Xenon for Neuroprotection During Post-Cardiac Arrest Syndrome in Comatose Survivors of an Out of Hospital Cardiac Arrest

XePOHCAS:

Primary Objective:

To evaluate whether there is a difference in functional outcome with xenon 50% and oxygen
during targeted temperature management (TTM) compared with similar oxygen content in air
during TTM in comatose subjects with sustained restoration of spontaneous circulation (ROSC)
within 30 minutes after out-of-hospital cardiac arrest (OHCA).

Secondary Objective:

To evaluate whether there is a difference in survival with xenon 50% and oxygen during
targeted temperature management (TTM) compared with similar oxygen content in air during TTM
in comatose subjects with sustained restoration of spontaneous circulation (ROSC) within 30
minutes after out-of-hospital cardiac arrest (OHCA).

Inclusion Criteria:

1. Age at least 18 years but less than or equal to 80 years

2. Presumed cardiac cause of arrest

3. Sustained (>20 minutes) spontaneous circulation upon arrival in the emergency
department

4. No response to verbal commands on arrival to emergency department and prior to
randomization (Glasgow Coma Scale score of <8)

5. Attending decision that patient is eligible for TTM

Exclusion Criteria:

1. Written do not attempt resuscitation reported to providers before randomization

2. Traumatic etiology of arrest, defined as concomitant blunt, penetrating, or
burn-related injury, or uncontrolled bleeding or exsanguination

3. Suspected or known stroke or intracranial hemorrhage

4. Unwitnessed cardiac arrest

5. No-flow (cardiac arrest to initiation of cardiopulmonary resuscitation/defibrillation)
time of >10 minutes

6. Sustained restoration of spontaneous circulation (ROSC) greater than 30- minutes
post-arrest

7. Interval from arrival at the emergency department to randomization for intervention of
>4 hours.

8. Hypothermia (<30°C core temperature)

9. Bed-bound prior to cardiac arrest

10. Unconsciousness before cardiac arrest (cerebral trauma, spontaneous cerebral
hemorrhage, intoxication etc.)

11. Coagulopathy

12. Systolic arterial pressure <80 mmHg or mean arterial pressure <60 mmHg lasting more
than 30 minutes after ROSC

13. Known pregnancy

14. Have received an investigational drug, device, or biologic product within 30-days

15. Known terminal phase of chronic illness

16. Hypoxemia (SaO2 <85%) for >15 minutes after ROSC

17. Inability to maintain SaO2 >90% on an FiO2 of 50%

18. Having any other clinically significant laboratory abnormality, medical condition
(such as intrinsic liver disease or severe chronic obstructive pulmonary disease), or
social circumstance that, in the investigator's opinion, makes it inappropriate for
the patient to participate in this clinical trial

19. Logistically impossible to provide intervention

20. Have any condition that would impact the evaluation of modified Rankin Scale (mRS)