Clinical trial NCT02321917: Rheoparin-coated Tubing System for Minimized Extracorporeal Circulation (MECC)
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
Overall status: COMPLETED
Phase: NA
Conditions: Extracorporeal Circulation
Inflammation
Blood Coagulation
Intracranial Embolism
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2014-12-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change from baseline in coagulation / inflammation parameters at the post-operative phase
timeFrame: Perioperative period, 7 days
Secondary outcomes:
measure: Cerebral embolism
timeFrame: Perioperative period, 7 days
measure: Mortality
timeFrame: At 30 days
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Dep. Cardiovascular Surgery
city: Bern
country: Switzerland
facility: Inselspital, University Hospital Bern, University of Bern
Study officials:
affiliation: Dep. Cardiovascular Surgery
name: Thierry Carrel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: