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 @ 9:26 PM
Ignite Modification Date:
2025-12-24 @ 9:26 PM
NCT ID:
NCT01946932
Eligibility Criteria:
Inclusion Criteria:
* Age 18 years or older
* Out-of-Hospital Cardiac Arrest (OHCA)of presumed cardiac cause
* Unconsciousness after sustained return of spontaneous circulation (ROSC)
Exclusion Criteria at time for inclusion in the TTM study:
* Known bleeding diathesis
* Suspected or confirmed acute intracranial bleeding
* Suspected or confirmed stroke
* Unwitnessed asystole
* Known limitations in therapy and Do Not Resuscitate-order
* Known disease making 180 days survival unlikely
* Known prearrest status Cerebral Performance Category (CPC)3 or 4
* Temperature \<30°on admission
* 4 hours (240 minutes) from ROSC to screening
* Systolic blood pressure \<80 mm Hg in spite of fluid loading/vasopressor and/or inotropic medication/intra aortic balloon pump
* In-hospital cardiac arrest
* OHCA of presumed non-cardiac arrest cause
Additional Exclusion criteria for the sub-study:
* Disability to speak the site language well enough to complete tests without interpreter
* Controls should never have suffered a cardiac arrest
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01946932
Study Brief:
Protocol Section:
NCT01946932