Status:
RECRUITING
Retrograde Versus Antegrade Perfusion in Low-Moderate Hypothermia for Aortic Arch Surgery
Lead Sponsor:
Duke University
Conditions:
Brain Function
Hemiarch Cardiac Procedure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to compare brain function after surgical circulatory arrest using either antegrade perfusion or retrograde perfusion.
Detailed Description
The purpose of this study is to compare brain function after surgical circulatory arrest (surgeon stops the heart-lung machine to work on the heart) in antegrade perfusion versus retrograde perfusion....
Eligibility Criteria
Inclusion
- \> 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
- \< 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
Key Trial Info
Start Date :
April 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06986967
Start Date
April 18 2025
End Date
March 1 2027
Last Update
August 15 2025
Active Locations (2)
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1
Duke Univeristy
Durham, North Carolina, United States, 27710
2
Duke Univeristy
Durham, North Carolina, United States, 27710