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

Condition(s) studied

Investigational drug(s) / intervention(s)

CA330 Cytokine Adsorption Column: CA330 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.

Study summary

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

Primary outcome measure(s)

• incidence of BARC-4 severe bleeding — within 48 hours of the perioperative period
  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.

Trial sites (1)

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