Comparison of Minimal Versus Conventional Extracorporeal Circulation in Coronary Surgery

AHEPA University Hospital

Status: Completed

Conditions: Coronary Artery Bypass

Treatments: Procedure: Coronary artery bypass grafting with the use of minimal invasive extracorporeal circulation; Procedure: Coronary artery bypass grafting under conventional extracorporeal circulation

Study type: Interventional

Funder types: Other

Identifiers

NCT01603589

AHEPA_CTS_04

Details and patient eligibility

About

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).

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups

MiECC group

Active Comparator group

Description:

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

Treatment:

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

CECC group

Active Comparator group

Description:

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

Treatment:

Procedure: Coronary artery bypass grafting under conventional extracorporeal circulation