Biocompatible Versus Non-coated Extracorporeal Circuits in Cardiac Surgery (BALANCE)
May 25, 2025 updated by: Polychronis Antonitsis
Comparative Randomized Study of Blood Coagulation Triggering and Thromboresistance of Biocompatible Versus Non-coated Extracorporeal Circuits During Cardiac Surgery
The aim of the present strudy is to investigate whether the use of biocompatible extracorporeal circulation circuits with a special hydrophilic polymer coating without heparin causes a reduction in the activation of the coagulation mechanism and the formation of microthrombi in the circuit tubing.
A total of 50 patients undergoing cardiac surgery with extracorporeal circulation will be randomized in two groups using a computer-generated algorithm.
The first group (study group) will undergo cardiac surgery with a specialized biocompatible circuit with a hydrophilic coating, while the control group will be operated with the conventional non-coated extracorporeal circulation circuit.
During the period of extracorporeal circulation, blood samples will be taken at predetermined times which will be analyzed with the ELISA technique to determine the levels of prothrombin fragments 1+2 (F1+2), thrombin/antithrombin complex (TAT) as well as platelet factor P-selectin.
Moreover, sections of the circuit tubes will be examined under electron microscopy for quantitative evaluation of microthrombi detected on the walls.
The expected outcome of the study is to establish, with the use of specific biochemical markers and electron microscopy the protective effect of biocompatible coated extracorporeal circulation circuits on the coagulation mechanism and platelet activation.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Thessaloniki
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Thessaloníki, Thessaloniki, Greece, 55535
- Interbalkan Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Planned surgery
Exclusion Criteria:
- Need for emergency surgery
- Serious hematological condition causing anemia, thrombocytopenia, etc.
- Receiving immunosuppressive treatment
- Inability to obtain consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Coated circuit
Cardiac surgery with a specialized biocompatible extracorporeal circulation circuit with a hydrophobic coating.
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All randomized patients will undergo open heart surgery with the use of extracorporeal circulation.
Criteria for randomization: i) age between 18 and 80 years and ii) elective procedure.
|
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Active Comparator: Non-coated circuit
Cardiac surgery with the conventional non-coated extracorporeal circulation circuit.
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All randomized patients will undergo open heart surgery with the use of extracorporeal circulation.
Criteria for randomization: i) age between 18 and 80 years and ii) elective procedure.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prothrombin fragments 1+2 (F1+2)
Time Frame: Change from baseline at 40 and 80 minutess after initiation of extracorporeal circulation
|
Plasma levels of prothrombin fragments 1+2 (F1+2) (pg/ml) will be calculated at predetermined times using the ELISA technique
|
Change from baseline at 40 and 80 minutess after initiation of extracorporeal circulation
|
|
Thrombin/Antithrombin complex (TAT)
Time Frame: Change from baseline at 40 and 80 minutess after initiation of extracorporeal circulation
|
Plasma levels of thrombin/antithrombin complex (TAT) (pg/ml) will be calculated at predetermined times using the ELISA technique
|
Change from baseline at 40 and 80 minutess after initiation of extracorporeal circulation
|
|
Platelet factor P-selectin
Time Frame: Change from baseline at 40 and 80 minutes after initiation of extracorporeal circulation
|
Plasma levels of platelet factor P-selectin (pg/ml) will be calculated at predetermined times using the ELISA technique
|
Change from baseline at 40 and 80 minutes after initiation of extracorporeal circulation
|
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Circuit microthrombi
Time Frame: Immediately after the cessation of cardiopulmonary bypass.
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Quantitative evaluation of microthrombi on the walls of the circuit tubes as detected by electron microscopy.
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Immediately after the cessation of cardiopulmonary bypass.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mortality
Time Frame: From the day of surgery up to 30 postoperative days
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Death from any cause
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From the day of surgery up to 30 postoperative days
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Transfusion
Time Frame: From the day of surgery until the day of discharge from hospital, assessed up to one month.
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Incidence of blood product (RBC, FFP, platelet) transfusion
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From the day of surgery until the day of discharge from hospital, assessed up to one month.
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Major morbidity
Time Frame: From the day of surgery until the day of discharge from hospital, assessed up to one month.
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Composite outcome consisting of: stroke, myocardial infarction, need for revascularization, acute renal failure, prolonged > 48 h need for mechanical ventilation, reoperation).
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From the day of surgery until the day of discharge from hospital, assessed up to one month.
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Bleeding
Time Frame: 12 hours after surgery
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Volume of blood collected at the chest tubes.
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12 hours after surgery
|
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ICU stay
Time Frame: From the day of surgery until the day of discharge from hospital, assessed up to one month.
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ICU stay in hours.
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From the day of surgery until the day of discharge from hospital, assessed up to one month.
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Hospital stay
Time Frame: From the day of surgery until the day of discharge from hospital, assessed up to one month.
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Total hospital stay in days
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From the day of surgery until the day of discharge from hospital, assessed up to one month.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Polychronis Antonitsis, MD, PhD, Aristotle University of Theesaloniki School of Medicine
- Study Director: Kali Makedou, MD, PhD, Aristole University of Thessaloniki School of Medicine
- Principal Investigator: Isaak Keremidis, MScP, Aristotle University Of Thessaloniki
- Study Director: Theodora Papamitsou, MD, PhD, Aristotle University Of Thessaloniki
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Gore S, Andersson J, Biran R, Underwood C, Riesenfeld J. Heparin surfaces: Impact of immobilization chemistry on hemocompatibility and protein adsorption. J Biomed Mater Res B Appl Biomater. 2014 Nov;102(8):1817-24. doi: 10.1002/jbm.b.33154. Epub 2014 Apr 8.
- Modrau IS, Halle DR, Nielsen PH, Kimose HH, Greisen JR, Kremke M, Hvas AM. Impact of minimally invasive extracorporeal circulation on coagulation-a randomized trial. Eur J Cardiothorac Surg. 2020 Jun 1;57(6):1145-1153. doi: 10.1093/ejcts/ezaa010.
- Teligui L, Dalmayrac E, Mabilleau G, Macchi L, Godon A, Corbeau JJ, Denomme AS, Bouquet E, Boer C, Baufreton C. An ex vivo evaluation of blood coagulation and thromboresistance of two extracorporeal circuit coatings with reduced and full heparin dose. Interact Cardiovasc Thorac Surg. 2014 Jun;18(6):763-9. doi: 10.1093/icvts/ivu011. Epub 2014 Mar 14.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2024
Primary Completion (Actual)
December 31, 2024
Study Completion (Actual)
December 31, 2024
Study Registration Dates
First Submitted
September 9, 2024
First Submitted That Met QC Criteria
September 21, 2024
First Posted (Actual)
September 25, 2024
Study Record Updates
Last Update Posted (Actual)
May 28, 2025
Last Update Submitted That Met QC Criteria
May 25, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BALANCE_CTS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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