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)

Duke Univeristy

Durham, North Carolina, United States

Duke Univeristy

Durham, North Carolina, United States

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NCT06986967


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