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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorInvero Pharma, Inc.

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Xenon

    Combination product

    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.

Treatment groups

1,436 Participants
are divided into 2 treatment groups
Group A: TH/TTMNo intervention 0 interventions
Group B: TH/TTM plus XenonActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

survival: number of survivors

The number of survivors will be measured

Time frame
30 days after the cardiac arrest

Other outcomes

Sponsors and contacts

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