All studies
RecruitingNAINTERVENTIONAL

Shared Decision-making Process for Unprovoked vEnous THromboEmbolism Management. (ETHER )

This study, called ETHER, is about helping people with a specific type of blood clot called an 'unprovoked venous thromboembolism' (VTE). This happens when a clot forms without a clear reason. Normally, patients take blood thinners to prevent new clots, but these medicines also carry a risk of bleeding. The research team wants to find the best way to decide how long patients should keep taking these blood thinners. They're trying out a new approach where doctors and patients make decisions together, using special tools to predict risks and understand the patient's individual situation. The aim is to reduce further clots, bleeding, and improve patient satisfaction, ultimately helping people lead healthier lives.

At a glance

Status
Recruiting
Phase
NA
Sponsor
University Hospital, Brest
Enrolment target
2,400
Start
30 Oct 2025
Estimated completion
01 Oct 2035

What is this study about?

If you've had a blood clot, also known as a venous thromboembolism (VTE), you'll know how serious it can be. This can include deep vein thrombosis (DVT), a clot usually in your leg, or pulmonary embolism (PE), a clot that travels to your lungs. While blood thinners (anticoagulants) are very effective at reducing the risk of another clot and saving lives, they also carry a risk of bleeding, which can sometimes be severe. This can make deciding how long to stay on these medications quite tricky.

For many people, a blood clot happens because of something specific, like having major surgery or being unable to move for a long time. In these cases, treatment often lasts for about three months. However, for more than half of people, a blood clot happens 'out of the blue' – doctors call this 'unprovoked' VTE. If you've had an unprovoked VTE, there's a higher chance of it happening again. Because of this, current advice often suggests taking blood thinners indefinitely.

But taking blood thinners long-term means a continued risk of bleeding. This study wants to find a better way to balance the risk of another clot against the risk of bleeding. The ETHER study is testing a new way for doctors and patients to work together to make this important decision. They will use special tools that combine your personal risk factors with an understanding of your experiences to help decide the best length of time for your blood thinner treatment. The hope is that this shared decision-making approach will lead to better outcomes, fewer complications, and happier patients.

Key takeaways

  • Targets adults with a first 'unprovoked' blood clot.
  • Aims to improve decisions about blood thinner treatment length.
  • Focuses on doctors and patients making choices together.
  • Hopes to reduce future blood clots AND bleeding risks.
  • Also looking at patient satisfaction with their treatment plan.

Who may be eligible?

This study is looking for adults aged 18 or older who have had their first-ever blood clot (either a DVT in a main vein or a PE in the lung) that occurred without a clear cause. You must have already completed between three and six months of continuous blood thinner treatment for this clot.

You can't join the study if you've had a blood clot before, or if your clot was in a very small vein (distal DVT) or a very small part of the lung (sub-segmental PE). Also, if you need blood thinners for other health conditions like an irregular heartbeat (atrial fibrillation) or a mechanical heart valve, this study isn't for you. People currently pregnant, or those with very advanced illnesses meaning a life expectancy of less than 18 months are also not suitable. Finally, if you've recently had active cancer (in the last two years), you won't be able to participate.

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.

  1. Are you 18 years old or over?
  2. Have you had your first blood clot (DVT or PE) that wasn't caused by a specific event?
  3. Have you been on blood thinners for 3 to 6 months for this clot?
  4. Do you not have an active cancer diagnosis from the last two years?
  5. Are you not currently pregnant?
Answer every question to see your result.

What does participation involve?

If you join this study, your involvement will focus on how decisions are made about your blood thinner treatment. You'll work closely with your healthcare team to decide the best length of time for your treatment, using special tools to help guide this discussion. You'll have regular check-ups, and the medical team will monitor your health, including looking for any signs of new blood clots or bleeding. The total duration of your participation will depend on the decisions made about your treatment, as the study aims to follow your health over time.

Potential risks and benefits

Participating in this study might offer you the benefit of a more personalised approach to managing your blood clot treatment, potentially leading to a better balance between preventing future clots and reducing bleeding risks. You'll also be contributing valuable information that could help others with similar conditions in the future. However, as with any medical decision involving blood thinners, there's always a risk of bleeding, which your doctors will help you monitor. You are free to withdraw from the study at any time without affecting your medical care.

Locations (20)

  • CHU Brest
    Verified postcode
    Brest, France· Recruiting
  • CHU d'Amiens - Picardie
    Verified postcode
    Amiens, France· Not yet recruiting
  • CHU d'Angers
    Verified postcode
    Angers, France· Not yet recruiting
  • Hôpital National d'Instruction des Armées Percy
    Verified postcode
    Clamart, France· Not yet recruiting
  • CHU de Clermont Ferrand
    Verified postcode
    Clermont-Ferrand, France· