Cardiac Surgery Requiring Cardiopulmonary BypassBALANCENCT06612060
Biocompatible Versus Non-coated Extracorporeal Circuits in Cardiac Surgery
A study testing Cardiac surgery with the use of extracorporeal circulation in people with Cardiac Surgery Requiring Cardiopulmonary Bypass and Extracorporeal Circulation, run by Polychronis Antonitsis at 1 site in Greece.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Surgery Requiring Cardiopulmonary Bypass, Extracorporeal Circulation
- What is being tested?
- Cardiac surgery with the use of extracorporeal circulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGreece
- Study dates
- 1 Apr 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planned surgery
Who cannot join
- Need for emergency surgery
- Serious hematological condition causing anemia, thrombocytopenia, etc.
- Receiving immunosuppressive treatment
- Inability to obtain consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Cardiac surgery with the use of extracorporeal circulation
- Keywords
- Bio-compatible, Surface Coating, Thromboresistance, Coagulation, cardiopulmonary bypass, extracorporeal circulation, cardiac surgery
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac surgery with the use of extracorporeal circulationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Coated circuit | Experimental | Cardiac surgery with a specialized biocompatible extracorporeal circulation circuit with a hydrophobic coating. Receives: Procedure: Cardiac surgery with the use of extracorporeal circulation |
| Non-coated circuit | Active comparator | Cardiac surgery with the conventional non-coated extracorporeal circulation circuit. Receives: Procedure: Cardiac surgery with the use of extracorporeal circulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prothrombin fragments 1+2 (F1+2)
Plasma levels of prothrombin fragments 1+2 (F1+2) (pg/ml) will be calculated at predetermined times using the ELISA technique
Measured: Change from baseline at 40 and 80 minutess after initiation of extracorporeal circulation
Thrombin/Antithrombin complex (TAT)
Plasma levels of thrombin/antithrombin complex (TAT) (pg/ml) will be calculated at predetermined times using the ELISA technique
Measured: Change from baseline at 40 and 80 minutess after initiation of extracorporeal circulation
Platelet factor P-selectin
Plasma levels of platelet factor P-selectin (pg/ml) will be calculated at predetermined times using the ELISA technique
Measured: Change from baseline at 40 and 80 minutes after initiation of extracorporeal circulation
Circuit microthrombi
Quantitative evaluation of microthrombi on the walls of the circuit tubes as detected by electron microscopy.
Measured: Immediately after the cessation of cardiopulmonary bypass.
Secondary outcomes (6)
Mortality
Death from any cause
Measured: From the day of surgery up to 30 postoperative days
Transfusion
Incidence of blood product (RBC, FFP, platelet) transfusion
Measured: From the day of surgery until the day of discharge from hospital, assessed up to one month.
Major morbidity
Composite outcome consisting of: stroke, myocardial infarction, need for revascularization, acute renal failure, prolonged \> 48 h need for mechanical ventilation, reoperation).
Measured: From the day of surgery until the day of discharge from hospital, assessed up to one month.
Bleeding
Volume of blood collected at the chest tubes.
Measured: 12 hours after surgery
ICU stay
ICU stay in hours.
Measured: From the day of surgery until the day of discharge from hospital, assessed up to one month.
Hospital stay
Total hospital stay in days
Measured: From the day of surgery until the day of discharge from hospital, assessed up to one month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start1 Apr 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiac Surgery Requiring Cardiopulmonary BypassStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polychronis Antonitsis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Polychronis Antonitsis, Aristotle University Of Thessaloniki
- Investigators
- Isaak Keremidis, MScP, Principal investigator, Aristotle University Of ThessalonikiPolychronis Antonitsis, MD, PhD, Study chair, Aristotle University of Theesaloniki School of MedicineKali Makedou, MD, PhD, Study director, Aristole University of Thessaloniki School of MedicineTheodora Papamitsou, MD, PhD, Study director, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06612060
- Sponsor's protocol ID
- BALANCE_CTS
- Acronym
- BALANCE
- Status last verified
- May 2025
- First submitted
- 9 Sep 2024
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 24711209Modrau 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.
PubMed 32011717Teligui 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.
PubMed 24632424
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Randomized Study of Blood Coagulation Triggering and Thromboresistance of Biocompatible Versus Non-coated Extracorporeal Circuits During Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06612060
- Acronym / sponsor ID
- BALANCE / BALANCE_CTS
- Keywords
- Bio-compatible, Surface Coating, Thromboresistance, Coagulation, cardiopulmonary bypass, extracorporeal circulation, cardiac surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Polychronis AntonitsisUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 25 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coated circuit | Experimental | Procedure: Cardiac surgery with the use of extracorporeal circulationCardiac surgery with a specialized biocompatible extracorporeal circulation circuit with a hydrophobic coating. |
| Non-coated circuit | Active comparator | Procedure: Cardiac surgery with the use of extracorporeal circulationCardiac surgery with the conventional non-coated extracorporeal circulation circuit. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Planned surgery
Key exclusion criteria (4 listed)
- Need for emergency surgery
- Serious hematological condition causing anemia, thrombocytopenia, etc.
- Receiving immunosuppressive treatment
- Inability to obtain consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac surgery with the use of extracorporeal circulationAll 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. | Procedure or surgery | Coated circuit, Non-coated circuit |
Primary outcome
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
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
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
Circuit microthrombi
Time frame: Immediately after the cessation of cardiopulmonary bypass.
Quantitative evaluation of microthrombi on the walls of the circuit tubes as detected by electron microscopy.
6 secondary outcomes
Mortality
Time frame: From the day of surgery up to 30 postoperative days
Transfusion
Time frame: From the day of surgery until the day of discharge from hospital, assessed up to one month.
Major morbidity
Time frame: From the day of surgery until the day of discharge from hospital, assessed up to one month.
Bleeding
Time frame: 12 hours after surgery
ICU stay
Time frame: From the day of surgery until the day of discharge from hospital, assessed up to one month.
Hospital stay
Time frame: From the day of surgery until the day of discharge from hospital, assessed up to one month.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Background: PubMed 24711209Gore 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.
- Background: PubMed 32011717Modrau 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.
- Background: PubMed 24632424Teligui 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isaak Keremidis, MScP principal investigator
Aristotle University Of Thessaloniki
Polychronis Antonitsis, MD, PhD study chair
Aristotle University of Theesaloniki School of Medicine
Kali Makedou, MD, PhD study director
Aristole University of Thessaloniki School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac surgery with the use of extracorporeal circulation in people with Cardiac Surgery Requiring Cardiopulmonary Bypass and Extracorporeal Circulation, run by Polychronis Antonitsis at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prothrombin fragments 1+2 (F1+2) (time frame: Change from baseline at 40 and 80 minutess after initiation of extracorporeal circulation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06612060, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.