Inflammation Clinical Trial
— RheoMECCOfficial title:
Coagulation, Inflammation and Cerebral Embolism Using a Rheoparin-coated Tubing System for Minimized Extracorporeal Circulation (MECC): Differences to the Conventional MECC System
NCT number | NCT02321917 |
Other study ID # | 143/13 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2013 |
Est. completion date | December 2019 |
Verified date | December 2019 |
Source | University Hospital Inselspital, Berne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | December 2019 |
Est. primary completion date | November 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
Switzerland | Dep. Cardiovascular Surgery | Bern | |
Switzerland | Inselspital, University Hospital Bern, University of Bern | Bern |
Lead Sponsor | Collaborator |
---|---|
University Hospital Inselspital, Berne |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Perioperative period, 7 days | |
Secondary | Cerebral embolism | Perioperative period, 7 days | ||
Secondary | Mortality | At 30 days |
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