RecruitingNAINTERVENTIONAL

Early Catheter-directed Treatment of High Risk Pulmonary Embolism

This research study is looking at the best way to treat a very serious type of blood clot in the lungs, called a pulmonary embolism, which can be life-threatening. We are comparing two main approaches. One group of patients will receive the usual care given for this condition. The other group will receive the usual care but also have an additional procedure where a small tube (catheter) is guided to the clot in the lungs to help break it up or remove it. The purpose of this study is to see if adding this catheter-based procedure improves patient outcomes more than standard care alone for people with particularly high-risk blood clots in their lungs.

At a glance

Status

Recruiting

Phase

Sponsor

Leipzig Heart Science gGmbH

Enrolment target

210

Start

27 Dec 2024

Estimated completion

30 Jun 2027

Pulmonary Embolism Acute Massive

What is this study about?

This study is about finding the best treatment for a very serious condition called a 'pulmonary embolism'. This happens when a blood clot, usually from another part of the body, travels to the lungs and blocks blood flow. In severe cases, this can put a lot of strain on your heart and be very dangerous.

Doctors are comparing two ways to help patients with these high-risk blood clots. One way is the standard care that doctors usually provide. The other way involves giving standard care but also using a special procedure. In this procedure, doctors insert a thin, flexible tube called a 'catheter' into a blood vessel and guide it to the clot in the lung. This catheter can then be used to break up the clot or deliver medicines directly to it, aiming to clear the blockage more quickly.

The main goal of this study is to see if adding this catheter procedure to standard care helps patients recover better and reduces the risks associated with this severe type of blood clot, compared to just having standard care alone. By comparing these two approaches, we hope to learn which method gives patients the best chance of a good outcome.

Key takeaways

This study compares two ways to treat severe lung blood clots.
One group gets standard care, the other gets standard care plus a special catheter procedure.
It aims to find out which treatment is more effective for high-risk patients.
Participation involves monitoring and care specific to your assigned treatment group.
You can withdraw from the study at any time without affecting your medical treatment.

Who may be eligible?

This study is looking for adults who are 18 years old or older and have a severe blood clot in their lungs that doctors believe puts them at high risk. This means heart failure signs shown by scans and very low blood pressure or requiring medication to keep blood pressure up, along with other signs that organs aren't getting enough blood flow.

However, there are certain situations where someone wouldn't be able to join the main part of the study. For example, if you have other medical conditions that make a catheter procedure unsafe for you. Also, if you have a high risk of bleeding, have had recent surgery (especially on your brain or spine) or a stroke, or have a brain tumour, you wouldn't be able to take part. If you are pregnant, you also can't join.

It's important to note that if you have contraindications for certain medications but still need the catheter procedure, you might be considered for a separate part of the study, which is like a registry to track outcomes.

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?
Have doctors confirmed you have a high-risk blood clot in your lungs?
Do you not have any major reasons that would make a catheter procedure unsafe for you?
Are you not pregnant?
Have you not had recent intensive surgery or a stroke?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to one of two groups, like flipping a coin. One group will receive the standard care for your condition. The other group will receive the standard care plus the special catheter procedure to treat the blood clot. You will have regular check-ups and tests, such as blood tests and scans, to monitor your health and how the treatment is working. The exact number of visits and assessments will vary depending on your medical needs and recovery. The total duration of your participation will depend on your individual response and follow-up requirements, but the doctors will keep track of your progress over a period of time after your initial treatment.

Potential risks and benefits

Taking part in this study could potentially offer an earlier or more targeted treatment for your severe blood clot, which might lead to a better recovery for some patients. However, like all medical procedures, the catheter treatment carries risks, such as bleeding, infection, or damage to blood vessels. Standard treatments also have their own potential side effects. You will always receive care that your doctors believe is most appropriate for your condition. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (18)

Universitätsklinikum Freiburg
Verified postcode
Bad Krozingen, Germany· Recruiting
Oberlausitzklinikum Bautzen, Medizinische Klinik I
Verified postcode
Bautzen, Germany· Recruiting
Universitätsklinikum Bonn
Verified postcode
Bonn, Germany· Recruiting
Universitätsklinik Düsseldorf, Klinik für Kardiologie, Pneumologie und Angiologie
Verified postcode
Düsseldorf, Germany· Recruiting
HELIOS Klinikum Erfurt
Verified postcode
Erfurt, Germany· Recruiting
Universitätsklinikum Frankfurt, Med. Klinik III - Kardiologie, Angiologie
Verified postcode
Frankfurt am Main, Germany· Recruiting
Universitätsklinikum Halle
Verified postcode
Halle, Germany· Recruiting
Asklepios Klinik St. Georg
Verified postcode
Hamburg, Germany· Recruiting
SLK-Kliniken Heilbronn
Verified postcode
Heilbronn, Germany· Recruiting
Westpfalz-Klinikum GmbH, Klinik für Innere Medizin 2
Verified postcode
Kaiserslautern, Germany· Recruiting
Universitätsklinikum Leipzig
Verified postcode
Leipzig, Germany· Recruiting
Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
Verified postcode
Leipzig, Germany· Recruiting

Common questions

What is a 'catheter-directed treatment'?

It's a procedure where doctors use a thin tube guided through blood vessels to reach and treat a blood clot in your lungs, either by breaking it up or delivering medicine directly.

Why is this study important?

It helps doctors learn if adding the special catheter procedure to standard care is better for people with very serious blood clots in their lungs.

Will I know which treatment I'm getting?

Yes, this is an 'open label' study, meaning you and your doctors will know if you are receiving the catheter procedure or just standard care.

What if I get worse during the study?

Your medical team will monitor you closely, and your safety is their top priority. They will provide the best medical care if your condition changes, whether you are in the study or not.

Can I still get treatment if I don't join the study?

Absolutely. Choosing not to participate in the study will not affect the medical care you receive for your condition.

How to find out more

Karl Fengler, MD, Assoc. Prof.

karl.fengler@medizin.uni-leipzig.de +49 341 865-1426 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.