Status:
COMPLETED
Study on CRP Apheresis After Coronary Bypass Surgery
Lead Sponsor:
Pentracor GmbH
Conditions:
Post-cardiac Surgery
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
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 investigate...
Detailed Description
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 therape...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
- Off-pump
- 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)
Key Trial Info
Start Date :
March 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 28 2021
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT04745468
Start Date
March 21 2018
End Date
January 28 2021
Last Update
October 18 2022
Active Locations (1)
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1
Klinik für Thorax- und Kardiovaskuläre Chirurgie
Essen, Germany, 45122