XePOHCAS - Xenon by Inhalation for Post Out of Hospital Cardiac Arrest Syndrome
Invero Pharma, Inc.
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).
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 susta…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- 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,…
Interventions
- Combination ProductXenon
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.
Locations (10)
- Hartford HospitalHartford, Connecticut
- University of FloridaGainesville, Florida
- Memorial Hospital at GulfportGulfport, Mississippi
- University Nebraska Medical CenterOmaha, Nebraska
- University at BuffaloBuffalo, New York
- Wexner Medical Center, Ohio State UniversityColumbus, Ohio