Xenon for Neuroprotection During Post-Cardiac Arrest Syndrome in Comatose Survivors of an Out of Hospital Cardiac Arrest
NCT ID: NCT03176186
Last Updated: 2025-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
1436 participants
INTERVENTIONAL
2026-03-31
2030-05-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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TH/TTM
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.
No interventions assigned to this group
TH/TTM plus Xenon
50% xenon gas in addition to standard of care, including therapeutic hypothermia/targeted temperature management (TH/TTM).
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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)
18 Years
80 Years
ALL
No
Sponsors
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Invero Pharma, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Steffen Stuerzebecher, M.D.
Role: STUDY_DIRECTOR
CMO Invero Pharma
Locations
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Hartford Hospital
Hartford, Connecticut, United States
University of Florida
Gainesville, Florida, United States
Memorial Hospital at Gulfport
Gulfport, Mississippi, United States
University Nebraska Medical Center
Omaha, Nebraska, United States
University at Buffalo
Buffalo, New York, United States
Wexner Medical Center, Ohio State University
Columbus, Ohio, United States
Baptist Memorial Hospital, Baptist Clinical Research Institute
Memphis, Tennessee, United States
Houston Methodist Research Institute
Houston, Texas, United States
Aalborg University Hospital
Aalborg, , Denmark
University Hospital, Rigshospitalet, Blegdamsvej 9
Copenhagen, , Denmark
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Magliocca 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.
Related Links
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Phase 2 RCT that forms the basis for this clinical trial
Other Identifiers
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XePOHCAS Ph III
Identifier Type: -
Identifier Source: org_study_id
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