MedTrace Logo

Biocompatible Versus Non-coated Extracorporeal Circuits in Cardiac Surgery

NCT06612060 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-05-28

No results posted yet for this study

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

Interventions

PROCEDURE

Cardiac 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 & Collaborators

  • Polychronis Antonitsis

    lead OTHER

Principal Investigators

  • Isaak Keremidis, MScP · Aristotle University Of Thessaloniki

  • Polychronis Antonitsis, MD, PhD · Aristotle University of Theesaloniki School of Medicine

  • Kali Makedou, MD, PhD · Aristole University of Thessaloniki School of Medicine

  • Theodora Papamitsou, MD, PhD · Aristotle University Of Thessaloniki

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Greece

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06612060 on ClinicalTrials.gov