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NCT03176186 | NOT YET RECRUITING | Post-Cardiac Arrest Syndrome

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

Indeed Pharma, Inc.

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).

Condition or disease

Post-Cardiac Arrest Syndrome

Intervention/treatment

Xenon

Phase

PHASE3

Detailed Description:

XePOHCAS: 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).

Study Type : INTERVENTIONAL
Estimated Enrollment : 1436 participants
Masking : SINGLE
Primary Purpose : TREATMENT
Official Title : XePOHCAS - Xenon by Inhalation for Post Out of Hospital Cardiac Arrest Syndrome
Actual Study Start Date : 2026-03
Estimated Primary Completion Date : 2029-04
Estimated Study Completion Date : 2030-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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)
Xenon for Neuroprotection During Post-Cardiac Arrest Syndrome in Comatose Survivors of an Out of Hospital Cardiac Arrest

Location Details

NCT03176186

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Connecticut

Hartford Hospital

Hartford, Connecticut, United States, 06102

Not yet recruiting

United States, Florida

University of Florida

Gainesville, Florida, United States, 32611

Not yet recruiting

United States, Mississippi

Memorial Hospital at Gulfport

Gulfport, Mississippi, United States, 39503

Not yet recruiting

United States, Nebraska

University Nebraska Medical Center

Omaha, Nebraska, United States, 68198

Not yet recruiting

United States, New York

University at Buffalo

Buffalo, New York, United States, 14203

Not yet recruiting

United States, Ohio

Wexner Medical Center, Ohio State University

Columbus, Ohio, United States, 43210

Not yet recruiting

United States, Tennessee

Baptist Memorial Hospital, Baptist Clinical Research Institute

Memphis, Tennessee, United States, 38120

Not yet recruiting

United States, Texas

Houston Methodist Research Institute

Houston, Texas, United States, 77030

Not yet recruiting

Denmark,

Aalborg University Hospital

Aalborg, Denmark,

Not yet recruiting

Denmark,

University Hospital, Rigshospitalet, Blegdamsvej 9

Copenhagen, Denmark,