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Which way to feed the brain during heart surgery? a trial puts two methods to the test

NCT ID NCT06986967

Disease control Sponsor: Duke University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This trial compares two surgical techniques used to keep the brain supplied with blood during aortic arch surgery, a procedure that requires temporarily stopping blood flow. One method, antegrade perfusion, delivers blood through an artery in the neck. The other, retrograde perfusion, delivers blood through a large vein in the chest. Researchers will measure thinking and memory before and after surgery, and use MRI scans to check for brain changes, to see if one approach better protects brain function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Two surgical brain-protection techniques: antegrade perfusion (blood supplied through an artery in the neck) and retrograde perfusion (blood supplied through a large vein in the chest).
What this could lead to
If one method proves better, it could guide surgeons in choosing the safest way to protect the brain during aortic arch surgery, potentially reducing memory and thinking problems after the operation.
What could go wrong
This is a small, early-stage study with only 30 participants, so results may not apply to all patients. Both techniques carry risks, including stroke or brain injury, and the trial may not find a clear difference.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: 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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Brain function Hemiarch cardiac procedure

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Duke Univeristy

    NOT_YET_RECRUITING

    Durham, North Carolina, 27710, United States

  • Duke Univeristy

    RECRUITING

    Durham, North Carolina, 27710, United States

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