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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Arndt-H. Kiessling, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT01306903
First received: March 1, 2011
Last updated: June 3, 2013
Last verified: June 2013
  Purpose

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 Intervention
Postoperative Bloodloss Device: MECC Device: MOPS Device: Super MOPS

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Minimal Extracorporeal Circuits (MECC) in Cardiac Surgery Procedures

Resource links provided by NLM:


Further study details as provided by Arndt-H. Kiessling, Johann Wolfgang Goethe University Hospitals:

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


Enrollment: 68
Study Start Date: March 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

Inclusion Criteria:

  • extracorporeal circulation
  • age > 18 years old
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01306903

Locations
Germany
Goethe University Hospital
Frankfurt, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Investigators
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
Study First Received: March 1, 2011
Last Updated: June 3, 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
Hemorrhage
Pathologic Processes
Postoperative Complications

ClinicalTrials.gov processed this record on August 18, 2017