Comparative Randomized Study of Blood Coagulation Triggering and Thromboresistance of Biocompatible Versus Non-coated Extracorporeal Circuits During Cardiac Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiac Surgery Requiring Cardiopulmonary Bypass
- Sponsor
- Polychronis Antonitsis
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Prothrombin fragments 1+2 (F1+2)
- Status
- Completed
- Last Updated
- 11 months ago
Overview
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.
Investigators
Polychronis Antonitsis
Associate Professor of Cardiac Surgery
Aristotle University Of Thessaloniki
Eligibility Criteria
Inclusion Criteria
- •Planned surgery
Exclusion Criteria
- •Need for emergency surgery
- •Serious hematological condition causing anemia, thrombocytopenia, etc.
- •Receiving immunosuppressive treatment
- •Inability to obtain consent
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- ICU stay(From the day of surgery until the day of discharge from hospital, assessed up to one month.)
- Bleeding(12 hours after surgery)
- Mortality(From the day of surgery up to 30 postoperative days)
- Transfusion(From the day of surgery until the day of discharge from hospital, assessed up to one month.)
- Major morbidity(From the day of surgery until the day of discharge from hospital, assessed up to one month.)
- Hospital stay(From the day of surgery until the day of discharge from hospital, assessed up to one month.)