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Could a softer Heart-Lung machine protect the brain during surgery?

NCT ID NCT07661238

Knowledge-focused Sponsor: Bursa Yuksek Ihtisas Training and Research Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a newer, less invasive heart-lung machine (MiECC) reduces brain swelling and stroke risk compared to the standard machine used during open heart surgery. Researchers will measure optic nerve sheath diameter (a marker of brain pressure) and track strokes over 30 days in 100 adults undergoing elective heart surgery. The goal is to see if MiECC offers better brain protection.

What this could mean

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

Active substance
Minimally Invasive Extracorporeal Circulation (MiECC)
What this could lead to
If MiECC reduces brain-related complications like stroke or swelling, it could become a safer standard for heart surgery.
What could go wrong
This is a single-center trial with 100 participants, so results may not apply broadly. The study measures early signs, not long-term outcomes.

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.

Participants

About 100 people

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

Started

Nov 2025

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Who is studied

,elective 18-80 aged, coronary bypass surgery patients with pump convansionel and MIECC

Ages

18 to 80 years

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: * Age 18 to 80 years * Scheduled for elective isolated open heart surgery * Requires cardiopulmonary bypass * Able to provide written informed consent * Adequate ultrasonographic window for ONSD measurement Exclusion Criteria: * Emergency or salvage surgery * Off-pump, revision, or combined cardiac surgery * History of stroke or TIA within the last 6 months * Pre-existing neurological deficit * Bilateral optic nerve pathology * History of ocular trauma or surgery * Intracranial mass or hydrocephalus * Requirement for deep hypothermic circulatory arrest * Alcohol or substance dependency * Left ventricular ejection fraction \<30% * Renal or hepatic failure with risk of advanced encephalopathy * Preoperative requirement for mechanical circulatory support * Symptomatic or severe carotid artery stenosis (\>70%) * Refusal to participate in the study

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Conditions

The condition(s) this trial relates to.

stroke disorder

As listed by the trial registrant

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

Cardiac surgery Cardiopulmonary bypass Stroke

Contacts and locations

Locations

  • University of Health Sciences Bursa Yüksek Ihtisas Training and Research Hospital

    Bursa, Yıldırım, 16600, Turkey (Türkiye)

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