AuthorisedTherapeutic exploratory (Phase II)Interventional

CardioPulmonary resuscitation with Argon (CPAr) trial

This research, called the CPAr trial, is studying a new treatment for people who have had a cardiac arrest (when the heart suddenly stops beating). Doctors want to see if breathing a special gas that mixes Argon with Oxygen can help protect the brain and other organs from damage after this serious event. The main goal is to check how well the brain is protected, using a blood test called NSE. They will also look at how well the heart recovers, using another blood test, and check brain scans for some patients. Ultimately, they hope this treatment could help more people survive and have a better quality of life after a cardiac arrest. This is an early stage of research, helping doctors learn if the treatment works and is safe.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Istituto Di Ricerche Farmacologiche Mario Negri

Enrolment target

120

Start

07 Oct 2024

Cardiac arrest

What is this study about?

Imagine your heart suddenly stops pumping blood around your body – that's a cardiac arrest. When this happens, organs like your brain and heart can get damaged because they don't receive enough oxygen. Even after doctors restart your heart, the damage can sometimes continue.

This study, called the CPAr trial, is looking at a new way to try and protect these vital organs during this critical time. Researchers are investigating if a special gas mixture, containing Argon and Oxygen, can help reduce this damage. They believe Argon might have properties that help shield cells from harm, especially in the brain. They want to see if using this gas after a cardiac arrest can lead to better recovery.

The main way they will check if the treatment is working is by looking at a specific chemical in the blood called Neuron Specific Enolase (NSE). Higher levels of NSE can suggest brain damage, so they hope to see lower levels in patients receiving the Argon mixture. They will also check other things like heart health and brain scans for some patients to get a full picture of how the treatment affects the body. This is an important step in finding new ways to help people recover after a cardiac arrest.

Key takeaways

This study evaluates an Argon and Oxygen gas mixture for cardiac arrest.
The goal is to protect the brain and heart from damage.
It's an early-stage study (Phase II) focusing on safety and effectiveness.
Patients would receive the gas soon after cardiac arrest in critical care.
Recovery and health are monitored for up to six months.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be considered for this study, you would need to be an adult, 18 years old or older. The study welcomes both men and women.

The most important condition for being in this study is that you have recently experienced a cardiac arrest and are receiving emergency medical care for it. This study is for patients who are critically ill and require advanced medical treatment in a hospital.

There will be other detailed medical checks to make sure the study is right for you and that taking part is as safe as possible. These checks would be done by the doctors and nurses involved in the study.

Quick self-check

Are you 18 years old or older?
Have you recently experienced a cardiac arrest?
Are you currently receiving critical care in a hospital?
Is your medical team considering all possible treatment options for your care?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you were to take part in this study, the special Argon and Oxygen gas mixture would be given to you as part of your breathing support, usually through a breathing machine, during your critical care. This would happen soon after your cardiac arrest. Doctors and nurses would closely monitor your health around the clock, just as they would for any patient in critical care.

Blood tests would be taken at specific times, especially to measure the NSE levels we mentioned, which helps them see how your brain is doing. They would also take blood to check your heart health and other organ functions. If you remain unconscious, you might also have special brain scans, like an MRI, to get a detailed look at your brain.

After you've left critical care, the study team would follow up on your recovery for up to six months. This would involve checking your overall health and how well you are recovering and functioning in your daily life. The total duration of active treatment and follow-up is around six months.

Potential risks and benefits

Taking part in any medical study has both potential benefits and risks. For this study, the potential benefit is that the Argon/Oxygen mixture might help protect your brain and heart after a cardiac arrest, potentially leading to a better recovery and quality of life. However, because this is an early-stage study, we don't yet know if this treatment will definitely work or if it will be more effective than standard care. There could be unforeseen side effects from the Argon gas, though it is given under strict medical supervision. Your medical team will explain all known risks. Remember, you would always have the right to withdraw from the study at any time, for any reason, without affecting your medical care.

Locations (1)

—
Italy

Common questions

What is a cardiac arrest?

A cardiac arrest is when your heart suddenly stops beating, causing blood flow to the brain and other organs to stop. It's a medical emergency.

What is Argon and why might it help?

Argon is a natural gas. Scientists think it might help protect cells from damage, especially in the brain, after a serious event like a cardiac arrest.

What does 'Phase II' mean for a study?

Phase II means it's an early-stage study. Doctors are looking to see if the treatment works and is safe in a small group of people, before testing it more widely.

Will I or my family know if I am receiving the Argon mixture or just Oxygen?

Because this is a clinical trial, some patients will receive the Argon mixture and others will receive only Oxygen (the standard treatment). For studies like this, often neither the patient nor the medical team knows who is getting which treatment until after the study is over, to ensure fair results (this is called 'blinding').

What is NSE and why is it important?

NSE (Neuron Specific Enolase) is a substance found in the brain. If brain cells are damaged, more NSE can leak into the blood. Measuring NSE helps doctors understand if the brain is being protected.