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

ConditionsBrain FunctionHemiarch Cardiac Procedure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDuke University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

> 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

Disqualifiers

< 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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Antegrade Perfusion

    Procedure/Surgery

    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/Surgery

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

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Arm 1: Antegrade PerfusionActive comparator 1 intervention
Group B: Arm 2: Retrograde PerfusionActive comparator 1 intervention

Trial outcomes

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.

Time frame
Baseline to 4 weeks

Secondary outcomes

1

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

Measured by MRI at baseline, prior to discharge, and at 4 weeks.

Time frame
Baseline, prior to discharge from hospital (up to 7 days), and at 4 weeks
2

Effect of Antegrade Perfusion (ACP) vs Retrograde Perfusion (RCP) on functional connectivity

Measured by MRI at baseline and at 4 weeks.

Time frame
Baseline and at 4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke University

Lead sponsor

Source ClinicalTrials.gov
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