Actively Recruiting
Retrograde Versus Antegrade Perfusion in Low-Moderate Hypothermia for Aortic Arch Surgery
Led by Duke University · Updated on 2025-08-15
30
Participants Needed
2
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to compare brain function after surgical circulatory arrest using either antegrade perfusion or retrograde perfusion.
CONDITIONS
Brief Title
Retrograde Versus Antegrade Perfusion in Low-Moderate Hypothermia for Aortic Arch Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- > 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 will not qualify if you...
- < 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
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Duke Univeristy
Durham, North Carolina, United States, 27710
Not Yet Recruiting
2
Duke Univeristy
Durham, North Carolina, United States, 27710
Actively Recruiting
Research Team
K
Kelly Rodden, BSN
B
Bonita Hilliard, RPM
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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