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Rheoparin-coated Tubing System for Minimized Extracorporeal Circulation (MECC)

NCT ID: NCT02321917

Last Updated: 2019-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Extracorporeal Circulation Inflammation Blood Coagulation Intracranial Embolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Rheoparin coating

MECC system with rheoparin coating

Group Type ACTIVE_COMPARATOR

MECC system with rheoparin coating

Intervention Type DEVICE

MECC system for extracorporeal circulation equipped with rheoparin coating.

No rheoparin coating

MECC system without rheoparin coating

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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MECC system with rheoparin coating

MECC system for extracorporeal circulation equipped with rheoparin coating.

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thierry Carrel, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dep. Cardiovascular Surgery

Locations

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Dep. Cardiovascular Surgery

Bern, , Switzerland

Site Status

Inselspital, University Hospital Bern, University of Bern

Bern, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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143/13

Identifier Type: -

Identifier Source: org_study_id