not applicable

Conditions studied: Brain Function, Hemiarch Cardiac Procedure

In brief

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

Key facts

Study ID

NCT06986967

Run by

Duke University

People needed

30

Starts

2025-04-18

Expected to finish

2027-03-01

Last updated by the study team

2025-08-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• > 18 years of age
• Participant's that are scheduled for elective proximal aortic reconstructive surgery (ascending aorta + aortic valve or root) with concomitant proximal hemi-arch replacement via median sternotomy

You may not qualify if…

• < 18 years of age
• history of symptomatic cerebrovascular disease, e.g., prior stroke with residual deficit
• current alcoholism (> 2 drinks/day)
• current psychiatric illness requiring pharmacotherapy
• current drug abuse (any illicit drug use in the past 3 months)
• hepatic insufficiency (liver function tests > 1.5 times the upper limit of normal)
• severe pulmonary insufficiency (requiring home oxygen therapy)
• renal failure (serum creatinine > 2.0 mg/dL)
• claustrophobic fear
• unable to read and thus unable to complete the cognitive testing
• pregnant women
• patients who score <19 om the Montreal Cognitive Assessment (MoCA) or ≥27 on the baseline Center for Epidemiological Studies Depression (CES-D) scale
• patients who have pre-existing unsafe implants for 3 Tesla magnetic resonance imaging (MRI)
• Patients who have received chemotherapy in the last 12 months or radiation to the brain

Where it is running

• Duke Univeristy — Durham, North Carolina, United States (enrolling)
• Duke Univeristy — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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