CLEAR Trial: CA330 Cytokine Adsorption Column for Anticoagulant/Antiplatelet Patients in Non-Elective CPB Surgery.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBeijing Anzhen Hospital

About this trial

The goal of this clinical trial is to evaluate whether the CA330 cytokine adsorption column can reduce perioperative severe bleeding adverse events in patients receiving anticoagulant and/or antiplatelet therapy who undergo non-elective cardiac surgery with cardiopulmonary bypass.

The main questions it aims to answer are:

* Does the use of the CA330 cytokine adsorption column lower the incidence of perioperative severe bleeding compared with standard care? * Does the intervention improve short-term clinical outcomes, such as transfusion requirements, reoperation rates for bleeding, or overall postoperative recovery?

If there is a comparison group: Researchers will compare patients treated with the CA330 cytokine adsorption column versus patients receiving standard cardiopulmonary bypass management to see if cytokine adsorption provides additional safety and efficacy benefits.

Participants will:

* Undergo non-elective cardiac surgery requiring cardiopulmonary bypass. * Be randomly assigned to receive either the CA330 cytokine adsorption column integrated into the CPB circuit (intervention arm) or standard CPB management without the device (control arm). * Be monitored for perioperative bleeding outcomes, transfusion needs, reoperation rates, and overall postoperative prognosis.

Eligibility criteria

Qualifiers

Patients scheduled to undergo non-elective cardiovascular surgery requiring cardiopulmonary bypass;

Patients currently receiving one or more of the following medications - indobufen, ticagrelor, warfarin, cilostazol, dabigatran, rivaroxaban, or apixaban - with the last dose administered within the drug washout period.

Disqualifiers

Patients with a history of chronic liver failure, stage 5 chronic kidney disease (CKD5), or requiring regular dialysis;

Patients in special physiological states: pregnancy or puerperium;

Patients with advanced-stage malignancy or scheduled cardiovascular surgery related to tumor management;

Patients with allergic reactions to cytokine adsorption column resin or related components;

Trial design

Treatments tested in this trial

  • CA330 Cytokine Adsorption Column

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Beijing Anzhen Hospital

Lead sponsor

Shanghai Zhongshan Hospital

Collaborator

Wuhan Asia Heart Hospital

Collaborator

Xijing Hospital

Collaborator

West China Hospital

Collaborator

Guangdong Provincial People's Hospital

Collaborator

Second Xiangya Hospital of Central South University

Collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Collaborator

Henan Provincial Chest Hospital

Collaborator

Army Medical University, China

Collaborator

Tongji Hospital

Collaborator

Xiangya Hospital of Central South University

Collaborator

The First Affiliated Hospital of Zhengzhou University

Collaborator

First Affiliated Hospital Xi'an Jiaotong University

Collaborator