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 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT05029167
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years
* OHCA of presumed cardiac cause
* Sustained ROSC
* Unconsciousness (Glasgow coma scale \<8) after sustained ROSC
Exclusion Criteria:
* Conscious patients (obeying verbal commands)
* Females of childbearing potential (unless a negative HCG test can rule out pregnancy within the inclusion window)
* In-hospital cardiac arrest
* OHCA of presumed non-cardiac cause e.g. after trauma or dissection/rupture of major artery or cardiac arrest caused by initial hypoxia (i.e. drowning, suffocation, hanging).
* Known bleeding diathesis (medically induced coagulopathy (e.g. warfarin, NOAC, clopidogrel) does not exclude the patient)
* Suspected or confirmed acute intracranial bleeding
* Suspected or confirmed acute stroke
* Unwitnessed asystole
* Known limitations in therapy and Do Not Resuscitate-order
* Known disease making 180 days survival unlikely
* Known pre-arrest cerebral performance category 3 or 4
* \>4 hours (240 minutes) from ROSC to screening
* Systolic blood pressure \<80 mmHg in spite of fluid loading/vasopressor and/or inotropic medication/intra-aortic balloon pump/axial flow device
* Temperature on admission \<30°C
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05029167
Study Brief:
Protocol Section:
NCT05029167