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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02321917
Other study ID # 143/13
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2013
Est. completion date December 2019

Study information

Verified date December 2019
Source University Hospital Inselspital, Berne
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date December 2019
Est. primary completion date November 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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)

Study Design


Intervention

Device:
MECC system with rheoparin coating
MECC system for extracorporeal circulation equipped with rheoparin coating.

Locations

Country Name City State
Switzerland Dep. Cardiovascular Surgery Bern
Switzerland Inselspital, University Hospital Bern, University of Bern Bern

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Cerebral embolism Perioperative period, 7 days
Secondary Mortality At 30 days
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