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).
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,436
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.
Hartford Hospital
Hartford, Connecticut, United States
University of Florida
Gainesville, Florida, United States
Memorial Hospital at Gulfport
Gulfport, Mississippi, United States
functional outcome: degree of functional independence measured using a modified Rankin Scale (mRS)
The degree of functional independence will be measured using a modified Rankin Scale (mRS)
Time frame: 30 days after the cardiac arrest
survival: number of survivors
The number of survivors will be measured
Time frame: 30 days after the cardiac arrest
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University Nebraska Medical Center
Omaha, Nebraska, United States
University at Buffalo
Buffalo, New York, United States
Wexner Medical Center, Ohio State University
Columbus, Ohio, United States
Baptist Memorial Hospital, Baptist Clinical Research Institute
Memphis, Tennessee, United States
Houston Methodist Research Institute
Houston, Texas, United States
Aalborg University Hospital
Aalborg, Denmark
University Hospital, Rigshospitalet, Blegdamsvej 9
Copenhagen, Denmark