NCT06986967 · Duke University
Retrograde Versus Antegrade Perfusion in Low-Moderate Hypothermia for Aortic Arch Surgery
(ACP vs RCP)
What this study is about
The purpose of this study is to compare brain function after surgical circulatory arrest using either antegrade perfusion or retrograde perfusion.
View original scientific description
The purpose of this study is to compare brain function after surgical circulatory arrest using either antegrade perfusion or retrograde perfusion.
Interventions
PROCEDURE
Antegrade Perfusion
Procedure in which the surgeon accesses one of two arteries that branch off from the aorta to provide blood to the brain.
PROCEDURE
Retrograde Perfusion
Procedure in which the surgeon accesses the superior vena cava to supply blood to the brain.
Primary outcome measures
Change in neurocognitive function as measured by the Montreal Cognitive Assessment (MoCA)
Time frame: Baseline to 4 weeks
The MoCA is a brief screening tool used to assess cognitive function. It consists of 30 tasks covering various cognitive domains, including attention, memory, visuospatial abilities, and executive function. The total score ranges from 0 to 30, where a higher score indicates better cognitive function.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- \> 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 criteria
- \< 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
- Durham, North Carolina
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 15, 2025 · Source of record for eligibility and locations