A Multicenter Randomized Controlled Trial of the CA330 Haemoadsorption Device in Patients for Limiting Excess Anticoagulation in Non-elective caRdiac Surgery With Cardiopulmonary Bypass
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- incidence of BARC-4 severe bleeding
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
incidence of BARC-4 severe bleeding
时间窗: 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.
次要结局
- Hospitalization costs(From the end of surgery to 30 days postoperatively)
- Hospital length of stay(From the end of surgery to 30 days postoperatively)
- 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)
研究者
Xiaotong Hou
Professor
Beijing Anzhen Hospital