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 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT05706194
Eligibility Criteria:
Inclusion Criteria:
Adult cardiac arrest patients with an out-of-hospital cardiac arrest of non-traumatic cause treated at hospitals recruiting patients to the STEPCARE neuroprognostication substudy. Other inclusion criteria include:
* a minimum of 20 minutes without chest compressions
* Unconsciousness defined as not being able to obey verbal commands (FOUR-score motor response of \<4) or being intubated and sedated because of agitation after sustained ROSC
* Eligible for intensive care without restrictions or limitations
* Inclusion within 4 hours of ROSC
Exclusion Criteria:
* On ECMO prior to randomisation
* Pregnancy
* Suspected or confirmed intracranial hemorrhage
* Previously randomised in the STEPCARE trial
* Patients with limitations in level-of-care due to for example generalized malignancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT05706194
Study Brief:
Protocol Section:
NCT05706194