Comparison of Minimal Versus Conventional Extracorporeal Circulation in Coronary Surgery

NCT ID: NCT01603589

Last Updated: 2021-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2020-12-31

Brief Summary

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).

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.

Conditions

Coronary Artery Bypass

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

MiECC group

Patients operated for elective coronary artery bypass grafting with the use of minimal invasive extracorporeal circulation (MiECC).

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

CECC group

Patients operated for elective coronary artery bypass grafting under conventional extracorporeal circulation (CECC).

Group Type: ACTIVE_COMPARATOR

Coronary artery bypass grafting under conventional extracorporeal circulation

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AHEPA University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kyriakos Anastasiadis

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kyriakos Anastasiadis, MD, PhD, FETCS

Role: PRINCIPAL_INVESTIGATOR

Cardiothoracic Department, AHEPA University Hospital, Thessaloniki, Greece

Locations

Cardiothoracic Department, AHEPA University Hospital

Thessaloniki, , Greece

Countries

Greece

References

Anastasiadis K, Antonitsis P, Haidich AB, Argiriadou H, Deliopoulos A, Papakonstantinou C. Use of minimal extracorporeal circulation improves outcome after heart surgery; a systematic review and meta-analysis of randomized controlled trials. Int J Cardiol. 2013 Apr 5;164(2):158-69. doi: 10.1016/j.ijcard.2012.01.020. Epub 2012 Feb 8.

Reference Type: BACKGROUND

PMID: 22325958 (View on PubMed)

Anastasiadis K, Asteriou C, Deliopoulos A, Argiriadou H, Karapanagiotidis G, Antonitsis P, Grosomanidis V, Misias G, Papakonstantinou C. Haematological effects of minimized compared to conventional extracorporeal circulation after coronary revascularization procedures. Perfusion. 2010 Jul;25(4):197-203. doi: 10.1177/0267659110373840. Epub 2010 Jun 1.

Reference Type: BACKGROUND

PMID: 20515982 (View on PubMed)

Related Links

http://www.ctsnet.org

CardioThoracic Surgery Network

Other Identifiers

AHEPA_CTS_04

Identifier Type: -

Identifier Source: org_study_id