About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age at least 18 years but less than or equal to 80 years
Presumed cardiac cause of arrest
Sustained (>20 minutes) spontaneous circulation upon arrival in the emergency department
No response to verbal commands on arrival to emergency department and prior to randomization (Glasgow Coma Scale score of <8)
Disqualifiers
Written do not attempt resuscitation reported to providers before randomization
Traumatic etiology of arrest, defined as concomitant blunt, penetrating, or burn-related injury, or uncontrolled bleeding or exsanguination
Suspected or known stroke or intracranial hemorrhage
Unwitnessed cardiac arrest
Trial design
Parallel
Treatments tested in this trial
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.
Treatment groups
Trial outcomes
Primary outcomes
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)
Secondary outcomes
survival: number of survivors
The number of survivors will be measured
Sponsors and contacts
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