Retrograde Versus Antegrade Perfusion in Low-Moderate Hypothermia for Aortic Arch Surgery

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT06986967
Status
Recruiting

Conditions

  • Brain Function
  • Hemiarch Cardiac Procedure

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Antegrade Perfusion — PROCEDURE
    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
    Procedure in which the surgeon accesses the superior vena cava to supply blood to the brain.

Study Details

The purpose of this study is to compare brain function after surgical circulatory arrest using either antegrade perfusion or retrograde perfusion.

Key Dates

Start date
Apr 18, 2025
Status verified
Aug 2025
Primary completion
Dec 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Change in neurocognitive function as measured by the Montreal Cognitive Assessment (MoCA) [ Time Frame: Baseline to 4 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Duke UniveristyDurhamNorth Carolina27710
Kelly Rodden, BSN
919-681-1804
Duke UniveristyDurhamNorth Carolina27710
Kelly Dr. Mathew, MD
919-681-1804

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