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ClinicalTrials.gov ID

NCT03176186

Lead Sponsor

Invero Pharma, Inc.INDUSTRY

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 3

Enrollment

1,436Estimated

Last Update Posted

Apr 3, 2025Actual

Start Date

Mar 2026Estimated

Primary Completion Date

Apr 2029Estimated

Completion Date

May 2030Estimated

Official Title

XePOHCAS - Xenon by Inhalation for Post Out of Hospital Cardiac Arrest Syndrome

Brief Summary

XePOHCAS: Prospective, randomized, multicenter interventional trial in adult subjects with out-of-hospital cardiac arrest comparing treatment with standard-of-care post-cardiac arrest intensive care (which is targeted temperature management [TTM]) to xenon by inhalation plus standard-of-care post-cardiac arrest intensive care (including TTM).

Detailed Description

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).

• Post-Cardiac Arrest Syndrome

• Xenon

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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)

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

Invero Pharma, Inc.INDUSTRY

rmstein3@buffalo.edu716-888-4859