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

NCT06986967 | Recruiting

• 1 other identifier: Pro00116844
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Brain Function; Hemiarch Cardiac Procedure

Keywords

Antegrade Perfusion; Retrograde Perfusion; Brain Perfusion; Circulatory Arrest

Outcome Measures

Primary Outcomes (1)

• Change in neurocognitive function as measured by the Montreal Cognitive Assessment (MoCA)

  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.

  Baseline to 4 weeks

Secondary Outcomes (2)

• Effect of Antegrade Perfusion (ACP) vs Retrograde Perfusion (RCP) on brain white matter patency

  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

  Baseline and at 4 weeks

Study Arms (2)

Arm 1: Antegrade Perfusion

ACTIVE COMPARATOR

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.

Procedure: Antegrade Perfusion

Arm 2: Retrograde Perfusion

ACTIVE COMPARATOR

In retrograde perfusion, the surgeon accesses the superior vena cava (large vein bringing blood back to the heart) to supply blood to the brain.

Procedure: Retrograde Perfusion

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.

Arm 1: Antegrade Perfusion

Retrograde Perfusion PROCEDURE

Procedure in which the surgeon accesses the superior vena cava to supply blood to the brain.

Arm 2: Retrograde Perfusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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 may not qualify if:

• \< 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (2)

Duke Univeristy

Durham, North Carolina, 27710, United States

NOT YET RECRUITING

Duke Univeristy

Durham, North Carolina, 27710, United States

RECRUITING

Study Officials

• Joseph Mathew, M.D.

  Duke University

  STUDY CHAIR

Central Study Contacts

Kelly Rodden, BSN

CONTACT

9196811804; Kelly.Rodden@duke.edu

Bonita Hilliard, RPM

CONTACT

bonita.hilliard@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The neuroimaging personnel will be blinded to the assignment of the subject.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 23, 2025
• Study Start: April 18, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

US (2)