Neurocognitive Outcome After Coronary Artery Bypass Surgery Using Minimal Versus Conventional Extracorporeal Circulation
1 other identifier
interventional
64
1 country
1
Brief Summary
The aim of this study is to assess the effect of minimal (MECC) versus conventional (CECC) extracorporeal circulation on neurocognitive function after elective coronary bypass grafting (CABG) as well as whether this can be attributed to improved cerebral perfusion intraoperatively.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-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
October 1, 2010
CompletedFirst Posted
Study publicly available on registry
October 4, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedNovember 28, 2013
November 1, 2013
2 years
October 1, 2010
November 27, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Neurocognitive outcome at 3-month follow-up
Neurocognitive outcome at 3-month follow-up after elective coronary artery bypass grafting with the use of minimal (MECC) versus conventional (CECC) extracorporeal circulation.
3 months
Secondary Outcomes (2)
Neurocognitive outcome at discharge
7-30 days
Episodes of intraoperative cerebral desaturation
During the operation
Study Arms (2)
MECC Group
ACTIVE COMPARATORPatients operated for elective coronary artery bypass grafting with the use of minimal extracorporeal circulation.
CECC Group
ACTIVE COMPARATORGroup of patients undergoing elective coronary bypass grafting with the use of conventional extracorporeal circulation.
Interventions
The MECC system (Maquet Cardiopulmonary, Hirlingen, Germany) consists of a pre-connected closed CPB circuit containing a RotaFlow centrifugal pump and a Quadrox D diffusion membrane oxygenator. A flow meter and a bubble sensor are integrated in the drive unit of the centrifugal pump. The system features a tip-to-tip heparin coating (Bioline Coating, Maquet Cardiopulmonary, Hirlingen, Germany). No arterial or venous line filters are included. Initial priming volume of the system is 500 mL, while using retrograde autologous priming (RAP) the circuit could be filled in with autologous blood, thus reducing hemodilution. Since no cardiotomy suction is used, shed blood is collected with a cell-saving device (Haemonetics Corp, Braintree, MA).
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)
Department of Cardiothoracic Surgery, AHEPA University Hospital
Thessaloniki, 542 48, Greece
Related Publications (3)
Murkin JM, Newman SP, Stump DA, Blumenthal JA. Statement of consensus on assessment of neurobehavioral outcomes after cardiac surgery. Ann Thorac Surg. 1995 May;59(5):1289-95. doi: 10.1016/0003-4975(95)00106-u. No abstract available.
PMID: 7733754BACKGROUNDLiebold A, Khosravi A, Westphal B, Skrabal C, Choi YH, Stamm C, Kaminski A, Alms A, Birken T, Zurakowski D, Steinhoff G. Effect of closed minimized cardiopulmonary bypass on cerebral tissue oxygenation and microembolization. J Thorac Cardiovasc Surg. 2006 Feb;131(2):268-76. doi: 10.1016/j.jtcvs.2005.09.023. Epub 2006 Jan 18.
PMID: 16434253BACKGROUNDAnastasiadis K, Argiriadou H, Kosmidis MH, Megari K, Antonitsis P, Thomaidou E, Aretouli E, Papakonstantinou C. Neurocognitive outcome after coronary artery bypass surgery using minimal versus conventional extracorporeal circulation: a randomised controlled pilot study. Heart. 2011 Jul;97(13):1082-8. doi: 10.1136/hrt.2010.218610. Epub 2011 Feb 28.
PMID: 21357641DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kyriakos Anastasiadis, FETCS
Department of Cardiothoracic Surgery, AHEPA University Hospital, Thessaloniki, Greece
- STUDY CHAIR
Christos Papakonstantinou, Professor
Department of Cardiothoracic Surgery, 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
- Head of Cardiothoracic Department
Study Record Dates
First Submitted
October 1, 2010
First Posted
October 4, 2010
Study Start
January 1, 2009
Primary Completion
January 1, 2011
Study Completion
June 1, 2012
Last Updated
November 28, 2013
Record last verified: 2013-11