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NCT Number: NCT01603589

Comparison of Minimal Versus Conventional Extracorporeal Circulation in Coronary 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).

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Key information

Conditions

Coronary Artery Bypass Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiothoracic Department, AHEPA University Hospital

Thessaloniki, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coronary artery bypass grafting with the use of minimal invasive extracorporeal circulation

Procedure

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.

Coronary artery bypass grafting under conventional extracorporeal circulation

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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. 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.

Sponsors and collaborators

Lead sponsor

AHEPA University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2020
Study completion
2020
First posted
May 22, 2012
Registry last updated
Jan 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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