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

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.

NCT Number	NCT07284199
Lead Sponsor	Beijing Anzhen Hospital Collaborators: Shanghai Zhongshan Hospital, Wuhan Asia Heart Hospital, Xijing Hospital, West China Hospital, Guangdong Provincial People's Hospital, Second Xiangya Hospital of Central South University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Henan Provincial Chest Hospital, Army Medical University, China, Tongji Hospital, Xiangya Hospital of Central South University, The First Affiliated Hospital of Zhengzhou University, First Affiliated Hospital Xi'an Jiaotong University
Conditions	CABG, Aortic Dissection, Valvular Heart Diseases
Enrollment	120 participants
Start Date	2025-12-15
Primary Completion	2027-12-31 (estimated)
Study Completion	2028-06-30 (estimated)
Updated on ClinicalTrials.gov	2025-12-16