Biocompatible Versus Non-coated Extracorporeal Circuits in Cardiac Surgery

Not Applicable

Completed

• Conditions: Cardiac Surgery Requiring Cardiopulmonary Bypass; Extracorporeal Circulation
• Interventions: Procedure: Cardiac surgery with the use of extracorporeal circulation

• Registration Number: NCT06612060
• Lead Sponsor: Polychronis Antonitsis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-01
• Study First Submitted: 2024-09-09
• Study First Submitted QC: 2024-09-21
• Study First Posted: 2024-09-25
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-25
• Last Update Posted: 2025-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Planned surgery

Exclusion Criteria

• Need for emergency surgery
• Serious hematological condition causing anemia, thrombocytopenia, etc.
• Receiving immunosuppressive treatment
• Inability to obtain consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Coated circuit	Cardiac surgery with the use of extracorporeal circulation	Cardiac surgery with a specialized biocompatible extracorporeal circulation circuit with a hydrophobic coating.
Non-coated circuit	Cardiac surgery with the use of extracorporeal circulation	Cardiac surgery with the conventional non-coated extracorporeal circulation circuit.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Mortality	From the day of surgery up to 30 postoperative days	Death from any cause
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.
ICU stay	From the day of surgery until the day of discharge from hospital, assessed up to one month.	ICU stay in hours.
Hospital stay	From the day of surgery until the day of discharge from hospital, assessed up to one month.	Total hospital stay in days

Trial Locations

Locations (1)

Interbalkan Hospital; 🇬🇷 Thessaloníki, Thessaloniki, Greece