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

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.

Conditions

• CABG
• Aortic Dissection
• Valvular Heart Diseases

Interventions

DEVICE

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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital

  collaborator OTHER

• Wuhan Asia Heart Hospital

  collaborator OTHER

• Xijing Hospital

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• Guangdong Provincial People's Hospital

  collaborator OTHER

• Second Xiangya Hospital of Central South University

  collaborator OTHER

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

  collaborator OTHER

• Henan Provincial Chest Hospital

  collaborator OTHER

• Army Medical University, China

  collaborator OTHER

• Tongji Hospital

  collaborator OTHER

• Xiangya Hospital of Central South University

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• First Affiliated Hospital Xi'an Jiaotong University

  collaborator OTHER

• Beijing Anzhen Hospital

  lead OTHER

Principal Investigators

• Xiaotong Hou · Beijing Anzhen Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-15

Primary Completion

2027-12-31

Completion

2028-06-30

Countries

• China

Study Locations