Cardiac Surgery Requiring Cardiopulmonary Bypass, Extracorporeal Circulation
Conditions
Keywords
Bio-compatible, Surface Coating, Thromboresistance, Coagulation, cardiopulmonary bypass, extracorporeal circulation, cardiac surgery
Brief 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. 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.
Interventions
PROCEDURECardiac surgery with the use of extracorporeal circulation
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.
Sponsors
Polychronis Antonitsis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Planned surgery
Exclusion criteria
* Need for emergency surgery * Serious hematological condition causing anemia, thrombocytopenia, etc. * Receiving immunosuppressive treatment * Inability to obtain consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prothrombin fragments 1+2 (F1+2) | 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) | 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 | 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 | Immediately after the cessation of cardiopulmonary bypass. | Quantitative evaluation of microthrombi on the walls of the circuit tubes as detected by electron microscopy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICU stay | From the day of surgery until the day of discharge from hospital, assessed up to one month. | ICU stay in hours. |
| Mortality | From the day of surgery up to 30 postoperative days | Death from any cause |
| Hospital stay | From the day of surgery until the day of discharge from hospital, assessed up to one month. | Total hospital stay in days |
| Transfusion | 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 |
| Major morbidity | 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). |
| Bleeding | 12 hours after surgery | Volume of blood collected at the chest tubes. |
Countries
Greece
Outcome results
None listed