Comparison of Minimal Versus Conventional Extracorporeal Circulation in Coronary Surgery
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
1 other identifier
interventional
150
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 21, 2012
CompletedFirst Posted
Study publicly available on registry
May 22, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedJanuary 12, 2021
January 1, 2021
11.9 years
May 21, 2012
January 11, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Remote end-organ perfusion and function (brain, lungs, liver, kidneys, stomach, intestine) intraoperatively and postoperatively during hospital stay
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 Outcomes (6)
Postoperative major adverse cardiac and cerebrovascular events (MACCE) that comprise: myocardial infarction, low cardiac output syndrome, stroke, renal failure.
30 days
Duration of mechanical ventilation
30 days
Length of ICU stay
30 days
Development of new postoperative atrial fibrillation.
30 days
Neurocognitive function
6 months postoperatively
- +1 more secondary outcomes
Study Arms (2)
MiECC group
ACTIVE COMPARATORPatients operated for elective coronary artery bypass grafting with the use of minimal invasive extracorporeal circulation (MiECC).
CECC group
ACTIVE COMPARATORPatients operated for elective coronary artery bypass grafting under conventional extracorporeal circulation (CECC).
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- All patients scheduled for elective coronary artery bypass grafting
You may not qualify if:
- history of psychiatric disorder
- inability to undergo neuropsychological assessment
- history of transient ischemic attack or stroke
- carotid artery stenosis \> 60% assessed by duplex ultrasonography
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cardiothoracic Department, AHEPA University Hospital
Thessaloniki, Greece
Related Publications (2)
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.
PMID: 22325958BACKGROUNDAnastasiadis 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.
PMID: 20515982BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kyriakos Anastasiadis, MD, PhD, FETCS
Cardiothoracic Department, AHEPA University Hospital, Thessaloniki, Greece
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 21, 2012
First Posted
May 22, 2012
Study Start
January 1, 2009
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
January 12, 2021
Record last verified: 2021-01