Comparison of Minimal Versus Conventional Extracorporeal Circulation in Coronary Surgery

January 11, 2021 updated by: Kyriakos Anastasiadis, AHEPA University Hospital

Research on Remote End-organ Protection, Clinical Outcome and Quality of Life With Implementation of the Novel Minimal Extracorporeal Circulation Circuit in Open Heart Surgery

The aim of this study is to assess the effect of minimal (MiECC) versus conventional (CECC) extracorporeal circulation on perfusion characteristics and remote end-organ protection (lungs, brain, kidneys, liver, stomach, intestine), after elective coronary bypass grafting (CABG).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to investigate whether coronary surgery with minimal Invasive Extracorporeal Circulation (MiECC) offers advantage over conventional CPB (CECC). In order to draw an evidence-based conclusion, the investigators aim to evaluate perfusion characteristics during coronary surgery with MECC and associated remote end-organ function. Improved end-organ protection translates into improved clinical outcome which greatly affects quality of life. This is the first study in the literature adequately powered to analyse organ pathophysiology during surgery with MECC and at the same time correlating common clinical variables with a detailed quality of life evaluation. Superiority of MECC could provide firm evidence towards widespread use of MECC in coronary surgery as standard of care.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Thessaloniki, Greece
        • Cardiothoracic Department, AHEPA University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients scheduled for elective coronary artery bypass grafting

Exclusion Criteria:

  • history of psychiatric disorder
  • inability to undergo neuropsychological assessment
  • history of transient ischemic attack or stroke
  • carotid artery stenosis > 60% assessed by duplex ultrasonography

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: MiECC group
Patients operated for elective coronary artery bypass grafting with the use of minimal invasive extracorporeal circulation (MiECC).
Procedure: Coronary artery bypass grafting with the use of minimal invasive extracorporeal circulation
We use a prototype AHEPA (modular type IV) circuit comprised of the standard and a standby accessory. Components of the standard circuit include: aortic cannula, three-stage venous cannula, coated tubing, a centrifugal pump, a new-generation membrane oxygenator with integrated arterial filter, a venous air removal device, a soft coated bag and pulmonary artery as well as aortic root vent. In addition, there is a standby hard-shell reservoir in parallel to the venous line, so as to convert the closed system to an open one. The standby component is bridged to the main circuit with an afferent line which is connected just before the VARD sending blood to the hard-shell reservoir and an efferent that re-directs it back to the VARD. A cell-saver device is added to the circuit for collecting shed blood and washing red blood cells for autotransfusion.
Active Comparator: CECC group
Patients operated for elective coronary artery bypass grafting under conventional extracorporeal circulation (CECC).
Procedure: Coronary artery bypass grafting under conventional extracorporeal circulation
A standard open CPB circuit is used, consisting of uncoated PVC tubing, a hard-shell venous reservoir, a microporous membrane oxygenator (Dideco, Mirandola, Italy) and a roller pump (Stöckert S3, Munich, Germany). The circuit contains a 40 μm arterial line blood filter (Dideco, Mirandola, Italy) and it is primed with 1500 mL of a balanced crystalloid/colloid solution (1000 mL of Ringer's solution, 200 mL of mannitol 20%, and 300 mL of hydroxyethyl starch 6%). Cardiotomy as well as sump sucker are integrated to the circuit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Remote end-organ perfusion and function (brain, lungs, liver, kidneys, stomach, intestine) intraoperatively and postoperatively during hospital stay
Time Frame: 30 days
Remote end-organ perfusion and function at 30 days follow-up after elective coronary artery bypass grafting with the use of minimal (MiECC) versus conventional (CECC) extracorporeal circulation.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative major adverse cardiac and cerebrovascular events (MACCE) that comprise: myocardial infarction, low cardiac output syndrome, stroke, renal failure.
Time Frame: 30 days
Postoperative major adverse cardiac and cerebrovascular events (MACCE) that comprise: myocardial infarction, low cardiac output syndrome, stroke, renal failure at 30 days follow-up after elective coronary artery bypass grafting with the use of minimal (MiECC) versus conventional (CECC) extracorporeal circulation.
30 days
Duration of mechanical ventilation
Time Frame: 30 days
Duration of mechanical ventilation at 30 days follow-up after elective coronary artery bypass grafting with the use of minimal (MiECC) versus conventional (CECC) extracorporeal circulation.
30 days
Length of ICU stay
Time Frame: 30 days
Length of ICU stay at 30 days follow-up after elective coronary artery bypass grafting with the use of minimal (MiECC) versus conventional (CECC) extracorporeal circulation.
30 days
Development of new postoperative atrial fibrillation.
Time Frame: 30 days
Development of new postoperative atrial fibrillation at 30 days follow-up after elective coronary artery bypass grafting with the use of minimal (MiECC) versus conventional (CECC) extracorporeal circulation.
30 days
Neurocognitive function
Time Frame: 6 months postoperatively
Neurocognitive evaluation with a battery of specialized tests performed by a dedicated and experienced team in clinical psychology. Evaluation will be performed at specific time intervals: preoperatively, at 1-, 3- and 6-month follow-up.
6 months postoperatively
Health-related quality of life
Time Frame: 6 months postoperatively
Change in quality of life assessed with SF-36 questionnaire after coronary artery bypass grafting with minimal versus conventional extracorporeal circulation.
6 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AHEPA University Hospital

Investigators

  • Principal Investigator: Kyriakos Anastasiadis, MD, PhD, FETCS, Cardiothoracic Department, AHEPA University Hospital, Thessaloniki, Greece

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

May 21, 2012

First Submitted That Met QC Criteria

May 21, 2012

First Posted (Estimate)

May 22, 2012

Study Record Updates

Last Update Posted (Actual)

January 12, 2021

Last Update Submitted That Met QC Criteria

January 11, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AHEPA_CTS_04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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