An interventional study of CA330 Cytokine Adsorption Column in CABG, Aortic Dissection and Valvular Heart Diseases, sponsored by Beijing Anzhen Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-12-16.
Sponsored by Beijing Anzhen Hospital · Not applicable, Interventional, and Treatment
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:
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:
I. Study Background
Anticoagulant and antiplatelet agents reduce the risk of thrombosis by inhibiting platelet aggregation or coagulation factor activity, but they significantly increase the risk of intraoperative and postoperative bleeding. In urgent or emergency surgery, patients may be unable to discontinue anticoagulant or antiplatelet therapy in time, leading to markedly higher rates of bleeding complications during and after surgery. This presents major challenges for perioperative management and seriously affects patient outcomes.
The CA330 cytokine adsorption column is a novel hemoperfusion device that removes specific substances from the blood via adsorption during cardiopulmonary bypass (CPB). This study aims to evaluate the efficacy of CA330 in reducing perioperative severe bleeding adverse events during non-elective cardiac surgery under CPB in patients receiving anticoagulant or antiplatelet therapy. The ultimate goal is to provide a safer and more effective surgical strategy, improve patient prognosis, and generate high-level evidence for clinical practice.
II. Study Objectives
Primary Objective:
To evaluate the efficacy of CA330 in reducing perioperative severe bleeding adverse events during non-elective cardiac surgery with CPB in patients receiving anticoagulant or antiplatelet therapy, thereby providing a safer and more effective surgical strategy.
By comparing perioperative outcomes and drug concentration monitoring between the intervention and control groups, to clarify the clearance efficiency of CA330 for different drugs during non-elective cardiac surgery with CPB, and to provide valuable guidance for clinical practice.
III. Study Protocol
Enrollment and Randomization:
Eligible patients will be enrolled, randomized 1:1 into the intervention and control groups, provide written informed consent, and have baseline preoperative data collected.
Intervention and Procedures:
Outcome Measures:
Incidence of BARC (Bleeding Academic Research Consortium) type 4 bleeding.
Statistical Analysis:
Comparative analyses will be performed between groups to assess differences in perioperative and follow-up outcomes, thereby determining the safety and efficacy of CA330 in non-elective cardiac surgery with CPB among patients receiving anticoagulant or antiplatelet therapy, and to guide optimal clinical management.
A total of 120 patients are planned for enrollment. After enrollment of the first 60 patients, an interim analysis will be conducted based on observed endpoint outcomes to re-estimate sample size. The final sample size will not exceed 200 patients.
205 studies on the registry are indexed under Aortic Dissection; 73 are open to participants now.
This study's planned enrollment of 120 is close to the median of 114 across 86 interventional studies indexed under Aortic Dissection.
Browse Aortic Dissection studies →Beijing Anzhen Hospital is the lead sponsor of 192 studies on the registry; 102 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CA330 Cytokine Adsorption Column and Standard Cardiopulmonary Bypass Management
Device: CA330 Cytokine Adsorption Column
Standard Cardiopulmonary Bypass Management Alone
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.
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.
Time frame: within 48 hours of the perioperative period
All-cause mortality(Death from any cause).
Unit of Measure: Number (%)
Time frame: From the end of surgery to 30 days postoperatively
Volume and incidence of perioperative allogeneic blood product transfusion
Unit of Measure: Number (%)
Time frame: From the end of surgery to 30 days postoperatively
Total Volume of Allogeneic Blood Products Transfused
Unit of Measure: mL
Time frame: 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
Unit of Measure: Number (%)
Time frame: From the end of surgery to 30 days postoperatively
ICU length of stay
Unit of Measure: Days
Time frame: From the end of surgery to 30 days postoperatively
Hospital length of stay
Unit of Measure: Days
Time frame: From the end of surgery to 30 days postoperatively
Hospitalization costs
Unit of Measure: CNY
Time frame: From the end of surgery to 30 days postoperatively
Start is estimated for Dec 2025; primary completion for Dec 2027, 24 months later.
Of 49 interventional studies with no phase under Aortic Dissection, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23. This study's planned 24 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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