Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Intravenous vs. Intraosseous Vascular Access During Out-of-Hospital Cardiac Arrest – A Randomized Clinical Trial

This research study, called a Phase II trial, is investigating the best way to deliver emergency medicines, adrenaline (epinephrine) and amiodarone, to people who have had a sudden heart stop outside of hospital. When someone's heart stops, doctors need to give these medicines quickly. This study is comparing two ways to give these medicines: putting a needle into a vein (intravenous) or putting a needle directly into the bone (intraosseous). The main goal is to see which method helps more people get their heart beating again strongly and steadily for at least 20 minutes, which doctors call 'sustained return of spontaneous circulation' (ROSC). They will also look at how well people are doing 30 days later, including their survival and brain function.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Præhospitalet

Enrolment target

1,470

Start

04 Jul 2022

Out-of-hospital cardiac arrest (OHCA)

What is this study about?

This research study is about finding the best way to help people who have a sudden heart stop outside of a hospital setting. This is often called an 'out-of-hospital cardiac arrest'. When someone's heart suddenly stops beating effectively, it's a medical emergency, and paramedics or doctors need to act very quickly to try and restart the heart and get blood flowing again.

Two treatments often used in these situations are adrenaline (also known as epinephrine) and amiodarone. These medicines help to stimulate the heart and control irregular heart rhythms. The study is comparing two different ways to give these important medicines. One way is to put a needle into a vein, usually in the arm (called 'intravenous access'). The other way is to put a needle directly into the bone, often in the leg (called 'intraosseous access'). Both methods are used in emergency situations, but doctors want to know if one is more effective than the other in helping people recover.

The main thing the researchers are looking for is whether one method leads to more people getting their heart beating on its own again, and staying that way for at least 20 minutes. This is called 'sustained return of spontaneous circulation' (ROSC). They will also be checking on people 30 days later to see how many survive and how well they are doing, especially how their brain function has been affected. This study is important because finding a better way to give these emergency medicines could save more lives and improve recovery for people who have a sudden heart stop.

Key takeaways

The study compares two ways to give emergency heart medicines: into a vein or into the bone.
It focuses on people who have a sudden heart stop outside of hospital.
The main goal is to see which method helps more people get their heart beating again and stay that way.
Researchers will also check on survival and brain function 30 days later.
This is a Phase II study, looking for the best treatment approach in emergencies.
Participants must be 18 years or older, both men and women included.

Who may be eligible?

To be considered for this study, individuals must be adults, aged 18 years or older. There is no upper age limit for taking part.

This study includes both men and women, regardless of their sex. The focus is specifically on people who experience an out-of-hospital cardiac arrest.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Did you experience a sudden heart stop (cardiac arrest) outside of a hospital?
Were emergency services called to help you?
Did you receive treatments like adrenaline or amiodarone during the emergency?

Answer every question to see your result.

What does participation involve?

If you are involved in this study, it means you would have experienced a sudden heart stop outside of hospital and received emergency care. The study looks at the way emergency medicines (adrenaline and amiodarone) are given to patients in this critical situation, either through a vein or directly into the bone. You wouldn't choose which method is used as it would be decided as part of the study process during the emergency – this is done randomly, like flipping a coin, to ensure fairness and good research.

After the initial emergency care, if you recover, doctors will monitor your condition clinically. The main assessment for the study will be whether your heart starts beating on its own and stays that way for at least 20 minutes. Later, if you survive, there will be a follow-up assessment about 30 days after the event to check on your health and how well you are doing, especially in terms of your brain function. This assessment would likely involve a short conversation or examination by a healthcare professional. The total duration of the study's impact on you would be up to this 30-day follow-up.

Potential risks and benefits

Taking part in this study happens during a life-threatening emergency, so you wouldn't be able to give your consent beforehand. The potential benefit is that the method chosen for you for giving medication might be more effective in helping your heart restart and improving your recovery. However, there are no guarantees, and both methods have known emergency uses and some potential risks, such as infection or damage at the needle site, though these are rare in emergencies. The purpose of this study is to determine which approach might offer the best chance of survival and recovery for future patients. You, or your legal representative, would have the right to withdraw from the study's follow-up at any time without it affecting your ongoing medical care or treatment.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Denmark

Common questions

What does 'out-of-hospital cardiac arrest' mean?

It means your heart suddenly stopped beating effectively while you were outside of a hospital, for example, at home or in a public place.

What are 'intravenous' and 'intraosseous' access?

Intravenous means inserting a needle into a vein, usually in your arm. Intraosseous means inserting a needle directly into the bone, often in your leg, to give medicines quickly.

What is 'sustained return of spontaneous circulation (ROSC)'?

This is when your heart starts beating on its own again, strongly enough to create a pulse, and keeps going for at least 20 minutes without needing chest compressions.

Will I get to choose which treatment method I receive?

No, if you were in this emergency situation, the method would be chosen randomly by the paramedics or doctors as part of the study. You wouldn't be able to make that decision at the time.

What happens after the emergency if I take part?

If you survive, doctors will monitor your recovery, and there will be a follow-up check-up about 30 days later to see how you are doing, including your brain function.