Post-Cardiac Arrest SyndromePhase 3XePOHCASNCT03176186
Xenon for Neuroprotection During Post-Cardiac Arrest Syndrome in Comatose Survivors of an Out of Hospital Cardiac Arrest
A Phase 3 study testing Xenon in people with Post-Cardiac Arrest Syndrome, run by Invero Pharma, Inc. at 10 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Post-Cardiac Arrest Syndrome
- What is being tested?
- Xenon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,436 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Mar 2026to May 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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)
Trial locations and contacts
10 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 2 countries
United States8 sites
University at Buffalo
Buffalo, New York, 14203
Robin M. Stein, RN, BSN, 716-888-4859, rmstein3@buffalo.edu
Vijay Iyer, MD
Wexner Medical Center, Ohio State University
Columbus, Ohio, 43210
January Kim, BS, 614-293-3559, January.Kim@osumc.edu
Uribe Alberto, MD
University of Florida
Gainesville, Florida, 32611
Memorial Hospital at Gulfport
Gulfport, Mississippi, 39503
Brandy Williams, 228-575-2480, bwilliams@mhg.com
Katherine F. Green, BSN, RN, 228-575-2518, kgreen@mhg.com
Hartford Hospital
Hartford, Connecticut, 06102
William Roman, William.Roman@hhchealth.org
Antonio Fernandez, MD
Houston Methodist Research Institute
Houston, Texas, 77030
Digant Jariwala, djariwala@houstonmethodist.org
Janice Zimmerman, MD
Baptist Memorial Hospital, Baptist Clinical Research Institute
Memphis, Tennessee, 38120
Mildred Jenkins, Mildred.Jenkins@BMHCC.org
Patricia Hopkins
University Nebraska Medical Center
Omaha, Nebraska, 68198
Lace D Sindt, BS, lace.sindt@unmc.edu
James N Sullivan, MD
Denmark2 sites
Aalborg University Hospital
Aalborg
University Hospital, Rigshospitalet, Blegdamsvej 9
Copenhagen
About this study
Official title: XePOHCAS - Xenon by Inhalation for Post Out of Hospital Cardiac Arrest Syndrome
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).
Read the 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).
- Conditions
- Post-Cardiac Arrest Syndrome
- Being tested
- Xenon
- Keywords
- ischemic-reperfusion injury, out of hospital cardiac arrest
- Medical subject headings
- Post-Cardiac Arrest Syndrome, Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XenonCombination product
Also called XENEX
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 group | Role | What they receive |
|---|---|---|
| TH/TTM | No intervention | Protocol-directed standard of care (including TH/TTM) dictated by the 2015 guidelines for Post-Cardiac Arrest Care from the American Heart Association and the European Resuscitation Council. Mechanical Ventilation delivered by individual site-sanctioned ventilator. |
| TH/TTM plus Xenon | Active comparator | 50% xenon gas in addition to standard of care, including therapeutic hypothermia/targeted temperature management (TH/TTM). Receives: Combination Product: Xenon |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional outcome: degree of functional independence measured using a modified Rankin Scale (mRS)
The degree of functional independence will be measured using a modified Rankin Scale (mRS)
Measured: 30 days after the cardiac arrest
Secondary outcomes (1)
survival: number of survivors
The number of survivors will be measured
Measured: 30 days after the cardiac arrest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study startMar 2026 (estimated)
- Primary completionApr 2029 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post-Cardiac Arrest SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,436 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Invero Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steffen Stuerzebecher, M.D., Study director, CMO Invero Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03176186
- Sponsor's protocol ID
- XePOHCAS Ph III
- Acronym
- XePOHCAS
- Status last verified
- Mar 2025
- First submitted
- 5 Dec 2016
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Authorized representatives of the SITE OF STUDY CONDUCT or other associated health care providers as authorized.
Publications
Laitio R, Hynninen M, Arola O, Virtanen S, Parkkola R, Saunavaara J, Roine RO, Gronlund J, Ylikoski E, Wennervirta J, Backlund M, Silvasti P, Nukarinen E, Tiainen M, Saraste A, Pietila M, Airaksinen J, Valanne L, Martola J, Silvennoinen H, Scheinin H, Harjola VP, Niiranen J, Korpi K, Varpula M, Inkinen O, Olkkola KT, Maze M, Vahlberg T, Laitio T. Effect of Inhaled Xenon on Cerebral White Matter Damage in Comatose Survivors of Out-of-Hospital Cardiac Arrest: A Randomized Clinical Trial. JAMA. 2016 Mar 15;315(11):1120-8. doi: 10.1001/jama.2016.1933.
