Xenon for Out-of-Hospital Cardiac Arrest

(XePOHCAS Trial)

Not yet recruiting at 9 trial locations

Overseen By Regulatory Affairs at Invero Pharma

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Invero Pharma, Inc.

Disqualifiers: Stroke, Intracranial hemorrhage, Pregnancy, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate post-cardiac arrest period

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for individuals who have experienced a cardiac arrest outside of a hospital. It seeks to determine if inhaling xenon gas, combined with the usual cooling therapy (targeted temperature management), improves recovery compared to using cooling therapy alone. The trial may suit adults who have had a cardiac arrest believed to be heart-related, regained circulation before hospital arrival, but are still unresponsive to verbal commands upon arrival. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that xenon gas is usually safe for people. One study found that participants who inhaled xenon gas and held their breath for short periods did not experience severe side effects, and they considered the process safe and manageable.

In medical imaging, xenon has not caused any serious problems, indicating its safety for the body. However, this trial tests xenon in a new way, specifically for patients who have had a cardiac arrest.

Since this trial is in a late stage, earlier research has found xenon to be quite safe. Nonetheless, discussing any concerns and asking questions before joining a trial is always advisable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for cardiac arrest, which typically include therapeutic hypothermia and targeted temperature management, the use of xenon gas offers a novel approach. Xenon is unique because it's an inert gas that can protect brain cells from damage during oxygen deprivation, which often happens during cardiac arrest. Researchers are excited about xenon because it could enhance recovery by reducing neurological damage more effectively than existing treatments. This approach might provide a new way to improve outcomes for patients who experience cardiac arrest outside of a hospital setting.

What evidence suggests that xenon might be an effective treatment for cardiac arrest?

Research shows that xenon gas might help treat cardiac arrest occurring outside hospitals. In this trial, one group of participants will receive xenon gas alongside standard care, which includes therapeutic hypothermia/targeted temperature management (TH/TTM). Xenon may protect brain cells from damage after cardiac arrest by affecting specific brain areas involved in cell death. Studies have found that using xenon with standard treatments can lessen brain injury. Thus, adding xenon to current care methods might improve recovery for patients experiencing cardiac arrest outside hospitals. ^{1 4 6 7 8}

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

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

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?

Group I: TH/TTM plus Xenon Active Control 1 Intervention

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

Group II: TH/TTM Active Control 1 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.

Who Is Running the Clinical Trial?

Invero Pharma, Inc.

Lead Sponsor

Trials

1

Recruited

1,400+

NeuroproteXeon, Inc.

Lead Sponsor

Trials

1

Recruited

1,400+

NeuroproteXeon, Inc.

Lead Sponsor

Trials

1

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10291299/

Functional xenon-129 magnetic resonance imaging ... A measure of regional gas exchange on HP 129 Xe MRI was able to detect apparent improvements in IPF patients treated with antifibrotic medication after 1 year.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3244666/

Safety and Tolerability of Hyperpolarized 129Xe MR ... Graphs show mean change in vital signs after xenon dose administration relative to baseline as a function of time. Data were acquired after inhaling the xenon ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02272049

Study Details | Use of Hyperpolarized Xenon Gas for Lung ... The goal of this study is to evaluate the usefulness of hyperpolarized (HP) 129Xe (xenon) gas MRI for regional assessment of lung function in a normal ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S266644102400030X

A standardized MRI phantom for dissolved phase 129Xe MRI This work introduces a new phantom concept that reproduces clinical MRI. Suitable phantom materials are identified and characterized via hp 129 Xe NMR and MRI.

5. pubs.rsna.org pubs.rsna.org/doi/10.1148/ryct.240562

Hyperpolarized 129 Xe MRI and Spectroscopy This review aims to summarize established and emerging quantitative measurements derived from 129Xe MRI and MR spectroscopy (MRS) and illustrate ...

6. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/radiol.220069

Lung Abnormalities Detected with Hyperpolarized 129 Xe ... Hyperpolarized xenon 129 MRI and total lung diffusion capacity for carbon monoxide demonstrate significantly impaired gas transfer in nonhospitalized ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02316379

Use of Hyperpolarized 129Xe MR Lung Imaging in Adults ... The goal of this study is to evaluate the usefulness of hyperpolarized (HP) 129Xe (xenon) gas MRI for regional assessment of lung function in a normal ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7933823/

In vivo methods and applications of xenon-129 magnetic ... This article reviews the methods and applications of in vivo 129 Xe MR in humans, with a focus on the physics of polarisation by optical pumping.