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.
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.
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;
Parallel
CA330 Cytokine Adsorption Column
DeviceCA330 Cytokine Adsorption Column (Experimental Arm): The CA330 cytokine adsorption column is a novel hemoperfusion device integrated into the cardiopulmonary bypass (CPB) circuit. During CPB, the column removes specific circulating substances, including inflammatory mediators and residual anticoagulant/antiplatelet drugs, via adsorption. Patients in this arm will undergo non-elective cardiac surgery with standard anesthesia, surgery, and perioperative management, with the addition of the CA330 device placed inline during CPB.
incidence of BARC-4 severe bleeding
The primary endpoint is a composite outcome, defined as the occurrence of any one of the following events: 1. Intracranial hemorrhage within 48 hours of the perioperative period(Number); 2. Reoperation after sternotomy closure to control bleeding(Number); 3. Transfusion of ≥5 units (1,000 mL) of whole blood or packed red blood cells within 48 hours(Number); 4. Postoperative chest drainage ≥2 L within 24 hours(Number). Unit of measure: number of participants experiencing at least one component of the composite endpoint.
All-cause mortality(Death from any cause).
Unit of Measure: Number (%)
Volume and incidence of perioperative allogeneic blood product transfusion
Unit of Measure: Number (%)
Total Volume of Allogeneic Blood Products Transfused
Unit of Measure: mL
Incidence of other severe complications, including new-onset perioperative renal failure, severe hepatic dysfunction, myocardial infarction, ischemic stroke, and thromboembolic events
Unit of Measure: Number (%)
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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
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