Brain FunctionACP vs RCPNCT06986967
Retrograde Versus Antegrade Perfusion in Low-Moderate Hypothermia for Aortic Arch Surgery
A study testing Antegrade Perfusion and Retrograde Perfusion in people with Brain Function and Hemiarch Cardiac Procedure, run by Duke University at 2 sites in United States.
Trial summary
The purpose of this study is to compare brain function after surgical circulatory arrest using either antegrade perfusion or retrograde perfusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Function, Hemiarch Cardiac Procedure
- What is being tested?
- Antegrade Perfusion and Retrograde Perfusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Apr 2025to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 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
Who cannot join
- < 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)
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Bonita Hilliard, RPM contact
United States2 sites, 2 recruiting
- Not yet recruiting
Duke Univeristy
Durham, North Carolina, 27710
Kelly Rodden, BSN, 9196811804, Kelly.Rodden@duke.edu
- Recruiting
Duke Univeristy
Durham, North Carolina, 27710
Kelly Dr. Mathew, MD, 9196811804, joseph.mathew@duke.edu
About this study
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.
- Conditions
- Brain Function, Hemiarch Cardiac Procedure
- Being tested
- Antegrade Perfusion, Retrograde Perfusion
- Keywords
- Antegrade Perfusion, Retrograde Perfusion, Brain Perfusion, Circulatory Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antegrade PerfusionProcedure or surgery
Procedure in which the surgeon accesses one of two arteries that branch off from the aorta to provide blood to the brain.
Retrograde PerfusionProcedure or surgery
Procedure in which the surgeon accesses the superior vena cava to supply blood to the brain.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Retrograde Perfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 4 weeks
Secondary outcomes (2)
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.
Measured: 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
Measured by MRI at baseline and at 4 weeks.
Measured: Baseline and at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start18 Apr 2025
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain FunctionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph Mathew, M.D., Study chair, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06986967
- Sponsor's protocol ID
- Pro00116844
- Acronym
- ACP vs RCP
- Status last verified
- Aug 2026
- First submitted
- 29 Apr 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrograde Versus Antegrade Perfusion in Low-Moderate Hypothermia for Aortic Arch Surgery
- ClinicalTrials.gov ID
- NCT06986967
- Acronym / sponsor ID
- ACP vs RCP / Pro00116844
- Conditions
- Brain Function, Hemiarch Cardiac Procedure
- Keywords
- Antegrade Perfusion, Retrograde Perfusion, Brain Perfusion, Circulatory Arrest
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 18 Apr 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 23 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare brain function after surgical circulatory arrest using either antegrade perfusion or retrograde perfusion.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Antegrade Perfusion | Active comparator | Procedure: Antegrade PerfusionIn 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. |
| Arm 2: Retrograde Perfusion | Active comparator | Procedure: Retrograde PerfusionIn retrograde perfusion, the surgeon accesses the superior vena cava (large vein bringing blood back to the heart) to supply blood to the brain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- > 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
Key exclusion criteria (14 listed)
- < 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antegrade PerfusionProcedure in which the surgeon accesses one of two arteries that branch off from the aorta to provide blood to the brain. | Procedure or surgery | Arm 1: Antegrade Perfusion |
| Retrograde PerfusionProcedure in which the surgeon accesses the superior vena cava to supply blood to the brain. | Procedure or surgery | Arm 2: Retrograde Perfusion |
Primary outcome
Change in neurocognitive function as measured by the Montreal Cognitive Assessment (MoCA)
Time frame: Baseline to 4 weeks
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.
2 secondary outcomes
Effect of Antegrade Perfusion (ACP) vs Retrograde Perfusion (RCP) on brain white matter patency
Time frame: 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
Time frame: Baseline and at 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bonita Hilliard, RPM contact
Joseph Mathew, M.D. study chair
Duke University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antegrade Perfusion and Retrograde Perfusion in people with Brain Function and Hemiarch Cardiac Procedure, run by Duke University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelly Rodden, BSN (9196811804, Kelly.Rodden@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in neurocognitive function as measured by the Montreal Cognitive Assessment (MoCA) (time frame: Baseline to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.