Biocompatible Versus Non-coated Extracorporeal Circuits in Cardiac Surgery

NCT06612060 | Completed

• 1 other identifier: BALANCE_CTS
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Surgery Requiring Cardiopulmonary Bypass; Extracorporeal Circulation

Keywords

Bio-compatible; Surface Coating; Thromboresistance; Coagulation; cardiopulmonary bypass; extracorporeal circulation; cardiac surgery

Outcome Measures

Primary Outcomes (4)

• Prothrombin fragments 1+2 (F1+2)

  Plasma levels of prothrombin fragments 1+2 (F1+2) (pg/ml) will be calculated at predetermined times using the ELISA technique

  Change from baseline at 40 and 80 minutess after initiation of extracorporeal circulation

• Thrombin/Antithrombin complex (TAT)

  Plasma levels of thrombin/antithrombin complex (TAT) (pg/ml) will be calculated at predetermined times using the ELISA technique

  Change from baseline at 40 and 80 minutess after initiation of extracorporeal circulation

• Platelet factor P-selectin

  Plasma levels of platelet factor P-selectin (pg/ml) will be calculated at predetermined times using the ELISA technique

  Change from baseline at 40 and 80 minutes after initiation of extracorporeal circulation

• Circuit microthrombi

  Quantitative evaluation of microthrombi on the walls of the circuit tubes as detected by electron microscopy.

  Immediately after the cessation of cardiopulmonary bypass.

Secondary Outcomes (6)

• 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.

• Bleeding

  12 hours after surgery

• ICU stay

  From the day of surgery until the day of discharge from hospital, assessed up to one month.

Study Arms (2)

Coated circuit

EXPERIMENTAL

Cardiac surgery with a specialized biocompatible extracorporeal circulation circuit with a hydrophobic coating.

Procedure: Cardiac surgery with the use of extracorporeal circulation

Non-coated circuit

ACTIVE COMPARATOR

Cardiac surgery with the conventional non-coated extracorporeal circulation circuit.

Procedure: Cardiac surgery with the use of extracorporeal circulation

Interventions

Cardiac surgery with the use of extracorporeal circulation PROCEDURE

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.

Coated circuit; Non-coated circuit

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Planned surgery

You may not qualify if:

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

Sponsors & Collaborators

• Polychronis Antonitsis: lead

Study Sites (1)

Interbalkan Hospital

Thessaloniki, Thessaloniki, 55535, Greece

Location

Related Publications (3)

• 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.

  PMID: 24711209 BACKGROUND

• 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.

  PMID: 32011717 BACKGROUND

• 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.

  PMID: 24632424 BACKGROUND

MeSH Terms

Conditions

Thrombosis

Interventions

Cardiac Surgical Procedures

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• Isaak Keremidis, MScP

  Aristotle University Of Thessaloniki

  PRINCIPAL INVESTIGATOR

• Polychronis Antonitsis, MD, PhD

  Aristotle University of Theesaloniki School of Medicine

  STUDY CHAIR

• Kali Makedou, MD, PhD

  Aristole University of Thessaloniki School of Medicine

  STUDY DIRECTOR

• Theodora Papamitsou, MD, PhD

  Aristotle University Of Thessaloniki

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Cardiac Surgery

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 25, 2024
• Study Start: April 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)