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Clinical Trials in the USA / NCT03176186
Starting soon Phase 3

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

NCT03176186 · tracked via the Priya Life Science USA tracker
Sponsor
Invero Pharma, Inc.
Phase
Phase 3
Started
2026-03
Last updated
2025-04-03

Condition(s) studied

Post-Cardiac Arrest Syndrome

Investigational drug(s) / intervention(s)

Xenon

Xenon: 50% xenon by inhalation, delivered by customized xenon delivery system, that includes a ventilator, for the 24h period of TH/TTM. The inhalation therapy is provided in combination with protocol-directed Post-Cardiac Arrest Care dictated by the 2015 guidelines from the American Heart Association and the European Resuscitation Council.

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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 outcome measure(s)

Trial sites (10)

FacilityCityRegionStatus
Hartford Hospital Hartford Connecticut
University of Florida Gainesville Florida
Memorial Hospital at Gulfport Gulfport Mississippi
University Nebraska Medical Center Omaha Nebraska
University at Buffalo Buffalo New York
Wexner Medical Center, Ohio State University Columbus Ohio
Baptist Memorial Hospital, Baptist Clinical Research Institute Memphis Tennessee
Houston Methodist Research Institute Houston Texas
Aalborg University Hospital Aalborg Denmark
University Hospital, Rigshospitalet, Blegdamsvej 9 Copenhagen Denmark
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03176186 on ClinicalTrials.gov ↗ ← All trials in the USA