Extracorporeal CirculationRheoMECCNCT02321917
Rheoparin-coated Tubing System for Minimized Extracorporeal Circulation (MECC)
A study testing MECC system with rheoparin coating in people with Extracorporeal Circulation and Inflammation, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Extracorporeal Circulation, Inflammation, Blood Coagulation
- What is being tested?
- MECC system with rheoparin coating
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Apr 2013to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Elective cardiac surgery
- Coronary artery bypass grafting
Who cannot join
- Re do
- Usage of antiplatelets, antithrombotic drugs
- Coagulopathy
- Persistent foramen ovale
- Infection
- Heparin-induced thrombocytopenia (HIT)
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Dep. Cardiovascular Surgery
Bern, 3010
Inselspital, University Hospital Bern, University of Bern
Bern, 3010
About this study
Official title: Coagulation, Inflammation and Cerebral Embolism Using a Rheoparin-coated Tubing System for Minimized Extracorporeal Circulation (MECC): Differences to the Conventional MECC System
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.
Read the 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.
- Being tested
- MECC system with rheoparin coating
- Medical subject headings
- Inflammation, Thrombosis, Intracranial Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MECC system with rheoparin coatingDevice
MECC system for extracorporeal circulation equipped with rheoparin coating.
| Study group | Role | What they receive |
|---|---|---|
| Rheoparin coating | Active comparator | MECC system with rheoparin coating Receives: Device: MECC system with rheoparin coating |
| No rheoparin coating | No intervention | MECC system without rheoparin coating |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Perioperative period, 7 days
Secondary outcomes (2)
Cerebral embolism
Measured: Perioperative period, 7 days
Mortality
Measured: At 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2014 (estimated)
- Study startApr 2013
- Primary completionNov 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Extracorporeal CirculationStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry Carrel, MD, PhD, Principal investigator, Dep. Cardiovascular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02321917
- Sponsor's protocol ID
- 143/13
- Acronym
- RheoMECC
- Status last verified
- Dec 2019
- First submitted
- 11 Dec 2014
- Last updated
- 19 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jenni H, Kovacic B, Mihalj M, Huber M, Rieben R, Carrel T, Siepe M, Kadner A, Erdoes G. Comparable bleeding and inflammation outcomes between heparin-coated and uncoated minimal invasive extracorporeal circuits in isolated coronary artery bypass surgery - A double-blinded randomized control trial. Perfusion. 2025 Jul;40(5):1248-1257. doi: 10.1177/02676591241290924. Epub 2024 Oct 7.
PubMed 39373400
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coagulation, Inflammation and Cerebral Embolism Using a Rheoparin-coated Tubing System for Minimized Extracorporeal Circulation (MECC): Differences to the Conventional MECC System
- ClinicalTrials.gov ID
- NCT02321917
- Acronym / sponsor ID
- RheoMECC / 143/13
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Apr 2013 (actual)
- Primary completion
- Nov 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 22 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rheoparin coating | Active comparator | Device: MECC system with rheoparin coatingMECC system with rheoparin coating |
| No rheoparin coating | No intervention | –MECC system without rheoparin coating |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent
- Elective cardiac surgery
- Coronary artery bypass grafting
Key exclusion criteria (6 listed)
- Re do
- Usage of antiplatelets, antithrombotic drugs
- Coagulopathy
- Persistent foramen ovale
- Infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MECC system with rheoparin coatingMECC system for extracorporeal circulation equipped with rheoparin coating. | Device | Rheoparin coating |
Primary outcome
Change from baseline in coagulation / inflammation parameters at the post-operative phase
Time frame: Perioperative period, 7 days
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.
2 secondary outcomes
Cerebral embolism
Time frame: Perioperative period, 7 days
Mortality
Time frame: At 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2019.
- Derived from this study: PubMed 39373400Jenni H, Kovacic B, Mihalj M, Huber M, Rieben R, Carrel T, Siepe M, Kadner A, Erdoes G. Comparable bleeding and inflammation outcomes between heparin-coated and uncoated minimal invasive extracorporeal circuits in isolated coronary artery bypass surgery - A double-blinded randomized control trial. Perfusion. 2025 Jul;40(5):1248-1257. doi: 10.1177/02676591241290924. Epub 2024 Oct 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thierry Carrel, MD, PhD principal investigator
Dep. Cardiovascular Surgery
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MECC system with rheoparin coating in people with Extracorporeal Circulation and Inflammation, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in coagulation / inflammation parameters at the post-operative phase (time frame: Perioperative period, 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02321917, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2019.