Skip to main content
OpenTrials
Completed

NCT Number: NCT02321917

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Extracorporeal Circulation Blood Coagulation Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Embolism and Thrombosis Inflammation Intracranial Embolism Intracranial Embolism and Thrombosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Thromboembolism Thrombosis Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dep. Cardiovascular Surgery, Bern, Switzerland

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

MECC system with rheoparin coating

Device

MECC system for extracorporeal circulation equipped with rheoparin coating.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Cerebral embolism

    Time frame: Perioperative period, 7 days

  2. Mortality

    Time frame: At 30 days

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

Coagulation, Inflammation and Cerebral Embolism Using a Rheoparin-coated Tubing System for Minimized Extracorporeal Circulation (MECC): Differences to the Conventional MECC System

Acronym: RheoMECC

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Dec 22, 2014
Registry last updated
Dec 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.