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Completed

NCT Number: NCT06612060

Biocompatible Versus Non-coated Extracorporeal Circuits in Cardiac Surgery

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Interbalkan Hospital

Thessaloniki, 55535, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Planned surgery

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Prothrombin fragments 1+2 (F1+2)

    Time frame: 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

  2. Thrombin/Antithrombin complex (TAT)

    Time frame: 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

  3. Platelet factor P-selectin

    Time frame: 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

  4. Circuit microthrombi

    Time frame: Immediately after the cessation of cardiopulmonary bypass.

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

Secondary outcomes

  1. Mortality

    Time frame: From the day of surgery up to 30 postoperative days

    Death from any cause

  2. Transfusion

    Time frame: 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

  3. Major morbidity

    Time frame: 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).

  4. Bleeding

    Time frame: 12 hours after surgery

    Volume of blood collected at the chest tubes.

  5. ICU stay

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

    ICU stay in hours.

  6. Hospital stay

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

    Total hospital stay in days

Sponsors and collaborators

Lead sponsor

Polychronis Antonitsis

Other

Registry information

Official study title

Comparative Randomized Study of Blood Coagulation Triggering and Thromboresistance of Biocompatible Versus Non-coated Extracorporeal Circuits During Cardiac Surgery

Acronym: BALANCE

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 25, 2024
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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