I25
Conditions
Interventions
Group 1: 20 patients receive 2 apheresis treatments at intervals of 24 ± 12 hrs (additionally to the standard therapy after bypass surgery). The first treatment starts within 24 hours postoperatively.
Sponsors
Pentracor GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 79 Years
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: Preoperatively • Age 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tissue damage of the heart. Determination (daily) by the biomarker Troponin I (hsTnI) up to 96 h after the bypass surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of CRP apheresis: 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. Cardiac events up to hospital discharge: - Cardiac arrhythmias - Perioperative myocardial infarction (PMI) - Cardiopulmonary resuscitation (CPR) - Low cardiac output syndrome (LCOS) - Re-operation - Percutaneous coronary intervention (PCI) - Angina pectoris Tissue damage of the heart until 72 h after bypass surgery: - Creatine kinase, MB fraction (CK-MB) - Heart-type Fatty Acid Binding Protein (hFABP) - Procalcitonin - Myoglobin - Leukocytes - Interleukin-6 (IL-6) | — |
Countries
Germany
Contacts
Public ContactMatthias Thielmann
Klinik für Thorax- und Kardiovaskuläre ChirurgieWestdeutsches Herz- und Gefäßzentrum Essen
Outcome results
None listed