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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
50
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.
Interbalkan Hospital
Thessaloniki, Thessaloniki, Greece
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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Immediately after the cessation of cardiopulmonary bypass.
Mortality
Death from any cause
Time frame: From the day of surgery up to 30 postoperative days
Transfusion
Incidence of blood product (RBC, FFP, platelet) transfusion
Time frame: 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).
Time frame: 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.
Time frame: 12 hours after surgery
ICU stay
ICU stay in hours.
Time frame: From the day of surgery until the day of discharge from hospital, assessed up to one month.
Hospital stay
Total hospital stay in days
Time frame: From the day of surgery until the day of discharge from hospital, assessed up to one month.
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