Xenon for Neuroprotection During Post-Cardiac Arrest Syndrome in Comatose Survivors of an Out of Hospital Cardiac Arrest
Part of paid clinical trials in Hartford, Connecticut.
- Sponsor
- Invero Pharma, Inc.
- Study ID
- NCT03176186
- Phase
- PHASE3
- Status
- Not Yet Recruiting
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Conditions
- Post-Cardiac Arrest Syndrome
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- Xenon — COMBINATION_PRODUCT50% 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 Details
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).
Key Dates
- Start date
- Mar 31, 2026
- Status verified
- Mar 2025
- Primary completion
- Apr 30, 2029
- Completion
- May 31, 2030
Study Design
- Enrollment
- 1,436 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- No Intervention: TH/TTMProtocol-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.
- Active Comparator: TH/TTM plus Xenon50% xenon gas in addition to standard of care, including therapeutic hypothermia/targeted temperature management (TH/TTM).
Primary Outcome Measure
functional outcome: degree of functional independence measured using a modified Rankin Scale (mRS) [ Time Frame: 30 days after the cardiac arrest ]
Central Contacts
- Clinical Trial Support at Invero Pharma(862) 800-7788
- Regulatory Affairs at Invero Pharma(862) 800-7788
Locations (8)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Hartford Hospital | Hartford | Connecticut | 06102 | William Roman Antonio Fernandez, MD (PRINCIPAL_INVESTIGATOR) |
| University of Florida | Gainesville | Florida | 32611 | - |
| Memorial Hospital at Gulfport | Gulfport | Mississippi | 39503 | Joseph R. Bosarge, M.D. (PRINCIPAL_INVESTIGATOR) |
| University Nebraska Medical Center | Omaha | Nebraska | 68198 | Lace D Sindt, BS James N Sullivan, MD (PRINCIPAL_INVESTIGATOR) |
| University at Buffalo | Buffalo | New York | 14203 | Vijay Iyer, MD (PRINCIPAL_INVESTIGATOR) |
| Wexner Medical Center, Ohio State University | Columbus | Ohio | 43210 | Uribe Alberto, MD (PRINCIPAL_INVESTIGATOR) |
| Baptist Memorial Hospital, Baptist Clinical Research Institute | Memphis | Tennessee | 38120 | Mildred Jenkins Patricia Hopkins (PRINCIPAL_INVESTIGATOR) |
| Houston Methodist Research Institute | Houston | Texas | 77030 | Digant Jariwala Janice Zimmerman, MD (PRINCIPAL_INVESTIGATOR) |