Back to resultsMinimal Extracorporeal Circuits (MECC) in Cardiac Surgery Procedures (MECC)
Primary Purpose
Postoperative Bloodloss
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
MECC
MOPS
Super MOPS
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Bloodloss focused on measuring Minimizing Cardiopulmonary Bypass MECC damage organ failure
Eligibility Criteria
Inclusion Criteria:
- extracorporeal circulation
- age > 18 years old
Sites / Locations
- Goethe University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Placebo Comparator
Arm Label
MECC
MOPS
Super MOPS
Arm Description
Minimal extracorporeal circuit
Outcomes
Primary Outcome Measures
Bloodloss
Count of red blood packages
Secondary Outcome Measures
Full Information
NCT ID
NCT01306903
First Posted
March 1, 2011
Last Updated
June 3, 2013
Sponsor
Johann Wolfgang Goethe University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01306903
Brief Title
Minimal Extracorporeal Circuits (MECC) in Cardiac Surgery Procedures
Acronym
MECC
Official Title
Minimal Extracorporeal Circuits (MECC) in Cardiac Surgery Procedures
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johann Wolfgang Goethe University Hospital
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Bloodloss
Keywords
Minimizing Cardiopulmonary Bypass MECC damage organ failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MECC
Arm Type
Experimental
Arm Description
Minimal extracorporeal circuit
Arm Title
MOPS
Arm Type
Placebo Comparator
Arm Title
Super MOPS
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
MECC
Intervention Description
Minimized extracorporeal circulation
Intervention Type
Device
Intervention Name(s)
MOPS
Intervention Description
Modified and optimized perfusion system Frankfurt
Intervention Type
Device
Intervention Name(s)
Super MOPS
Intervention Description
Super modified and optimized perfusion system Frankfurt
Primary Outcome Measure Information:
Title
Bloodloss
Description
Count of red blood packages
Time Frame
postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
extracorporeal circulation
age > 18 years old
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arndt H Kiessling, MD
Organizational Affiliation
Goethe University Frankfurt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Goethe University Hospital
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://www.kgu.de/index.php?id=3615
Description
Research THG
Learn more about this trial
Minimal Extracorporeal Circuits (MECC) in Cardiac Surgery Procedures
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