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Minimal Extracorporeal Circuits (MECC) in Cardiac Surgery Procedures (MECC)

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ClinicalTrials.gov Identifier: NCT01306903
Recruitment Status : Completed
First Posted : March 2, 2011
Last Update Posted : June 4, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:

The standard heart-lung machine is a major trigger of systemic inflammatory reactions, hemodilution, coagulopathy or organ failure. The strict reduction of blood-artificial surface and blood-air contact might represent meaningful improvements of the extracorporeal technology with respect to organ preservation.

The aim of this study is the evaluation of potential differences between a minimal extracorporeal circuit (MECC) and a conventional cardiopulmonary bypass (MOPS) system.

Condition or disease Intervention/treatment
Postoperative Bloodloss Device: MECC Device: MOPS Device: Super MOPS

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Minimal Extracorporeal Circuits (MECC) in Cardiac Surgery Procedures
Study Start Date : March 2011
Primary Completion Date : June 2013
Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: MECC
Minimal extracorporeal circuit
Device: MECC
Minimized extracorporeal circulation
Placebo Comparator: MOPS Device: MOPS
Modified and optimized perfusion system Frankfurt
Placebo Comparator: Super MOPS Device: Super MOPS
Super modified and optimized perfusion system Frankfurt

Outcome Measures

Primary Outcome Measures :
  1. Bloodloss [ Time Frame: postoperative ]
    Count of red blood packages

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • extracorporeal circulation
  • age > 18 years old
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01306903

Goethe University Hospital
Frankfurt, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Principal Investigator: Arndt H Kiessling, MD Cooperative Weichteilsarkom Study Group
More Information

Additional Information:
Responsible Party: Arndt-H. Kiessling, PI, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT01306903     History of Changes
Other Study ID Numbers: Mini-ECC001AHK
First Posted: March 2, 2011    Key Record Dates
Last Update Posted: June 4, 2013
Last Verified: June 2013

Keywords provided by Arndt-H. Kiessling, Johann Wolfgang Goethe University Hospitals:
Minimizing Cardiopulmonary Bypass MECC damage organ failure

Additional relevant MeSH terms:
Postoperative Hemorrhage
Pathologic Processes
Postoperative Complications