Interbalkan Hospital
Thessaloniki, 55535, Greece
NCT Number: NCT06612060
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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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Thessaloniki, 55535, Greece
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
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
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
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.
Time frame: From the day of surgery up to 30 postoperative days
Death from any cause
Time frame: From the day of surgery until the day of discharge from hospital, assessed up to one month.
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.
Composite outcome consisting of: stroke, myocardial infarction, need for revascularization, acute renal failure, prolonged > 48 h need for mechanical ventilation, reoperation).
Time frame: 12 hours after surgery
Volume of blood collected at the chest tubes.
Time frame: From the day of surgery until the day of discharge from hospital, assessed up to one month.
ICU stay in hours.
Time frame: From the day of surgery until the day of discharge from hospital, assessed up to one month.
Total hospital stay in days
Polychronis Antonitsis
Other
Comparative Randomized Study of Blood Coagulation Triggering and Thromboresistance of Biocompatible Versus Non-coated Extracorporeal Circuits During Cardiac Surgery
Acronym: BALANCE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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