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Compensation: Varies

Number of Visits: Unknown

Duration: Immediate post-cardiac arrest period

1436 Participants Needed

Xenon for Out-of-Hospital Cardiac Arrest
(XePOHCAS Trial)

Recruiting at 9 trial locations

Overseen ByRegulatory Affairs at Invero Pharma

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Invero Pharma, Inc.

Disqualifiers: Stroke, Intracranial hemorrhage, Pregnancy, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval

Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of 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).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What makes the treatment Xenon unique for out-of-hospital cardiac arrest?

Xenon is unique because it acts as a neuroprotectant by inhibiting certain brain receptors, potentially reducing brain damage after cardiac arrest. It is often used in combination with mild therapeutic hypothermia, which together may offer better protection for brain tissue than hypothermia alone.¹ ² ³ ⁴ ⁵

What data supports the effectiveness of the treatment Xenon for out-of-hospital cardiac arrest?

Research shows that xenon, when combined with mild therapeutic hypothermia, can improve functional outcomes in animal models of cardiac arrest. Xenon has neuroprotective properties that may help reduce brain injury after cardiac arrest, although more studies are needed to confirm its effectiveness in humans.¹ ² ³ ⁶ ⁷

Who Is on the Research Team?

Steffen Stuerzebecher, M.D.

Principal Investigator

CMO Invero Pharma

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 who've had a cardiac arrest outside of the hospital, are now in a coma (not responding to voice and with low Glasgow Coma Scale scores), and have stable circulation after being resuscitated. They must be considered suitable for standard post-cardiac arrest care including targeted temperature management.

Inclusion Criteria

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)

Attending decision that patient is eligible for TTM

See 1 more

Exclusion Criteria

Written do not attempt resuscitation reported to providers before randomization

No-flow (cardiac arrest to initiation of cardiopulmonary resuscitation/defibrillation) time of >10 minutes

Interval from arrival at the emergency department to randomization for intervention of >4 hours

See 17 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive xenon by inhalation plus standard-of-care post-cardiac arrest intensive care, including targeted temperature management (TTM)

Immediate post-cardiac arrest period

Follow-up

Participants are monitored for survival and functional outcome using a modified Rankin Scale (mRS)

30 days

What Are the Treatments Tested in This Trial?

Interventions

Xenon

Trial Overview The study compares usual intensive care after cardiac arrest, which includes cooling the body's temperature (TTM), to adding xenon gas inhalation on top of that usual care. It's done at multiple centers where patients are randomly chosen to receive either just TTM or TTM plus xenon.

How Is the Trial Designed?

2Treatment groups

Active Control

Group I: TH/TTM plus XenonActive Control1 Intervention

50% xenon gas in addition to standard of care, including therapeutic hypothermia/targeted temperature management (TH/TTM).

Group II: TH/TTMActive Control1 Intervention

Protocol-directed standard of care (including TH/TTM) dictated by the 2015 guidelines for Post-Cardiac Arrest Care from the American Heart Association and the European Resuscitation Council. Mechanical Ventilation delivered by individual site-sanctioned ventilator.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Invero Pharma, Inc.

Lead Sponsor

Trials

Recruited

1,400+

NeuroproteXeon, Inc.

Lead Sponsor

Trials

Recruited

1,400+

NeuroproteXeon, Inc.

Lead Sponsor

Trials

Recruited

1,400+

Published Research Related to This Trial

Hyperpolarized 129Xe MRI (HypX-MRI) shows great promise as a new diagnostic tool, enhancing the detectability of lung structures and potentially allowing for better imaging of lipid-rich tissues, which has been challenging with traditional methods.

This technique could help identify issues like ventilation-perfusion mismatch in pulmonary diseases and may also be used for functional MRI studies of the brain, opening new avenues for understanding lung function and brain perfusion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of hyperpolarized noble gas MRI.Albert, MS., Balamore, D.[2019]

Hyperpolarized 129 Xenon-MRI (HP 129 Xe MRI) is a new imaging technique that can assess both how well air moves in and out of the lungs (ventilation) and how effectively gases are transferred in the lungs.

While most studies have focused on non-cancer lung diseases, HP 129 Xe MRI shows great potential for improving the management and understanding of lung cancer by evaluating these key lung functions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional airway obstruction observed with hyperpolarized 129 Xenon-MRI.Song, EJ., Kelsey, CR., Driehuys, B., et al.[2022]