NCT03176186

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

XePOHCAS - Xenon by Inhalation for Post Out of Hospital Cardiac Arrest Syndrome

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,436 (estimated)
• Sponsor: Invero Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Detailed 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 sustained restoration of spontaneous circulation (ROSC) within 30 minutes after out-of-hospital cardiac arrest (OHCA).

Conditions

• Post-Cardiac Arrest Syndrome

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Xenon	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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2029-04-01
• Completion: 2030-05-01
• First posted: 2017-06-05
• Last updated: 2025-04-03

Locations

10 sites across 2 countries: United States, Denmark

Regulatory

• FDA-regulated drug study
• FDA-regulated device study