Biocompatible Versus Non-coated Extracorporeal Circuits in Cardiac Surgery
Launched by POLYCHRONIS ANTONITSIS · Sep 21, 2024
Trial Information
Current as of July 06, 2025
Completed
Keywords
ClinConnect Summary
This clinical trial is looking at two different types of equipment used during heart surgery that requires a heart-lung machine (called extracorporeal circulation). The study wants to find out if using a special biocompatible circuit with a special coating helps reduce blood clotting and the formation of small clots, known as microthrombi, compared to a regular non-coated circuit. In total, 50 patients scheduled for heart surgery will be randomly assigned to one of two groups: one group will use the biocompatible circuit, and the other group will use the conventional circuit. Researchers will take blood samples during the surgery to measure certain markers related to blood clotting and will also examine the circuit tubing for any small clots.
To participate in this study, patients must be scheduled for planned heart surgery and be between the ages of 65 and 74. However, those who need emergency surgery or have serious blood disorders, are taking medications that suppress the immune system, or cannot provide consent will not be eligible. Participants can expect to have their blood tested and the equipment used during their surgery observed closely to help the researchers gather important data on how well the coated circuits work.
Gender
ALL
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
About Polychronis Antonitsis
Polychronis Antonitsis is a dedicated clinical trial sponsor known for its commitment to advancing medical research and improving patient outcomes. With a focus on innovative therapeutic solutions, the organization specializes in designing and managing clinical trials across various therapeutic areas. Leveraging a robust network of clinical sites and collaborations with healthcare professionals, Polychronis Antonitsis ensures rigorous adherence to regulatory standards and ethical practices. The sponsor is dedicated to fostering transparency and collaboration throughout the research process, aiming to contribute significantly to the development of safe and effective treatments for diverse medical conditions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Thessaloníki, Thessaloniki, Greece
Patients applied
Trial Officials
Isaak Keremidis, MScP
Principal Investigator
Aristotle University Of Thessaloniki
Polychronis Antonitsis, MD, PhD
Study Chair
Aristotle University of Theesaloniki School of Medicine
Kali Makedou, MD, PhD
Study Director
Aristole University of Thessaloniki School of Medicine
Theodora Papamitsou, MD, PhD
Study Director
Aristotle University Of Thessaloniki
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported