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)
functional outcome: degree of functional independence measured using a modified Rankin Scale (mRS) — 30 days after the cardiac arrest The degree of functional independence will be measured using a modified Rankin Scale (mRS)
Trial sites (10)
Facility
City
Region
Status
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.
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