Xenon for Neuroprotection During Post-Cardiac Arrest Syndrome in Comatose Survivors of an Out of Hospital Cardiac Arrest

NCT03176186
clinicaltrials.gov
Phase
Phase 3
clinicaltrials.gov
Recruitment status
Not yet recruiting
clinicaltrials.gov
Participants
1,436
clinicaltrials.gov
Lead sponsor
Invero Pharma, Inc.
clinicaltrials.gov
Start date
2026-03-01
clinicaltrials.gov
Number of sites
10
clinicaltrials.gov

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).
clinicaltrials.gov
Acronym
XePOHCAS
clinicaltrials.gov
Short title
Xenon for Neuroprotection During Post-Cardiac Arrest Syndrome in Comatose Survivors of an Out of Hospital Cardiac Arrest
clinicaltrials.gov
Official title
XePOHCAS - Xenon by Inhalation for Post Out of Hospital Cardiac Arrest Syndrome
clinicaltrials.gov

Control arm
Active comparator
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Not yet recruiting
clinicaltrials.gov
Phase
Phase 3
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2030-05-01
clinicaltrials.gov
First posted
2017-06-05
clinicaltrials.gov
Registry last updated
2025-04-03
clinicaltrials.gov
Primary completion date
2029-04-01
clinicaltrials.gov
Start date
2026-03-01
clinicaltrials.gov

Participants
1,436
clinicaltrials.gov
Participant count basis
Estimated
clinicaltrials.gov
Planned participants
1,436
clinicaltrials.gov
Protocol amendments
2
clinicaltrials.gov
Number of sites
10
clinicaltrials.gov

Data monitoring committee
Yes
clinicaltrials.gov
Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
Invero Pharma, Inc.
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT03176186
clinicaltrials.gov
ClinicalTrials.gov ID
NCT03176186
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Single masking
Masked roles
Outcome assessors
Sources for study design
clinicaltrials.gov

  1. functional outcome: degree of functional independence measured using a modified Rankin Scale (mRS)

    Timeframe: 30 days after the cardiac arrest

    The degree of functional independence will be measured using a modified Rankin Scale (mRS)

  1. survival: number of survivors

    Timeframe: 30 days after the cardiac arrest

    The number of survivors will be measured

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
80 Years
Healthy volunteers
No

  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

  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)
Sources for eligibility
clinicaltrials.gov

  • Hartford HospitalHartford, United States
  • University of FloridaGainesville, United States
  • Memorial Hospital at GulfportGulfport, United States
  • University Nebraska Medical CenterOmaha, United States
  • University at BuffaloBuffalo, United States
  • Wexner Medical Center, Ohio State UniversityColumbus, United States
  • Baptist Memorial Hospital, Baptist Clinical Research InstituteMemphis, United States
  • Houston Methodist Research InstituteHouston, United States
  • Aalborg University HospitalAalborg, Denmark
  • University Hospital, Rigshospitalet, Blegdamsvej 9Copenhagen, Denmark
Sources for sites
clinicaltrials.gov

Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)