CABGCLEARNCT07284199
CLEAR Trial: CA330 Cytokine Adsorption Column for Anticoagulant/Antiplatelet Patients in Non-Elective CPB Surgery.
A study testing CA330 Cytokine Adsorption Column in people with CABG and Aortic Dissection, run by Beijing Anzhen Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- CABG, Aortic Dissection, Valvular Heart Diseases
- What is being tested?
- CA330 Cytokine Adsorption Column
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2025to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029
About this study
Official title: A Multicenter Randomized Controlled Trial of the CA330 Haemoadsorption Device in Patients for Limiting Excess Anticoagulation in Non-elective caRdiac Surgery With Cardiopulmonary Bypass
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:
Read more
- 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.
Read the detailed description
- 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.
- Secondary Objectives:
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:
- Standard anesthesia and surgical procedures will be applied.
- CPB will be established using standardized management protocols based on guidelines and expert consensus.
- In the intervention group, CA330 will be integrated into the CPB circuit; the control group will receive standard CPB management without the device.
- Drug concentrations will be measured at:
- T0: end of anesthesia induction
- T1: initiation of CPB
- T2: 30 min after CPB
- T3: 60 min after CPB
- T4: 120 min after CPB
- T5: before weaning from CPB
- T6: after protamine administration
- Coagulation profile (five-item coagulation test) will be measured preoperatively and within 24h post-ICU admission.
- Blood gas analysis will be performed at T0, T2, T5, and T6.
- Outcome Measures:
- Primary Endpoint: Incidence of BARC (Bleeding Academic Research Consortium) type 4 bleeding.
- Secondary Endpoints:
- Perioperative transfusion rate and volume of allogeneic blood products
- Duration of mechanical ventilation
- ICU length of stay
- Total hospital length of stay
- Hospital costs
- Incidence of severe perioperative complications, including acute renal failure, severe hepatic dysfunction, myocardial infarction, ischemic stroke, and thromboembolic events.
- 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.
- Sample Size:
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.
- Conditions
- CABG, Aortic Dissection, Valvular Heart Diseases
- Being tested
- CA330 Cytokine Adsorption Column
- Medical subject headings
- Aortic Dissection, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CA330 Cytokine Adsorption ColumnDevice
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 group | Role | What they receive |
|---|---|---|
| CA330 Group | Experimental | CA330 Cytokine Adsorption Column and Standard Cardiopulmonary Bypass Management Receives: Device: CA330 Cytokine Adsorption Column |
| non-CA330 Group | No intervention | Standard Cardiopulmonary Bypass Management Alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of BARC-4 severe bleeding
The primary endpoint is a composite outcome, defined as the occurrence of any one of the following events:
- Intracranial hemorrhage within 48 hours of the perioperative period(Number);
- Reoperation after sternotomy closure to control bleeding(Number);
- Transfusion of ≥5 units (1,000 mL) of whole blood or packed red blood cells within 48 hours(Number);
- Postoperative chest drainage ≥2 L within 24 hours(Number).
Unit of measure: number of participants experiencing at least one component of the composite endpoint.
Measured: within 48 hours of the perioperative period
Secondary outcomes (7)
All-cause mortality(Death from any cause).
Unit of Measure: Number (%)
Measured: From the end of surgery to 30 days postoperatively
Volume and incidence of perioperative allogeneic blood product transfusion
Unit of Measure: Number (%)
Measured: From the end of surgery to 30 days postoperatively
Total Volume of Allogeneic Blood Products Transfused
Unit of Measure: mL
Measured: 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 (%)
Measured: From the end of surgery to 30 days postoperatively
ICU length of stay
Unit of Measure: Days
Measured: From the end of surgery to 30 days postoperatively
Hospital length of stay
Unit of Measure: Days
Measured: From the end of surgery to 30 days postoperatively
Hospitalization costs
Unit of Measure: CNY
Measured: From the end of surgery to 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start15 Dec 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CABGStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Xiaotong Hou, Beijing Anzhen Hospital
- Investigators
- Xiaotong Hou, Study chair, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07284199
- Sponsor's protocol ID
- 2025-08-CLEAR
- Acronym
- CLEAR
- Status last verified
- Dec 2025
- First submitted
- 26 Sep 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Controlled Trial of the CA330 Haemoadsorption Device in Patients for Limiting Excess Anticoagulation in Non-elective caRdiac Surgery With Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT07284199
- Acronym / sponsor ID
- CLEAR / 2025-08-CLEAR
- Conditions
- CABG, Aortic Dissection, Valvular Heart Diseases
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- 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
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
- Secondary Objectives:
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:
- Standard anesthesia and surgical procedures will be applied.
- CPB will be established using standardized management protocols based on guidelines and expert consensus.
- In the intervention group, CA330 will be integrated into the CPB circuit; the control group will receive standard CPB management without the device.
- Drug concentrations will be measured at:
- T0: end of anesthesia induction
- T1: initiation of CPB
- T2: 30 min after CPB
- T3: 60 min after CPB
- T4: 120 min after CPB
- T5: before weaning from CPB
- T6: after protamine administration
- Coagulation profile (five-item coagulation test) will be measured preoperatively and within 24h post-ICU admission.
- Blood gas analysis will be performed at T0, T2, T5, and T6.
- Outcome Measures:
- Primary Endpoint: Incidence of BARC (Bleeding Academic Research Consortium) type 4 bleeding.
- Secondary Endpoints:
- Perioperative transfusion rate and volume of allogeneic blood products
- Duration of mechanical ventilation
- ICU length of stay
- Total hospital length of stay
- Hospital costs
- Incidence of severe perioperative complications, including acute renal failure, severe hepatic dysfunction, myocardial infarction, ischemic stroke, and thromboembolic events.
- 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.
- Sample Size:
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CA330 Group | Experimental | Device: CA330 Cytokine Adsorption ColumnCA330 Cytokine Adsorption Column and Standard Cardiopulmonary Bypass Management |
| non-CA330 Group | No intervention | –Standard Cardiopulmonary Bypass Management Alone |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CA330 Cytokine Adsorption ColumnCA330 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. | Device | CA330 Group |
Primary outcome
incidence of BARC-4 severe bleeding
Time frame: 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.
7 secondary outcomes
All-cause mortality(Death from any cause).
Time frame: From the end of surgery to 30 days postoperatively
Volume and incidence of perioperative allogeneic blood product transfusion
Time frame: From the end of surgery to 30 days postoperatively
Total Volume of Allogeneic Blood Products Transfused
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
Time frame: From the end of surgery to 30 days postoperatively
ICU length of stay
Time frame: From the end of surgery to 30 days postoperatively
Hospital length of stay
Time frame: From the end of surgery to 30 days postoperatively
Hospitalization costs
Time frame: From the end of surgery to 30 days postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaotong Hou study chair
Beijing Anzhen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CA330 Cytokine Adsorption Column in people with CABG and Aortic Dissection, run by Beijing Anzhen Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xing Hao (+8664456328, haoxing131@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of BARC-4 severe bleeding (time frame: within 48 hours of the perioperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.