Rheoparin-coated Tubing System for Minimized Extracorporeal Circulation (MECC) (RheoMECC)
Primary Purpose
Extracorporeal Circulation, Inflammation, Blood Coagulation
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
MECC system with rheoparin coating
Sponsored by
About this trial
This is an interventional treatment trial for Extracorporeal Circulation
Eligibility Criteria
Inclusion Criteria:
- Written informed consent
- Elective cardiac surgery
- Coronary artery bypass grafting
Exclusion Criteria
- Re do
- Usage of antiplatelets, antithrombotic drugs
- Coagulopathy
- Persistent foramen ovale
- Infection
- Heparin-induced thrombocytopenia (HIT)
Sites / Locations
- Dep. Cardiovascular Surgery
- Inselspital, University Hospital Bern, University of Bern
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Rheoparin coating
No rheoparin coating
Arm Description
MECC system with rheoparin coating
MECC system without rheoparin coating
Outcomes
Primary Outcome Measures
Change from baseline in coagulation / inflammation parameters at the post-operative phase
Biocompatibility will be assessed by measuring different coagulatory and inflammatory parameters as determined in comparable studies. Especially, hte investigators assess in their central laboratory the thrombin-antithrombin complex and the d-dimer as measures of the activity of the coagulation/fibrinolysis system and furthermore the complement factors C3a-C5a, the interleukins IL 6, IL8, IL10, the tumor-necrosis factor alpha (TNF-alpha), platelet factor 4 and the syndecan-1 activity as an expression of the inflammatory response to the different coating used for minimized extracorporeal circulation system.
Secondary Outcome Measures
Cerebral embolism
Mortality
Full Information
NCT ID
NCT02321917
First Posted
December 11, 2014
Last Updated
December 18, 2019
Sponsor
Insel Gruppe AG, University Hospital Bern
1. Study Identification
Unique Protocol Identification Number
NCT02321917
Brief Title
Rheoparin-coated Tubing System for Minimized Extracorporeal Circulation (MECC)
Acronym
RheoMECC
Official Title
Coagulation, Inflammation and Cerebral Embolism Using a Rheoparin-coated Tubing System for Minimized Extracorporeal Circulation (MECC): Differences to the Conventional MECC System
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
April 2013 (Actual)
Primary Completion Date
November 2019 (Actual)
Study Completion Date
December 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In this study, the investigators would like to compare a heparin-coated tubing system for minimized extracorporeal circulation (MECC) with the conventional tubing system for MECC, which does not contain heparin coating. The MECC system has been used since 14 years in the investigators' hospital as an extracorporeal system to support circulation and provide oxygen to the tissues during coronary artery bypass grafting. Until today, the investigators performed more than 5000 MECC procedures in their department.
Detailed Description
Background
The investigators would like to investigate a new composition of their MECC system in patients receiving coronary artery bypass surgery. Normally, the MECC system induces complement system activation and coagulation cascade, which could have a negative impact on postoperative outcome. A tubing system containing heparin (rheoparin) could contribute to a better biocompatibility in terms of a diminished activation of inflammatory reactions and a reduction of cerebral embolic load, which is a regular issue during extracorporeal circulation due to formation of solid and gaseous microemboli in the tubing system.
Objective
The aim is to investigate biocompatibility (coagulation, inflammation) and influence on cerebral embolic load of the rheoparin-coated MECC system and to compare the results with the current MECC system containing a rheoparin-free tubing system.
Methods
Patients undergoing elective coronary artery surgery are randomized to receive extracorporeal circulation using the MECC system with or without rheoparin coating. All procedures are performed according to the institutional standards.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extracorporeal Circulation, Inflammation, Blood Coagulation, Intracranial Embolism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rheoparin coating
Arm Type
Active Comparator
Arm Description
MECC system with rheoparin coating
Arm Title
No rheoparin coating
Arm Type
No Intervention
Arm Description
MECC system without rheoparin coating
Intervention Type
Device
Intervention Name(s)
MECC system with rheoparin coating
Intervention Description
MECC system for extracorporeal circulation equipped with rheoparin coating.
Primary Outcome Measure Information:
Title
Change from baseline in coagulation / inflammation parameters at the post-operative phase
Description
Biocompatibility will be assessed by measuring different coagulatory and inflammatory parameters as determined in comparable studies. Especially, hte investigators assess in their central laboratory the thrombin-antithrombin complex and the d-dimer as measures of the activity of the coagulation/fibrinolysis system and furthermore the complement factors C3a-C5a, the interleukins IL 6, IL8, IL10, the tumor-necrosis factor alpha (TNF-alpha), platelet factor 4 and the syndecan-1 activity as an expression of the inflammatory response to the different coating used for minimized extracorporeal circulation system.
Time Frame
Perioperative period, 7 days
Secondary Outcome Measure Information:
Title
Cerebral embolism
Time Frame
Perioperative period, 7 days
Title
Mortality
Time Frame
At 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Written informed consent
Elective cardiac surgery
Coronary artery bypass grafting
Exclusion Criteria
Re do
Usage of antiplatelets, antithrombotic drugs
Coagulopathy
Persistent foramen ovale
Infection
Heparin-induced thrombocytopenia (HIT)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry Carrel, MD, PhD
Organizational Affiliation
Dep. Cardiovascular Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dep. Cardiovascular Surgery
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Inselspital, University Hospital Bern, University of Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
12. IPD Sharing Statement
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Rheoparin-coated Tubing System for Minimized Extracorporeal Circulation (MECC)
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