What this study is
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).
What's being tested
- Xenon
Intervention · COMBINATION PRODUCT
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 details
- Official title
- XePOHCAS - Xenon by Inhalation for Post Out of Hospital Cardiac Arrest Syndrome
- Sponsor
- Invero Pharma, Inc.
- Conditions
- Post-Cardiac Arrest Syndrome
- Enrolling
- 1,436 people
- Starts
- 2026-03
- Est. completion
- 2030-05
- Design
- Single-blind, randomized, parallel groups, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 80 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Age at least 18 years but less than or equal to 80 years
- Presumed cardiac cause of arrest
- Sustained (>20 minutes) spontaneous circulation upon arrival in the emergency department
- No response to verbal commands on arrival to emergency department and prior to randomization (Glasgow Coma Scale score of <8)
- Attending decision that patient is eligible for TTM
You can't join if
- Written do not attempt resuscitation reported to providers before randomization
- Traumatic etiology of arrest, defined as concomitant blunt, penetrating, or burn-related injury, or uncontrolled bleeding or exsanguination
- Suspected or known stroke or intracranial hemorrhage
- Unwitnessed cardiac arrest
- No-flow (cardiac arrest to initiation of cardiopulmonary resuscitation/defibrillation) time of >10 minutes
- Sustained restoration of spontaneous circulation (ROSC) greater than 30- minutes post-arrest
- Interval from arrival at the emergency department to randomization for intervention of >4 hours.
- Hypothermia (<30°C core temperature)
- Bed-bound prior to cardiac arrest
- Unconsciousness before cardiac arrest (cerebral trauma, spontaneous cerebral hemorrhage, intoxication etc.)
- Coagulopathy
- Systolic arterial pressure <80 mmHg or mean arterial pressure <60 mmHg lasting more than 30 minutes after ROSC
- Known pregnancy
- Have received an investigational drug, device, or biologic product within 30-days
- Known terminal phase of chronic illness
- Hypoxemia (SaO2 <85%) for >15 minutes after ROSC
- Inability to maintain SaO2 >90% on an FiO2 of 50%
- 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
- Logistically impossible to provide intervention
- Have any condition that would impact the evaluation of modified Rankin Scale (mRS)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (10)
10 openHartford Hospital
Hartford, Connecticut, United States
- William Roman · ContactWilliam.Roman@hhchealth.org
- Antonio Fernandez, MD · Principal investigator
University of Florida
Gainesville, Florida, United States
Memorial Hospital at Gulfport
Gulfport, Mississippi, United States
- Brandy Williams · Contact228-575-2480bwilliams@mhg.com
- Katherine F. Green, BSN, RN · Contact228-575-2518kgreen@mhg.com
- Joseph R. Bosarge, M.D. · Principal investigator
University Nebraska Medical Center
Omaha, Nebraska, United States
- Lace D Sindt, BS · Contactlace.sindt@unmc.edu
- James N Sullivan, MD · Principal investigator
University at Buffalo
Buffalo, New York, United States
- Robin M. Stein, RN, BSN · Contact716-888-4859rmstein3@buffalo.edu
- Vijay Iyer, MD · Principal investigator
Wexner Medical Center, Ohio State University
Columbus, Ohio, United States
- January Kim, BS · Contact614-293-3559January.Kim@osumc.edu
- Uribe Alberto, MD · Principal investigator
Baptist Memorial Hospital, Baptist Clinical Research Institute
Memphis, Tennessee, United States
- Mildred Jenkins · ContactMildred.Jenkins@BMHCC.org
- Patricia Hopkins · Principal investigator
Houston Methodist Research Institute
Houston, Texas, United States
- Digant Jariwala · Contactdjariwala@houstonmethodist.org
- Janice Zimmerman, MD · Principal investigator
2 sites outside the US
Aalborg University Hospital
Aalborg, Denmark
University Hospital, Rigshospitalet, Blegdamsvej 9
Copenhagen, Denmark
Study team
Sponsor
Invero Pharma, Inc.
Study ID XePOHCAS Ph III
Study director
Steffen Stuerzebecher, M.D.
CMO Invero Pharma
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.