Retrograde Versus Antegrade Perfusion in Low-Moderate Hypothermia for Aortic Arch Surgery
NCT ID: NCT06986967
Last Updated: 2025-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2025-04-18
2027-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Arm 1: Antegrade 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.
Antegrade Perfusion
Procedure in which the surgeon accesses one of two arteries that branch off from the aorta to provide blood to the brain.
Arm 2: Retrograde Perfusion
In retrograde perfusion, the surgeon accesses the superior vena cava (large vein bringing blood back to the heart) to supply blood to the brain.
Retrograde Perfusion
Procedure in which the surgeon accesses the superior vena cava to supply blood to the brain.
Interventions
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Antegrade Perfusion
Procedure in which the surgeon accesses one of two arteries that branch off from the aorta to provide blood to the brain.
Retrograde Perfusion
Procedure in which the surgeon accesses the superior vena cava to supply blood to the brain.
Eligibility Criteria
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Inclusion Criteria
2. 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
2. history of symptomatic cerebrovascular disease, e.g., prior stroke with residual deficit
3. current alcoholism (\> 2 drinks/day)
4. current psychiatric illness requiring pharmacotherapy
5. current drug abuse (any illicit drug use in the past 3 months)
6. hepatic insufficiency (liver function tests \> 1.5 times the upper limit of normal)
7. severe pulmonary insufficiency (requiring home oxygen therapy)
8. renal failure (serum creatinine \> 2.0 mg/dL)
9. claustrophobic fear
10. unable to read and thus unable to complete the cognitive testing
11. pregnant women
12. patients who score \<19 om the Montreal Cognitive Assessment (MoCA) or ≥27 on the baseline Center for Epidemiological Studies Depression (CES-D) scale
13. patients who have pre-existing unsafe implants for 3 Tesla magnetic resonance imaging (MRI)
14. Patients who have received chemotherapy in the last 12 months or radiation to the brain
18 Years
ALL
No
Sponsors
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Duke University
OTHER
Responsible Party
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Principal Investigators
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Joseph Mathew, M.D.
Role: STUDY_CHAIR
Duke University
Locations
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Duke Univeristy
Durham, North Carolina, United States
Duke Univeristy
Durham, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Pro00116844
Identifier Type: -
Identifier Source: org_study_id
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