PubMed 26978207Magliocca A, Fries M. Inhaled gases as novel neuroprotective therapies in the postcardiac arrest period. Curr Opin Crit Care. 2021 Jun 1;27(3):255-260. doi: 10.1097/MCC.0000000000000820.
PubMed 33769417
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- XePOHCAS - Xenon by Inhalation for Post Out of Hospital Cardiac Arrest Syndrome
- ClinicalTrials.gov ID
- NCT03176186
- Acronym / sponsor ID
- XePOHCAS / XePOHCAS Ph III
- Conditions
- Post-Cardiac Arrest Syndrome
- Keywords
- ischemic-reperfusion injury, out of hospital cardiac arrest
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,436 participants (estimated)
- Lead sponsor
- Invero Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2026 (estimated)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 5 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TH/TTM | No intervention | –Protocol-directed standard of care (including TH/TTM) dictated by the 2015 guidelines for Post-Cardiac Arrest Care from the American Heart Association and the European Resuscitation Council. Mechanical Ventilation delivered by individual site-sanctioned ventilator. |
| TH/TTM plus Xenon | Active comparator | Combination Product: Xenon50% xenon gas in addition to standard of care, including therapeutic hypothermia/targeted temperature management (TH/TTM). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XenonAlso: XENEX50% 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. | Combination product | TH/TTM plus Xenon |
Primary outcome
functional outcome: degree of functional independence measured using a modified Rankin Scale (mRS)
Time frame: 30 days after the cardiac arrest
The degree of functional independence will be measured using a modified Rankin Scale (mRS)
1 secondary outcome
survival: number of survivors
Time frame: 30 days after the cardiac arrest
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Background: PubMed 26978207Laitio R, Hynninen M, Arola O, Virtanen S, Parkkola R, Saunavaara J, Roine RO, Gronlund J, Ylikoski E, Wennervirta J, Backlund M, Silvasti P, Nukarinen E, Tiainen M, Saraste A, Pietila M, Airaksinen J, Valanne L, Martola J, Silvennoinen H, Scheinin H, Harjola VP, Niiranen J, Korpi K, Varpula M, Inkinen O, Olkkola KT, Maze M, Vahlberg T, Laitio T. Effect of Inhaled Xenon on Cerebral White Matter Damage in Comatose Survivors of Out-of-Hospital Cardiac Arrest: A Randomized Clinical Trial. JAMA. 2016 Mar 15;315(11):1120-8. doi: 10.1001/jama.2016.1933.
- Derived from this study: PubMed 33769417Magliocca A, Fries M. Inhaled gases as novel neuroprotective therapies in the postcardiac arrest period. Curr Opin Crit Care. 2021 Jun 1;27(3):255-260. doi: 10.1097/MCC.0000000000000820.
- Individual participant dataSharing planned: Yes. Authorized representatives of the SITE OF STUDY CONDUCT or other associated health care providers as authorized.
Related trials for Post-Cardiac Arrest Syndrome
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
Recruiting
Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury
RecruitingObservational study
Analysis of Life-threatening ARrhythMias After Acute Coronary Syndrome
Acute Coronary Syndromes (ACS), Ventricular Tachycardia (VT)
Recruiting
Cerebral Oximetry in Management of Post Cardiac Arrest
Post-Cardiac Arrest Syndrome, Post Cardiac Arrest Brain Injury
Active, not recruitingObservational study
Multiomics Profiling of CSF in Cardiac Arrest Survivors
Cardiac Arrest (CA), Hypoxic-Ischemic Brain Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Steffen Stuerzebecher, M.D. study director
CMO Invero Pharma
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Xenon in people with Post-Cardiac Arrest Syndrome, run by Invero Pharma, Inc. at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trial Support at Invero Pharma ((862) 800-7788 ext. 801, dstefanelli@inveropharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional outcome: degree of functional independence measured using a modified Rankin Scale (mRS) (time frame: 30 days after the cardiac arrest). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03176186, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.