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 @ 4:54 AM
Ignite Modification Date:
2025-12-25 @ 4:54 AM
NCT ID:
NCT02685618
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥18 years
2. OHCA of presumed cardiac cause
3. Sustained ROSC\*
4. Unconsciousness (GCS \<8) (patients not able to obey verbal commands) after sustained ROSC\*
5. Target temperature management is indicated.
Exclusion Criteria:
1. Conscious patients (obeying verbal commands)
2. Females of childbearing potential (unless a negative human chorionic gonadotropin (HCG) test can rule out pregnancy within the inclusion window)
3. Patients weighing more than 135kg
4. In-hospital cardiac arrest (IHCA)
5. 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).
6. Known congenital bleeding diathesis (medically induced coagulopathy due to treatment with Vitamin K antagonists, Thrombininhibitors, Factor Xa inihbitors, ADP-receptor inhibitors, Aspirin, Asasantin, Persantin, NSAID, unfractionated and low molecular weight heparin does NOT exclude the patient).
7. Suspected or confirmed acute intracranial bleeding
8. Suspected or confirmed acute stroke
9. Unwitnessed asystole
10. Known limitations in therapy and Do Not Resuscitate-order
11. Known disease making 180 days survival unlikely
12. Known pre-arrest CPC 3 or 4
13. \>4 hours (240 minutes) from ROSC to screening
14. Systolic blood pressure \<80 mm Hg in spite of fluid loading/vasopressor and/or inotropic medication/intra-aortic balloon pump/axial flow device\*
15. Temperature on admission \<30°C.
16. Known allergy to Prostacyclin analogues
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02685618
Study Brief:
Protocol Section:
NCT02685618