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 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT04306757
Eligibility Criteria:
Inclusion Criteria:
* Male and female subjects \>18 years
* Body weight \>40 kg
* Elective cardiac surgery with CPB and without ventilation during CPB
* American Society of Anaesthesiologists (ASA) risc classification I-IV
* Written informed consent
Exclusion Criteria:
* Emergency surgery
* Female subjects known to be pregnant
* Known participation in another interventional clinical trial
* High risk cardiac surgery such as double valve surgery, re-cardiac surgery, intraoperative cardiac arrest or pre-existing high grade cardiomyopathy (ejection fraction \<30%)
* Closing operation field without chest closure due to hemodynamic instability
* Acute endocarditis under antibiotic treatment
* Minimal invasive valve surgery via thoracotomy (MIC)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT04306757
Study Brief:
Protocol Section:
NCT04306757