Selective depletion of the C-reactive protein by means of therapeutic CRP apheresis to reduce myocardial damage after coronary bypass surgery
- Conditions
- I25Chronic ischaemic heart disease
- Registration Number
- DRKS00013012
- Lead Sponsor
- Pentracor GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 44
• 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
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)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Tissue damage of the heart.<br>Determination (daily) by the biomarker Troponin I (hsTnI) up to 96 h after the bypass surgery.
- Secondary Outcome Measures
Name Time Method Safety of CRP apheresis:<br>In order to assess the safety, a continuous monitoring of the vital parameters of blood pressure, heart rate and oxygen saturation as well as the general condition of the participants during the treatments are carried out.<br><br>Cardiac events up to hospital discharge:<br> - Cardiac arrhythmias<br> - Perioperative myocardial infarction (PMI)<br> - Cardiopulmonary resuscitation (CPR)<br> - Low cardiac output syndrome (LCOS)<br> - Re-operation<br> - Percutaneous coronary intervention (PCI)<br> - Angina pectoris<br><br>Tissue damage of the heart until 72 h after bypass surgery:<br> - Creatine kinase, MB fraction (CK-MB)<br> - Heart-type Fatty Acid Binding Protein (hFABP)<br> - Procalcitonin<br> - Myoglobin<br> - Leukocytes<br> - Interleukin-6 (IL-6)