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Extracorporeal Circulation System

MiECC vs Conventional Bypass for Heart Surgery (MiECS Trial)

N/A

Recruiting

Research Sponsored by Aristotle University Of Thessaloniki

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All patients undergoing any elective or urgent coronary artery bypass grafting (CABG), aortic valve replacement (AVR) or CABG+AVR surgery using extracorporeal circulation without circulatory arrest.

Be older than 18 years old

Must not have

Requirement for major aortic surgery (e.g. aortic root replacement)

Requirement for emergency or salvage operation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days after randomization following the index admission

Awards & highlights

No Placebo-Only Group

Summary

This trial is designed to study whether or not MiECC, as compared to conventional CPB, reduces the proportion of patients experiencing serious perfusion-related postoperative morbidity after cardiac surgery.

Who is the study for?

This trial is for patients needing elective or urgent heart surgery for coronary artery disease or aortic valve issues, using a heart-lung machine but not requiring complex aortic surgery. Participants must be able to consent and can't have blood disorders or objections to blood transfusions.

What is being tested?

The study compares two types of heart-lung machine techniques: the standard method (conventional cardiopulmonary bypass) and a newer, less invasive system (MiECC). The goal is to see if MiECC reduces serious complications after surgery.

What are the potential side effects?

While specific side effects are not listed, potential risks may include those typically associated with heart-lung machines such as inflammation, bleeding, infection risk, organ dysfunction, and reactions related to surgical intervention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for heart surgery involving bypass or valve replacement without stopping my circulation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I need major surgery on my aorta.

Select...

I need an urgent or rescue surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days after randomization following the index admission

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days after randomization following the index admission

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days after randomization following the index admission for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Composite outcome of postoperative serious adverse events

Secondary study objectives

Activated Factor VII administration

Perinatal death

Delirium

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Minimal Invasive Extracorporeal Circulation (MiECC)Active Control1 Intervention

Patients undergoing coronary artery bypass grafting (CABG), aortic valve replacement (AVR), or combined procedure (AVR+CABG) with Minimal Invasive Extracorporeal Circulation (MiECC).

Group II: Conventional Cardiopulmonary Bypass (cCPB)Active Control1 Intervention

Patients undergoing coronary artery bypass grafting (CABG), aortic valve replacement (AVR), or combined procedure (AVR+CABG) with conventional cardiopulmonary bypass (cCPB)

0 / 3Eligibility criteria met