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RecruitingNCT06986967ACP vs RCPUpdated Sep 3, 2026

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

An interventional study of Antegrade Perfusion and Retrograde Perfusion in Brain Function and Hemiarch Cardiac Procedure, sponsored by Duke University. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.

Sponsored by Duke University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Apr 2025; still recruiting 1 year 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Brain Function
  • Hemiarch Cardiac Procedure

Keywords

  • Antegrade Perfusion
  • Retrograde Perfusion
  • Brain Perfusion
  • Circulatory Arrest
03

In context

Lead sponsor

Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.

Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. > 18 years of age
  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

Exclusion Criteria:

  1. \< 18 years of age
  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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
30 participants (estimated)

Study 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.

    Procedure: Antegrade Perfusion

  • 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.

    Procedure: Retrograde Perfusion

Interventions

  • ProcedureAntegrade Perfusion

    Procedure in which the surgeon accesses one of two arteries that branch off from the aorta to provide blood to the brain.

  • ProcedureRetrograde Perfusion

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

06

What researchers measure

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

07

Study locations

1 of 2 sites recruiting
  • Duke Univeristy
    Durham, North Carolina 27710, United States
    Not yet recruiting
  • Duke Univeristy
    Durham, North Carolina 27710, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06986967
Lead sponsor
Duke University
Responsible party
Sponsor
First posted
May 23, 2025
Start date
Apr 18, 2025
Primary completion
Dec 2026 (estimated)
Completion
Mar 2027 (estimated)
Last update
Sep 3, 2026

Study contacts

Kelly Rodden, BSN
Contact
Kelly.Rodden@duke.edu
9196811804
Bonita Hilliard, RPM
Contact
bonita.hilliard@duke.edu
Joseph Mathew, M.D.
study chair · Duke University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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