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NCT01306903 Clinical Trial

Minimal Extracorporeal Circuits (MECC) in Cardiac Surgery Procedures

Postoperative Bloodloss Clinical Trial

— MECC  

Official title:
Minimal Extracorporeal Circuits (MECC) in Cardiac Surgery Procedures

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01306903
Other study ID # Mini-ECC001AHK
Secondary ID
Status Completed
Phase N/A
First received March 1, 2011
Last updated June 3, 2013
Start date March 2011
Est. completion date June 2013

Study information
Verified date June 2013
Source Johann Wolfgang Goethe University Hospitals
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 68
Est. completion date June 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- extracorporeal circulation

- age > 18 years old

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• MECC
Minimized extracorporeal circulation
• MOPS
Modified and optimized perfusion system Frankfurt
• Super MOPS
Super modified and optimized perfusion system Frankfurt

Locations
Country Name City State
Germany Goethe University Hospital Frankfurt

Sponsors (1)
Lead Sponsor Collaborator
Johann Wolfgang Goethe University Hospitals

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Bloodloss Count of red blood packages postoperative Yes

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