Retrograde Versus Antegrade Perfusion in Low-Moderate Hypothermia for Aortic Arch Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Antegrade Perfusion, Retrograde Perfusion.
- Who it may be relevant to
- Registry conditions: Brain Function, Hemiarch Cardiac Procedure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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. There are 2 ways to supply blood to the brain, antegrade and retrograde perfusion. In antegrade perfusion, the surgeon accesses one of two arteries that branch off from the aorta (the artery that delivers blood to the rest of the body) to provide blood to the brain. In retrograde perfusion, the surgeon accesses the superior vena cava (large vein bringing blood back to the heart) to supply blood to the brain.
It is standard practice to cool the patient down during this type of surgery to help protect the brain. Despite measures to safeguard brain health, some patients still experience postoperative cognitive decline such as confusion, delirium and agitation. The investigators are conducting this study to see which method of perfusing the brain is superior and decreases the symptoms of confusion, delirium and agitation.
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]
Secondary outcome measures (2)
- Effect of Antegrade Perfusion (ACP) vs Retrograde Perfusion (RCP) on brain white matter patency [Time frame: Baseline, prior to discharge from hospital (up to 7 days), and at 4 weeks]
- Effect of Antegrade Perfusion (ACP) vs Retrograde Perfusion (RCP) on functional connectivity [Time frame: Baseline and at 4 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 2 centers
- Duke Univeristy — Durham
- Duke Univeristy — Durham
Identifiers
NCT: NCT06986967 · Pro00116844