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

I

Insel Gruppe AG, University Hospital Bern

Status

Completed

Conditions

Inflammation
Intracranial Embolism
Blood Coagulation
Extracorporeal Circulation

Treatments

Device: MECC system with rheoparin coating

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

50 participants in 2 patient groups

Rheoparin coating
Active Comparator group
Description:
MECC system with rheoparin coating
Treatment:
Device: MECC system with rheoparin coating
No rheoparin coating
No Intervention group
Description:
MECC system without rheoparin coating

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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