Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2025-12-24 @ 5:33 PM
NCT ID:
NCT04745468
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04745468
Study Brief:
Protocol Section:
NCT04745468