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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coated circuit | Experimental | Cardiac surgery with a specialized biocompatible extracorporeal circulation circuit with a hydrophobic coating. |
|
| Non-coated circuit | Active Comparator | Cardiac surgery with the conventional non-coated extracorporeal circulation circuit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac surgery with the use of extracorporeal circulation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 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. | Immediately after the cessation of cardiopulmonary bypass. |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Death from any cause | From the day of surgery up to 30 postoperative days |
| Transfusion | Incidence of blood product (RBC, FFP, platelet) transfusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Isaak Keremidis, MScP | Aristotle University Of Thessaloniki | Principal Investigator |
| Polychronis Antonitsis, MD, PhD | Aristotle University of Theesaloniki School of Medicine | Study Chair |
| Kali Makedou, MD, PhD | Aristole University of Thessaloniki School of Medicine | Study Director |
| Theodora Papamitsou, MD, PhD | Aristotle University Of Thessaloniki | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Interbalkan Hospital | Thessaloniki | Thessaloniki | 55535 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24711209 | Background | 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. | |
| 32011717 | Background | 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. |
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| ID | Term |
|---|---|
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D006348 | Cardiac Surgical Procedures |
| ID | Term |
|---|---|
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019616 | Thoracic Surgical Procedures |
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| 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). | 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. | 12 hours after surgery |
| ICU stay | ICU stay in hours. | From the day of surgery until the day of discharge from hospital, assessed up to one month. |
| Hospital stay | Total hospital stay in days | From the day of surgery until the day of discharge from hospital, assessed up to one month. |
| 24632424 | Background | 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. |