Minimal Extracorporeal Circuits (MECC) in Cardiac Surgery Procedures

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • Bloodloss [ Time Frame: postoperative ] [ Designated as safety issue: Yes ]
    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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • extracorporeal circulation
  • age > 18 years old
  Contacts and Locations
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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 Hospitals
Investigators
Principal Investigator: Arndt H Kiessling, MD Cooperative Weichteilsarkom Study Group
  More Information

Additional Information:
No publications provided

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
Health Authority: Germany: Ethics Commission

Keywords provided by 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 September 18, 2014