Xenon for Neuroprotection During Post-Cardiac Arrest Syndrome in Comatose Survivors of an Out of Hospital Cardiac Arrest
XePOHCAS
XePOHCAS - Xenon by Inhalation for Post Out of Hospital Cardiac Arrest Syndrome
1 other identifier
interventional
1,436
2 countries
10
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2026
Typical duration for phase_3
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2016
CompletedFirst Posted
Study publicly available on registry
June 5, 2017
CompletedStudy Start
First participant enrolled
March 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2030
April 3, 2025
March 1, 2025
3.1 years
December 5, 2016
April 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
30 days after the cardiac arrest
Secondary Outcomes (1)
survival: number of survivors
30 days after the cardiac arrest
Study Arms (2)
TH/TTM
NO INTERVENTIONProtocol-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 COMPARATOR50% xenon gas in addition to standard of care, including therapeutic hypothermia/targeted temperature management (TH/TTM).
Interventions
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.
Eligibility Criteria
You 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 may not qualify 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Hartford Hospital
Hartford, Connecticut, 06102, United States
University of Florida
Gainesville, Florida, 32611, United States
Memorial Hospital at Gulfport
Gulfport, Mississippi, 39503, United States
University Nebraska Medical Center
Omaha, Nebraska, 68198, United States
University at Buffalo
Buffalo, New York, 14203, United States
Wexner Medical Center, Ohio State University
Columbus, Ohio, 43210, United States
Baptist Memorial Hospital, Baptist Clinical Research Institute
Memphis, Tennessee, 38120, United States
Houston Methodist Research Institute
Houston, Texas, 77030, United States
Aalborg University Hospital
Aalborg, Denmark
University Hospital, Rigshospitalet, Blegdamsvej 9
Copenhagen, Denmark
Related Publications (2)
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.
PMID: 26978207BACKGROUNDMagliocca 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.
PMID: 33769417DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Steffen Stuerzebecher, M.D.
CMO Invero Pharma
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2016
First Posted
June 5, 2017
Study Start
March 1, 2026
Primary Completion (Estimated)
April 1, 2029
Study Completion (Estimated)
May 1, 2030
Last Updated
April 3, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
Authorized representatives of the SITE OF STUDY CONDUCT or other associated health care providers as authorized.