Biocompatible Versus Non-coated Extracorporeal Circuits in Cardiac Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of Minimal Versus Conventional Extracorporeal Circulation in Coronary Surgery

NCT01603589

Coronary Artery Bypass

COMPLETED NA

Clinical Evaluation of a Modular Extracorporeal Circulation Circuit

NCT02000544

Coronary Artery Disease Aortic Valve Disease Mitral Valve Disease +1 more

COMPLETED NA

Comparative Analysis of the Microcirculation During Cardiac Surgery With Minimal Invasive Versus Conventional Extracorporeal Circulation

NCT05479188

Coronary Artery Disease Aortic Valve Stenosis Mitral Disease

COMPLETED NA

Study of Microcirculation During Extracorporeal Circulation in Cardiac Surgery

NCT04058860

Heart Diseases

COMPLETED NA

Anticoagulation Management in Complex Cardiac Surgery

NCT05944107

Extracorporeal Circulation

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiac Surgery Requiring Cardiopulmonary Bypass Extracorporeal Circulation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Coated circuit

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

Group Type EXPERIMENTAL

Cardiac surgery with the use of extracorporeal circulation

Intervention Type 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.

Non-coated circuit

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

Group Type ACTIVE_COMPARATOR

Cardiac surgery with the use of extracorporeal circulation

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Planned surgery

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No