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 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT02631304
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent
* ≥ 65 years of age
* Scheduled to undergo elective cardiac surgery (coronary artery bypass graft (CABG), valve surgery, combined CABG-valve surgery) with the use of CPB
* Both genders
Exclusion Criteria:
* Planned deep hypothermic arrest
* Acute / emergency procedures
* Surgery without extracorporeal circulation (ECC)
* Patients with a history of pseudocholinesterase deficiency
* Employees of the respective study centres
* Illiteracy
* Severe communication difficulties and severe vision or hearing problems
* Patients legally unable to give written informed consent
* non-fluency in German language
* Severe psychiatric or neuropsychiatric disorders
* MMSE \< 24 points, short geriatric depression scale (GDS) ≥ 10 points
* Recent (\<6 months) history of alcohol or drug abuse
* The participation in a drug or device trial within the previous 30 days
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT02631304
Study Brief:
Protocol Section:
NCT02631304