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 @ 7:32 PM
Ignite Modification Date:
2025-12-24 @ 7:32 PM
NCT ID:
NCT07086703
Eligibility Criteria:
Inclusion Criteria:
* IHCA (unwitnessed IHCA with initial asystole; these patients may still be eligible if visible or audible signs of life were witnessed within 10 minutes after IHCA (no-flow duration ≤10 minutes, in keeping with the non-inclusion criteria for HYPERION study).
* Sustained ROSC (Return Of Spontaneous Circulation) defined as signs of circulation for 20 minutes without chest compressions
* At least 1 mg of epinephrine
* Coma defined as an inability to obey verbal commands (Glasgow Coma Scale motor response \<6 or Full Outline of UnResponsiveness (FOUR) score motor response \<4) after sustained ROSC
* Eligible for intensive care without restrictions or limitations
* Inclusion within 90 minutes of ROSC
* Age 18 years or older
* Next of kin informed about the trial and having consented to participation of the patient in the trial (patients with coma are unable to consent). If no next of kin can be contacted during screening for the study, trial inclusion will be completed as an emergency procedure by the ICU physician, in compliance with Country of inclusion law.
* Healthcare costs covered by the French statutory healthcare insurance system
Exclusion Criteria:
* Temperature at admission \<30°C
* Obvious or suspected pregnancy
* Intracranial bleeding
* Dependent on others for activities of daily living before hospitalization
* Patient under curators, guardianship or under protection of justice
* Correctional facility inmate
* Patient who does no speak French
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07086703
Study Brief:
Protocol Section:
NCT07086703