RecruitingPHASE4INTERVENTIONAL

Clinical Surveillance vs. Anticoagulation for Low-risk Patients With Isolated Subsegmental Pulmonary Embolism

This study is about a specific type of blood clot in the lungs, called an isolated subsegmental pulmonary embolism (SSPE). These are very small clots that only affect the tiniest blood vessels in the lungs. Doctors are not sure if these small clots always need treatment, as the usual blood-thinning medicines can cause bleeding. The study aims to find out if it's safe and effective for low-risk patients with these small clots to be carefully monitored without taking blood thinners, compared to those who do take blood thinners. The goal is to see if we can avoid unnecessary treatment and its risks, while still keeping patients safe and healthy.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

Drahomir Aujesky

Enrolment target

276

Start

15 May 2020

Estimated completion

01 May 2028

Pulmonary Embolism Embolism Embolism and Thrombosis Lung Diseases Cardiovascular Diseases Respiratory Tract Diseases Venous Thromboembolism Anticoagulant-induced Bleeding Bleeding

What is this study about?

When you have a blood clot in your lungs, it's called a pulmonary embolism (PE). This study is looking at a very specific type of PE, known as an isolated subsegmental pulmonary embolism (SSPE). Imagine your lungs have many tiny branches, like a tree. An SSPE is a clot in one of the smallest branches, meaning it only affects a very small part of your lung.

Currently, it's not clear whether these small clots always need to be treated with blood-thinning medicines. While these medicines are very good at preventing clots from getting bigger or new ones from forming, they can also increase your risk of bleeding. The study wants to understand if, for people who are otherwise healthy and at low risk, closely watching these small clots without giving blood-thinning medicine (like rivaroxaban) is a safe and effective approach. This could potentially help patients avoid the side effects of medication.

By comparing close monitoring to standard blood-thinning treatment, the researchers hope to find the best and safest way to manage these small clots. This could lead to a better understanding of how to treat SSPEs, making care more tailored and reducing risks for patients in the future.

Key takeaways

Looks at small lung clots in low-risk patients.
Compares careful watching to blood-thinning medicine.
Aims to reduce risks like bleeding from unnecessary treatment.
Participation involves monitoring and possibly rivaroxaban.
You can withdraw from the study at any time.
Helps understand the best care for these specific clots.

Who may be eligible?

This study is looking for adults aged 18 or older who have been diagnosed with a small blood clot in their lungs (isolated subsegmental pulmonary embolism), whether they have symptoms or not. You would need to agree to take part by signing a consent form.

However, there are several reasons why you might not be able to join. For example, if you have other types of blood clots, like in your legs or arms, or if you have active cancer. You also wouldn't be eligible if you've had certain types of blood clots before, if you're very unwell, or if you have a high risk of bleeding.

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 you been diagnosed with a small lung clot (isolated subsegmental pulmonary embolism)?
Do you have any other blood clots in your legs or arms?
Do you have active cancer?
Are you currently pregnant or breastfeeding?
Are you able to agree to take part in the study?

Answer every question to see your result.

What does participation involve?

If you join the study, you will either be carefully monitored without receiving blood-thinning medication, or you will receive a blood-thinning medication called rivaroxaban. The specific details of how long you'd be involved, how often you'd have appointments, and what tests would be done would be fully explained to you. These details can vary, but typically involve regular check-ups with the study team to monitor your health and the clot. This is to ensure your safety and to see how your body responds to either the watchful waiting approach or the medication. The total duration of your participation would be clearly outlined before you start.

Potential risks and benefits

Participating in this study might benefit you by contributing important information that could help future patients with similar small blood clots in their lungs. You would receive careful monitoring, which is a benefit in itself. However, there are potential risks, depending on which group you are in. If you are in the group that doesn't receive blood thinners, there's a small chance the clot could worsen or you could develop new clots. If you are in the group receiving blood thinners, there's a risk of bleeding. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (40)

Cliniques Universitaires Saint-Luc
Verified postcode
Woluwe-Saint-Lambert, Belgium· Recruiting
Centre hospitalier universitaire de Liege
Verified postcode
Liège, Belgium· Recruiting
The Ottawa Hospital
Verified postcode
Ottawa, Canada· Recruiting
Hôpital Bicêtre - APHP
Verified postcode
Le Kremlin-Bicêtre, France· Recruiting
Centre Hospitalier Regional Et Universitaire De Brest
Verified postcode
Brest, France· Recruiting
CHU Gabriel-Montpied
Verified postcode
Clermont-Ferrand, France· Recruiting
Centre Hospitalier Universitaire De Dijon
Verified postcode
Dijon, France· Recruiting
Hospital Edouard Herriot
Verified postcode
Lyon, France· Recruiting
Hôpitaux universitaires de Marseille Timone AP-HM
Verified postcode
Marseille, France· Recruiting
CHU De Rouen
Verified postcode
Rouen, France· Recruiting
CHU ST Etienne - Hôpital Nord
Verified postcode
Saint-Priest-en-Jarez, France· Recruiting
Albert Schweitzer Ziekenhuis Dordrecht
Verified postcode
Dordrecht, Netherlands· Recruiting

Common questions

What is an isolated subsegmental pulmonary embolism?

It's a very small blood clot in one of the tiny blood vessels in your lungs. 'Isolated' means there are no other significant clots elsewhere.

Why is this study important?

It's important because doctors aren't sure if these very small clots always need blood-thinning medicine, which can have side effects. This study aims to find the safest treatment.

What is 'clinical surveillance'?

Clinical surveillance means your doctors will closely monitor your health and the clot without immediately giving blood-thinning medication, to see how you progress.

Will I definitely get blood-thinning medicine if I join?

No, you might be in the group that is carefully monitored without blood thinners, or in the group that receives a blood-thinning medicine called rivaroxaban.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time without having to give a reason, and your regular medical care will not be affected.

How to find out more

Drahomir Aujesky, Prof. MD MSc

safe-sspe@insel.ch +41 31 632 88 84 Official trial record

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