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

NCT02321917 | Completed DMC

• 1 other identifier: 143/13
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Extracorporeal Circulation; Inflammation; Blood Coagulation; Intracranial Embolism

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Cerebral embolism

  Perioperative period, 7 days

• Mortality

  At 30 days

Study Arms (2)

Rheoparin coating

ACTIVE COMPARATOR

MECC system with rheoparin coating

Device: MECC system with rheoparin coating

No rheoparin coating

NO INTERVENTION

MECC system without rheoparin coating

Interventions

MECC system with rheoparin coating DEVICE

MECC system for extracorporeal circulation equipped with rheoparin coating.

Rheoparin coating

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• Elective cardiac surgery
• Coronary artery bypass grafting

You may not qualify if:

• Re do
• Usage of antiplatelets, antithrombotic drugs
• Coagulopathy
• Persistent foramen ovale
• Infection
• Heparin-induced thrombocytopenia (HIT)

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (2)

Dep. Cardiovascular Surgery

Bern, 3010, Switzerland

Location

Inselspital, University Hospital Bern, University of Bern

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Inflammation; Thrombosis; Intracranial Embolism

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Intracranial Embolism and Thrombosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Thromboembolism

Study Officials

• Thierry Carrel, MD, PhD

  Dep. Cardiovascular Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2014
• First Posted: December 22, 2014
• Study Start: April 1, 2013
• Primary Completion: November 1, 2019
• Study Completion: December 1, 2019
• Last Updated: December 19, 2019

Record last verified: 2019-12

Locations

CH (2)