Selective Depletion of C-reactive Protein by Therapeutic Apheresis (CRP Apheresis) After Elective Primary Coronary Bypass Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Tissue damage of the heart
研究概览
简要总结
The CABY1 study is conducted open, controlled, randomized and monocentric. The efficacy and tolerability of CRP apheresis in patients undergoing elective primary coronary bypass surgery is investigated.
详细描述
CABY1 is a clinical trial to study the reduction of C-reactive protein (CRP) by therapeutic apheresis (CRP apheresis) in patients undergoing elective primary coronary bypass surgery.
The term therapeutic apheresis describes therapeutical procedures whose effect is based on the elimination of blood components with a pathogenic function within the disease process. Elimination takes place in adsorbers outside the body in an extracorporeal circuit. To remove the pathogenic substances, blood plasma is separated from the circuit and passed through an adsorber. The purified blood plasma is then reunited with the solid blood components and returned to the patient.
The "PentraSorb® CRP" adsorber used for CRP apheresis is CE-certified. It serves for the selective depletion of the C-reactive protein from human plasma.
As a cause of the damaging effect of the C-reactive protein it is assumed that the CRP as an inflammatory mediator favours the destruction of cardiac muscle tissue (in conjunction with complement) and has a negative influence on the regeneration of the traumatized tissue.
The aim of the CABY1 study is to investigate if the tissue damage of the heart can be reduced by depletion of the C-reactive protein after elective coronary bypass surgery. A possible protective effect of CRP apheresis will be determined from laboratory biomarkers (e.g., troponin I, CM-MB, IL-6) and cardiac events.
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
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elective, isolated, primary coronary bypass surgery
- •2 or 3-fold CHD with or without main stem stenosis
- •Obtained LVEF (> 30%, trans-oesophageal echocardiography (TEE) or angiography)
- •Heart-lung machine (HLM; 'two-stage' cannulation)
- •Antegrade Bretschneider cardioplegia
- •Mild hypothermia (32 °C)
- •Standard anesthesia (isoflurane)
- •Intraoperative standard protocol (500 mg ASA after 2 h, low dose heparinization after 4 h)
- •written informed consent
- •legal capacity
排除标准
- •Preoperatively
- •PCI (within last 2 weeks)
- •Renal insufficiency (creatinine > 1.3 mmol/L or requiring dialysis)
- •Combination interventions
- •Re-surgery
- •Emergency of urgent surgery indication
- •Acute coronary syndrome (IAP, NSTEMI, STEMI)
- •Preoperatively positive hs-troponin I > 40 ng/ml
- •Chronic arterial fibrillation
- •Acute infectious disease (body temperature > 38.0°C)
- •Systolic blood pressure < 100 mmHg
- •Known hypersensitivity to therapeutic apheresis
- •Cardiac shock
- •Pregnancy or lactation
- •Participation in other interventional trial
- •During surgery
- •Radialis removal
- •Coronary TEA (if blood flow within bypass < 20 ml/min)
- •Hemofiltration
- •Combination intervention (e.g. mitral valve reconstruction, LAA)
- •Maze procedure
- •Bypass low-flow closure, ECG changes
- •Antithrombotic therapy (intraoperative clopidogrel and/or aspirin)
- •Second HLM
- •Second cardioplegic cardiac arrest
- •Intraaortal balloon pumping / balloon pulsation (IABP)
- •Extracorporeal membrane oxygenation (ECMO)
结局指标
主要结局
Tissue damage of the heart
时间窗: Every 24 hours for up to 96 hours after bypass surgery
Daily determination of the concentration of the biomarker Troponin I (hsTnI)
次要结局
- Cardiac events(Until the patient is discharged from the hospital, an average of 7 days)
- Tissue damage of the heart with Procalcitonin(Every 24 hours for 72 hours after bypass surgery)
- Tissue damage of the heart with Myoglobin(Every 24 hours for 72 hours after bypass surgery)
- Safety of CRP apheresis(24 hours after each apheresis)
- Tissue damage of the heart with CK-MB(Every 24 hours for 72 hours after bypass surgery)
- Tissue damage of the heart with Interleukin-6(Every 24 hours for 72 hours after bypass surgery)
- Tissue damage of the heart with Leukocytes(Every 24 hours for 72 hours after bypass surgery)