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Neurocognitive Outcome After Coronary Artery Bypass Surgery Using Minimal Versus Conventional Extracorporeal Circulation

NCT01213511 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2013-11-28

No results posted yet for this study

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.

Conditions

  • Coronary Artery Bypass

Interventions

PROCEDURE

Coronary artery bypass grafting with the use of minimal extracorporeal circulation

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).

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.

Sponsors & Collaborators

  • AHEPA University Hospital

    lead OTHER

Principal Investigators

  • Kyriakos Anastasiadis, FETCS · Department of Cardiothoracic Surgery, AHEPA University Hospital, Thessaloniki, Greece

  • Christos Papakonstantinou, Professor · Department of Cardiothoracic Surgery, AHEPA University Hospital, Thessaloniki, Greece

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2011-01-31
Completion
2012-06-30

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01213511 on ClinicalTrials.gov