DRKS00013012已完成未知
Selective depletion of the C-reactive protein by means of therapeutic CRP apheresis to reduce myocardial damage after coronary bypass surgery - CABY1
Pentracor GmbH0 个研究点目标入组 44 人开始时间: 2017年9月15日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 44
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 79 Years（—）
- 性别
- All
入选标准
- •elective, isolated, primary coronary bypass surgery
- •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 (complete heparinization with ACT > 400 s, tranexamic acid, protamine)
- •Postoperative standard protocol (500 mg ASA after 2 h, low dose heparinization after 4 h)
- •written informed consent
- •legal capacity
排除标准
- •Preoperatively
- •Age <18 = 80 years
- •PCI (within the last 2 weeks)
- •Renal insufficiency (creatinine > 1.3 mmol / L)
- •Combination interventions
- •Reoperation
- •Emergency or urgent surgery indication
- •Acute coronary syndrome (IAP, NSTEMI, STEMI)
- •Preoperatively positive hs-troponin I > 40 ng / ml
- •Chronic atrial fibrillation
- •Acute infectious disease (body temperature (auricular, sublingual) > 38.0 °C)
- •Systolic blood pressure < 100 mmHg
- •Known hypersensitivity to therapeutic aphereses
- •Cardiac shock
- •Renal insufficiency requiring dialysis (see above)
- •Pregnancy or lactation
- •Participation in other interventional trial
- •During surgery:
- •Radialis removal
- •Coronary TEA (thrombendarteriectomy)
- •Off-pump
- •Hemofiltration
- •Combination intervention (e.g., mitral valve reconstruction (MKR), LAA (Left Auriculus Atrii))
- •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)
研究者
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