Minimal Extracorporeal Circuits (MECC) in Cardiac Surgery Procedures

• Sponsor: Johann Wolfgang Goethe University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01306903
• Collaborator: (none)
• Enrollment: 68
• Location: 1
• Arms: 3
• Duration (Months): 27
• Patients Per Site Per Month: 2.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Bloodloss	Device: MECC; Device: MOPS; Device: Super MOPS	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 68 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Minimal Extracorporeal Circuits (MECC) in Cardiac Surgery Procedures
• Study Start Date: Mar 1, 2011
• Actual Primary Completion Date: Jun 1, 2013
• Actual Study Completion Date: Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Bloodloss [postoperative]

   Count of red blood packages

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• extracorporeal circulation

• age > 18 years old

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Goethe University Hospital	Frankfurt		Germany	60590

Sponsors and Collaborators

• Johann Wolfgang Goethe University Hospital

Investigators

• Principal Investigator: Arndt H Kiessling, MD, Goethe University Frankfurt

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Research THG

Publications

None provided.

• Responsible Party: Arndt-H. Kiessling, PI, Johann Wolfgang Goethe University Hospital
• ClinicalTrials.gov Identifier: NCT01306903
• Other Study ID Numbers: Mini-ECC001AHK
• First Posted: Mar 2, 2011
• Last Update Posted: Jun 4, 2013
• Last Verified: Jun 1, 2013

• Keywords provided by Arndt-H. Kiessling, PI, Johann Wolfgang Goethe University Hospital: Minimizing Cardiopulmonary Bypass MECC damage organ failure
• Additional relevant MeSH terms: Postoperative Hemorrhage

Study Results

No Results Posted as of Jun 4, 2013