Clinical trial NCT06612060: Biocompatible Versus Non-coated Extracorporeal Circuits in Cardiac Surgery
Official title: Comparative Randomized Study of Blood Coagulation Triggering and Thromboresistance of Biocompatible Versus Non-coated Extracorporeal Circuits During Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Surgery Requiring Cardiopulmonary Bypass
Extracorporeal Circulation
Keywords: Bio-compatible
Surface Coating
Thromboresistance
Coagulation
cardiopulmonary bypass
extracorporeal circulation
cardiac surgery
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2024-09-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Prothrombin fragments 1+2 (F1+2)
timeFrame: Change from baseline at 40 and 80 minutess after initiation of extracorporeal circulation
measure: Thrombin/Antithrombin complex (TAT)
timeFrame: Change from baseline at 40 and 80 minutess after initiation of extracorporeal circulation
measure: Platelet factor P-selectin
timeFrame: Change from baseline at 40 and 80 minutes after initiation of extracorporeal circulation
measure: Circuit microthrombi
timeFrame: Immediately after the cessation of cardiopulmonary bypass.
Secondary outcomes:
measure: Mortality
timeFrame: From the day of surgery up to 30 postoperative days
measure: Transfusion
timeFrame: From the day of surgery until the day of discharge from hospital, assessed up to one month.
measure: Major morbidity
timeFrame: From the day of surgery until the day of discharge from hospital, assessed up to one month.
measure: Bleeding
timeFrame: 12 hours after surgery
measure: ICU stay
timeFrame: From the day of surgery until the day of discharge from hospital, assessed up to one month.
measure: Hospital stay
timeFrame: From the day of surgery until the day of discharge from hospital, assessed up to one month.
Other outcomes:
Locations:
city: Thessaloníki
country: Greece
facility: Interbalkan Hospital
state: Thessaloniki
Study officials:
affiliation: Aristotle University Of Thessaloniki
name: Isaak Keremidis, MScP
role: PRINCIPAL_INVESTIGATOR
affiliation: Aristotle University of Theesaloniki School of Medicine
name: Polychronis Antonitsis, MD, PhD
role: STUDY_CHAIR
affiliation: Aristole University of Thessaloniki School of Medicine
name: Kali Makedou, MD, PhD
role: STUDY_DIRECTOR
affiliation: Aristotle University Of Thessaloniki
name: Theodora Papamitsou, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Gore S, Andersson J, Biran R, Underwood C, Riesenfeld J. Heparin surfaces: Impact of immobilization chemistry on hemocompatibility and protein adsorption. J Biomed Mater Res B Appl Biomater. 2014 Nov;102(8):1817-24. doi: 10.1002/jbm.b.33154. Epub 2014 Apr 8.
citation: Modrau IS, Halle DR, Nielsen PH, Kimose HH, Greisen JR, Kremke M, Hvas AM. Impact of minimally invasive extracorporeal circulation on coagulation-a randomized trial. Eur J Cardiothorac Surg. 2020 Jun 1;57(6):1145-1153. doi: 10.1093/ejcts/ezaa010.
citation: Teligui L, Dalmayrac E, Mabilleau G, Macchi L, Godon A, Corbeau JJ, Denomme AS, Bouquet E, Boer C, Baufreton C. An ex vivo evaluation of blood coagulation and thromboresistance of two extracorporeal circuit coatings with reduced and full heparin dose. Interact Cardiovasc Thorac Surg. 2014 Jun;18(6):763-9. doi: 10.1093/icvts/ivu011. Epub 2014 Mar 14.