RecruitingNAINTERVENTIONAL

DVT Burden and the Risk of Post-thrombotic Syndrome

This study investigates if the amount of deep vein thrombosis (DVT) in a person's veins, called DVT burden, can help predict who will develop post-thrombotic syndrome (PTS). PTS is a common and often uncomfortable condition that can happen after DVT, affecting quality of life. Researchers will use a special ultrasound measurement called the Venous Volumetric Index (VVI) to estimate the DVT burden in patients with a new DVT. The aim is to see if this measurement can help doctors understand a patient's risk of developing PTS and how severe it might be. Finding better ways to predict PTS means doctors could offer more targeted treatments and support to prevent it or reduce its impact.

At a glance

Status

Recruiting

Phase

Sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Enrolment target

400

Start

05 Jun 2024

Estimated completion

01 Jun 2027

Postthrombotic Syndrome

What is this study about?

When someone has a Deep Vein Thrombosis (DVT), which is a blood clot in a deep vein, there's a chance they might develop a longer-term problem called Post-thrombotic Syndrome (PTS). PTS can cause ongoing symptoms like pain, swelling, and skin changes in the affected leg, making everyday life difficult. Currently, it's hard for doctors to know who will develop PTS and how bad it will be.

This study is trying to understand if the "burden" or amount of DVT a person has in their leg when they are first diagnosed can help predict their risk of getting PTS. Think of it like this: if you have a small bruise versus a very large one, the large one might cause more problems. Similarly, researchers want to see if a larger DVT burden means a higher chance of developing PTS or more severe symptoms.

To do this, the study will use a special ultrasound measurement called the Venous Volumetric Index (VVI). This VVI score helps to measure the amount and spread of the DVT. By comparing this score at the beginning of the study with whether a patient develops PTS later on, doctors hope to find a way to better predict who is at higher risk. This knowledge could lead to better ways to prevent PTS or more effective treatments for those who do develop it.

Key takeaways

This study investigates if the amount of DVT can predict future leg problems (PTS).
It uses a special ultrasound scan to measure the DVT burden.
Participation involves clinic visits, ultrasound scans, blood tests, and questionnaires.
The study helps doctors understand who is at risk of PTS to improve prevention and treatment.
No new treatments or medications are given in this study.
Your participation lasts for about 6 months.

Who may be eligible?

To join this study, you need to be at least 18 years old and have recently been diagnosed with your first Deep Vein Thrombosis (DVT) in one of your legs, which has been confirmed by an ultrasound scan and is causing symptoms. It's okay if you also have a blood clot in your lungs (pulmonary embolism) at the same time, as long as it's not severe or unstable.

There are several reasons why you wouldn't be able to join. For example, if you are pregnant, breastfeeding, or if your DVT isn't causing any symptoms. You also can't join if you've had a DVT in the same leg (or the other leg) before, or if you've had a recent leg fracture or major leg surgery in the last three months. The study also cannot include very unwell patients, those with certain bleeding risks, or those who need specific advanced treatments like an IVC filter or clot-busting procedures.

Finally, you must be able to give written consent to participate and not be involved in another DVT research study that might affect the results of this one. You also need to expect to live for at least six more months and be able to stand and walk on your own.

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 recently been diagnosed with your first leg DVT, and is it causing symptoms?
Are you NOT currently pregnant or breastfeeding?
Have you NOT had a DVT in the same leg (or the other leg) before?
Are you able to stand and walk on your own?
Are you NOT currently in another DVT research study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, your participation will last for about six months. During this time, you'll have several visits to the clinic.

At each visit (at the start, then at one month, three months, and six months), the medical team will check your symptoms and examine your leg to assess for PTS. You'll also have an ultrasound scan of your leg to measure your DVT. At selected visits (at the start, one week, one month, and three months), blood samples will be taken for research purposes to look at things like inflammation and how your blood clots.

Towards the end of the study, at the three and six-month visits, you'll be asked to fill out two questionnaires about your quality of life. Your involvement in the study will finish after your six-month visit.

Potential risks and benefits

Potential benefits of taking part include contributing to a better understanding of Deep Vein Thrombosis and Post-thrombotic Syndrome, which could help future patients. You will also have close medical monitoring of your DVT and leg. Potential risks are generally low, mainly related to blood draws (such as mild bruising or discomfort) and the time commitment for clinic visits and questionnaires. There are no new medications or treatments given as part of this study. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (27)

CH de Vichy
Verified postcode
Vichy, France· Not yet recruiting
Centre Hospitalier de Carcassonne
Verified postcode
Carcassonne, France· Recruiting
Hôpital d'Aubagne
Verified postcode
Aubagne, France· Not yet recruiting
Hôpital Saint Joseph
Verified postcode
Marseille, France· Recruiting
Hôpital La Timone, AP-HM
Verified postcode
Marseille, France· Recruiting
Cabinet libéral
Verified postcode
Martigues, France· Terminated
Cabinet libéral
Verified postcode
Ajaccio, France· Recruiting
Cabinet libéral
Verified postcode
Ajaccio, France· Recruiting
CHU de Dijon
Verified postcode
Dijon, France· Recruiting
CHU de Besançon
Verified postcode
Besançon, France· Recruiting
Centre Hospitalier Universitaire de Brest
Verified postcode
Brest, France· Recruiting
Clinique Rive Gauche
Verified postcode
Toulouse, France· Recruiting

Common questions

What is Deep Vein Thrombosis (DVT)?

DVT is a blood clot that forms in a deep vein, usually in the leg. It can cause pain, swelling, and warmth in the affected leg.

What is Post-thrombotic Syndrome (PTS)?

PTS is a long-term problem that can happen after a DVT. It causes ongoing symptoms like pain, swelling, aching, and sometimes skin changes in the affected leg.

Will I get new medication in this study?

No, this study does not involve giving you any new medications or treatments. It's about monitoring your condition and collecting information.

How long will I be in the study?

Your participation in the study will last for about six months, with several clinic visits during that time.

Can I leave the study at any time?

Yes, you are free to withdraw from the study at any point, and it will not affect your ongoing medical care.

How to find out more

Magali CESANA

magali.cesana@ch-toulon.fr 0483772060 Official trial record

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