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

NCT07284199 | Not Yet Recruiting

• 1 other identifier: 2025-08-CLEAR
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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.

  within 48 hours of the perioperative period

Secondary Outcomes (7)

• All-cause mortality(Death from any cause).

  From the end of surgery to 30 days postoperatively

• Volume and incidence of perioperative allogeneic blood product transfusion

  From the end of surgery to 30 days postoperatively

• Total Volume of Allogeneic Blood Products Transfused

  From the end of surgery to 30 days postoperatively

• Incidence of other severe complications, including new-onset perioperative renal failure, severe hepatic dysfunction, myocardial infarction, ischemic stroke, and thromboembolic events

  From the end of surgery to 30 days postoperatively

• ICU length of stay

  From the end of surgery to 30 days postoperatively

Study Arms (2)

CA330 Group

EXPERIMENTAL

CA330 Cytokine Adsorption Column and Standard Cardiopulmonary Bypass Management

Device: CA330 Cytokine Adsorption Column

non-CA330 Group

NO INTERVENTION

Standard Cardiopulmonary Bypass Management Alone

Interventions

CA330 Cytokine Adsorption Column DEVICE

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.

CA330 Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Patients with known bleeding risk due to hematologic disorders such as heparin-induced thrombocytopenia, hemophilia, or acute sickle cell crisis;
• Patients with severe infection, including severe sepsis.

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead
• Second Xiangya Hospital of Central South University: collaborator
• Henan Provincial Chest Hospital: collaborator
• Xiangya Hospital of Central South University: collaborator
• Shanghai Zhongshan Hospital: collaborator
• Wuhan Asia Heart Hospital: collaborator
• Xijing Hospital: collaborator
• West China Hospital: collaborator
• Guangdong Provincial People's Hospital: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• Army Medical University, China: collaborator
• Tongji Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• First Affiliated Hospital Xi'an Jiaotong University: collaborator

Study Sites (1)

Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100029, China

Location

MeSH Terms

Conditions

Aortic Dissection; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases; Heart Diseases

Study Officials

• Xiaotong Hou

  Beijing Anzhen Hospital

  STUDY CHAIR

Central Study Contacts

Xing Hao

CONTACT

+8664456328; haoxing131@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: December 16, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

CN (1)