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:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT02231060
Eligibility Criteria:
Inclusion Criteria:
* Age between 18 and 85 years
* Cause of admission to ICU: cardiac arrest (in or out of hospital)
* Glasgow-Coma-Scale \< 9 at time of study enrolment (3 to 8 days after cardiac arrest)
* Informed consent signed by legal guardian/next-of-kin
Exclusion Criteria:
* Stroke (as it may interfere with SSEP testing)
* Pre-existing coma/vegetative state/minimally conscious state
* Terminal malignant disease
* Survival in the next 12 months extremely unlikely
* Existing advanced directive that demands cessation of therapy/life support
* Palliative care/withdrawal of life support during treatment at the ICU
* Barbiturate-induced general anesthesia during the first 3 days after cardiac arrest
* Impossibility of assessing current level of consciousness with the Glasgow Coma Scale due to a long-term deep sedation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT02231060
Study Brief:
Protocol Section:
NCT02231060