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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01306903
First Posted: March 2, 2011
Last Update Posted: June 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Arndt-H. Kiessling, Johann Wolfgang Goethe University Hospitals
March 1, 2011
March 2, 2011
June 4, 2013
March 2011
June 2013   (Final data collection date for primary outcome measure)
Bloodloss [ Time Frame: postoperative ]
Count of red blood packages
Same as current
Complete list of historical versions of study NCT01306903 on ClinicalTrials.gov Archive Site
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Minimal Extracorporeal Circuits (MECC) in Cardiac Surgery Procedures
Minimal Extracorporeal Circuits (MECC) in Cardiac Surgery Procedures

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.

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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Postoperative Bloodloss
  • Device: MECC
    Minimized extracorporeal circulation
  • Device: MOPS
    Modified and optimized perfusion system Frankfurt
  • Device: Super MOPS
    Super modified and optimized perfusion system Frankfurt
  • Experimental: MECC
    Minimal extracorporeal circuit
    Intervention: Device: MECC
  • Placebo Comparator: MOPS
    Intervention: Device: MOPS
  • Placebo Comparator: Super MOPS
    Intervention: Device: Super MOPS
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
68
June 2013
June 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • extracorporeal circulation
  • age > 18 years old
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01306903
Mini-ECC001AHK
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Arndt-H. Kiessling, Johann Wolfgang Goethe University Hospitals
Johann Wolfgang Goethe University Hospital
Not Provided
Principal Investigator: Arndt H Kiessling, MD Cooperative Weichteilsarkom Study Group
Johann Wolfgang Goethe University Hospital
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP