Minimal Extracorporeal Circuits (MECC) in Cardiac Surgery Procedures
This study is currently recruiting participants.
Verified June 2012 by Johann Wolfgang Goethe University Hospitals
Sponsor:
Johann Wolfgang Goethe University Hospitals
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 8, 2012
Last verified: June 2012
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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
| Estimated Enrollment: | 180 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | August 2012 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01306903
Contacts
| Contact: Arndt H Kiessling, MD | 0049696301 ext 0 | arndt.kiessling@kgu.de |
Locations
| Germany | |
| Goethe University Hospital | Recruiting |
| Frankfurt, Germany, 60590 | |
| Contact: Arndt H Kiessling, MD 00496301 ext 0 arndt.kiessling@kgu.de | |
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 8, 2012 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by Johann Wolfgang Goethe University Hospitals:
|
Minimizing Cardiopulmonary Bypass MECC damage organ failure |
Additional relevant MeSH terms:
|
Hemorrhage Postoperative Hemorrhage Pathologic Processes Postoperative Complications |
ClinicalTrials.gov processed this record on May 16, 2013