RecruitingNot ApplicableNCT06986967
Retrograde Versus Antegrade Perfusion in Low-Moderate Hypothermia for Aortic Arch Surgery
Sponsor
Duke University
Enrollment
30 participants
Start Date
Apr 18, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to compare brain function after surgical circulatory arrest using either antegrade perfusion or retrograde perfusion.
Eligibility
Min Age: 18 Years
Inclusion Criteria2
- > 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
Exclusion Criteria14
- < 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
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Interventions
PROCEDUREAntegrade Perfusion
Procedure in which the surgeon accesses one of two arteries that branch off from the aorta to provide blood to the brain.
PROCEDURERetrograde Perfusion
Procedure in which the surgeon accesses the superior vena cava to supply blood to the brain.
Locations(2)
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NCT06986967
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