Minimal Extracorporeal Circuits (MECC) in Cardiac Surgery Procedures

Johann Wolfgang Goethe University Hospital

Status: Completed

Conditions: Postoperative Bloodloss

Treatments: Device: MECC; Device: Super MOPS; Device: MOPS

Study type: Interventional

Funder types: Other

Identifiers

NCT01306903

Mini-ECC001AHK

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• extracorporeal circulation
• age > 18 years old

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 3 patient groups, including a placebo group

MECC

Experimental group

Description:

Minimal extracorporeal circuit

Treatment:

Device: MECC

MOPS

Placebo Comparator group

Treatment:

Device: MOPS

Super MOPS

Placebo Comparator group

Treatment:

Device: Super MOPS