Minimal Extracorporeal Circuits (MECC) in Cardiac Surgery... | NCT01306903

Studies
Minimal Extracorporeal Circuits (MECC) in Cardiac Surgery Procedures

NCT01306903

Sponsor

Johann Wolfgang Goethe University Hospital

Status

Completed

Last Update Posted

Jun 4, 2013Estimated

Enrollment

68Actual

Phase

Not Applicable

Conditions

Postoperative Bloodloss

Interventions

MECC
MOPS
Super MOPS

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

Jun 2013Actual

Completion Date

Jun 2013Actual

First Submitted Date

Mar 1, 2011

First Submission Date that Met QC Criteria

Mar 1, 2011

First Posted Date

Mar 2, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 3, 2013

Last Update Posted Date

Jun 4, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Arndt-H. Kiessling, PI, Johann Wolfgang Goethe University HospitalPrincipal Investigator

Lead Sponsor

Johann Wolfgang Goethe University HospitalOTHER

Collaborators

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

68Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MECC	Experimental	Minimal extracorporeal circuit	Device: MECC
MOPS	Placebo Comparator		Device: MOPS
Super MOPS	Placebo Comparator		Device: Super MOPS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MECC	Device	Minimized extracorporeal circulation	MECC
MOPS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bloodloss	Count of red blood packages	postoperative

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

extracorporeal circulation
age > 18 years old

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Arndt H Kiessling, MD	Goethe University Frankfurt	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Goethe University Hospital		Frankfurt		60590	Germany

Label	URL
Research THG	View source

Intervention Browse Module

MeSH Terms

ID	Term
D020374	Chromatography, Micellar Electrokinetic Capillary

Ancestor Terms

ID	Term
D002845	Chromatography
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided