XePOHCAS is a prospective, randomized, multicenter, interventional trial in adult subjects with OHCA during which the standard-of-care for post–cardiac arrest intensive care (including TTM) is compared to the same treatment with the addition of 50% xenon by inhalation.

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 standard-of-care post-cardiac arrest intensive care (including TTM) plus xenon by inhalation - XePOHCAS

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002514-32-DE

Enrollment

1436

Registered

2018-07-24

Start date

2019-04-15

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-cardiac arrest syndrome MedDRA version: 20.0 Level: PT Classification code 10078202 Term: Post cardiac arrest syndrome System Organ Class: 10029205 - Nervous system disorders

Interventions

Product Name: XENEX™ (Xenon gas for inhalation) Pharmaceutical Form: Medicinal gas, compressed INN or Proposed INN: Xenon Current Sponsor code: XENEX™

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age at least 18 but less than or equal to 80 years. 2. Presumed cardiac cause of arrest. 3. ROSC within 30 minutes and sustained for >20 minutes. 4. No response to verbal commands prior to randomization (Glasgow Coma Scale score of =65 years) yes F.1.3.1 Number of subjects for this age range 500

Exclusion criteria

Exclusion criteria: 1. A written do not attempt resuscitation is reported to providers before randomization. 2. There is a traumatic etiology of arrest, defined as concomitant blunt, penetrating, or burn-related injury, or uncontrolled bleeding or exsanguination. 3. The subject is suspected or known to be having a stroke, intracranial hemorrhage or raised intracranial pressure. 4. The cardiac arrest was unwitnessed. 5. The subject has a no-flow (cardiac arrest to initiation of chest compressions) time of greater than 10 minutes. 6. The interval from the cardiac arrest to initiation of TTM is greater than 5 hours. 7. The interval from the cardiac arrest to initiation of xenon treatment is greater than 5 hours. 8. The subject is experiencing hypothermia (less than 30°C core temperature). 9. The subject was bed-bound prior to cardiac arrest. 10. The subject experienced unconsciousness before cardiac arrest (cerebral trauma, spontaneous cerebral hemorrhage, intoxication etc.). 11. The subject suffers from coagulopathy, not including intentional therapeutically-induced anticoagulation. 12. The subject has a systolic arterial pressure less than 80 mmHg or a mean arterial pressure less than 60 mmHg lasting for more than 30 minutes after ROSC or requires a non-pharmacologic cardiac assist device to maintain hemodynamic stability. 13. The subject is known to be pregnant or breastfeeding. 14. The subject has received an investigational drug, device, or biologic product within 30 days. 15. The subject is known to be in the terminal phase of a chronic illness. 16. The subject has experienced hypoxemia (saturation of arterial oxygen [SaO2 ] or oxygen saturation determined by periphery oximetry [SpO2] less than 85%) for more than 30 minutes after ROSC. 17. The subject is unable to maintain a SaO2 or SpO2 of =90% while on an FiO2 of 0.5. 18. The subject requires extra-corporal membrane oxygenation for gas exchange and/or perfusion. 19. The subject is known to have any other clinically significant laboratory abnormality, medical condition (such as decompensated liver disease or severe chronic obstructive pulmonary disease), or social circumstance that, in the investigator’s opinion, makes it inappropriate for the subject to participate in this clinical trial. 20. It is logistically impossible to provide intervention. 21. The subject is known to have a moderate or severe disability precluding their independent performance of complex tasks (e.g., shopping, cleaning, cooking) before the OHCA. 22. The subject has a known history of malignant hyperthermia.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to evaluate, on Day 30 and Day 90 post OHCA, whether there is a difference in functional outcome in comatose subjects who achieved restoration of spontaneous circulation (ROSC) within 30 minutes after OHCA and were treated during TTM with xenon (50% ±2%) + oxygen (50% ±3%) vs. those receiving similar oxygen (50% ±3%) treatment during TTM, but without supplementary xenon during TTM.; Secondary Objective: - To evaluate whether there is a difference in percent of subjects surviving to Day 30 and Day 90 post-OHCA following treatment with xenon (50%±2%) + oxygen (50%±3%) during TTM, compared to treatment with oxygen(50%±3%) treatment (without xenon) during TTM. - To compare time to achieve target body temperature in OHCA subjects treated with xenon (50%±2%) + oxygen (50%±3%) during TTM, compared to similar oxygen (50%±3%) treatment (without xenon) during TTM. - To test for, estimate, and adjust for multivariable effects of selected covariates on Day 30 and Day 90 functional outcome and proportionate survival in subjects treated with xenon (50%±2%) + oxygen (50%±3%) during TTM, compared to similar oxygen (50%±3%) treatment (without xenon) during TTM. - To conduct sensitivity analyses to investigate the effects of subject dropout on the magnitude of estimates of treatment effects on the primary endpoint. - To evaluate the safety and tolerability of xenon therapy in the treatment of OHCA. ;Primary end point(s): For both the interim and the final analyses, the primary efficacy endpoint will be the binomial proportion of subjects with good functional outcome on Day 30 and Day 90 post-OHCA. Good functional outcome will be defined as an mRS =2.;Timepoint(s) of evaluation of this end point: At 30 days and 90 days post-arrest.	—

Measure

Time frame

Main Objective: The primary objective is to evaluate, on Day 30 and Day 90 post OHCA, whether there is a difference in functional outcome in comatose subjects who achieved restoration of spontaneous circulation (ROSC) within 30 minutes after OHCA and were treated during TTM with xenon (50% ±2%) + oxygen (50% ±3%) vs. those receiving similar oxygen (50% ±3%) treatment during TTM, but without supplementary xenon during TTM.; Secondary Objective: - To evaluate whether there is a difference in percent of subjects surviving to Day 30 and Day 90 post-OHCA following treatment with xenon (50%±2%) + oxygen (50%±3%) during TTM, compared to treatment with oxygen(50%±3%) treatment (without xenon) during TTM. - To compare time to achieve target body temperature in OHCA subjects treated with xenon (50%±2%) + oxygen (50%±3%) during TTM, compared to similar oxygen (50%±3%) treatment (without xenon) during TTM. - To test for, estimate, and adjust for multivariable effects of selected covariates on Day 30 and Day 90 functional outcome and proportionate survival in subjects treated with xenon (50%±2%) + oxygen (50%±3%) during TTM, compared to similar oxygen (50%±3%) treatment (without xenon) during TTM. - To conduct sensitivity analyses to investigate the effects of subject dropout on the magnitude of estimates of treatment effects on the primary endpoint. - To evaluate the safety and tolerability of xenon therapy in the treatment of OHCA. ;Primary end point(s): For both the interim and the final analyses, the primary efficacy endpoint will be the binomial proportion of subjects with good functional outcome on Day 30 and Day 90 post-OHCA. Good functional outcome will be defined as an mRS =2.;Timepoint(s) of evaluation of this end point: At 30 days and 90 days post-arrest.

—

Secondary

Measure	Time frame
Secondary end point(s): - The binomial proportion of subjects surviving to Day 30 and Day 90 following treatment with xenon (50% ±2%) + oxygen (50% ±3%) during TTM or a similar oxygen (50% ±3%) treatment (without xenon) during TTM. - Body temperature, during the Intervention Phase, in OHCA subjects treated with xenon (50% ±2%) + oxygen (50% ±3%) during TTM or with a similar oxygen (50% ±3%) treatment (without xenon) during TTM. - Covariates, including site, treatment arm, mode and rate of TTM, initial rhythm, time to ROSC, age, gender, and presence of shock, that may affect Day 30 and Day 90 functional outcome and proportionate survival in subjects treated with xenon (50% ±2%) + oxygen (50% ±3%) during TTM or with a similar oxygen (50% ±3%) treatment (without xenon) during TTM. - The number and timing of subjects who do not complete the study through the evaluation phase, unless the reason for discontinuation is death. ;Timepoint(s) of evaluation of this end point: At 30 days and 90 days post-arrest.	—

Measure

Time frame

Secondary end point(s): - The binomial proportion of subjects surviving to Day 30 and Day 90 following treatment with xenon (50% ±2%) + oxygen (50% ±3%) during TTM or a similar oxygen (50% ±3%) treatment (without xenon) during TTM. - Body temperature, during the Intervention Phase, in OHCA subjects treated with xenon (50% ±2%) + oxygen (50% ±3%) during TTM or with a similar oxygen (50% ±3%) treatment (without xenon) during TTM. - Covariates, including site, treatment arm, mode and rate of TTM, initial rhythm, time to ROSC, age, gender, and presence of shock, that may affect Day 30 and Day 90 functional outcome and proportionate survival in subjects treated with xenon (50% ±2%) + oxygen (50% ±3%) during TTM or with a similar oxygen (50% ±3%) treatment (without xenon) during TTM. - The number and timing of subjects who do not complete the study through the evaluation phase, unless the reason for discontinuation is death. ;Timepoint(s) of evaluation of this end point: At 30 days and 90 days post-arrest.

—

Countries

Austria, Canada, Denmark, France, Germany, Poland, Spain, United Kingdom, United States

Contacts

Public ContactMervyn Maze

NeuroproteXeon, Inc.

mervyn.maze.cal@neuroprotexeon.com+17163327200

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026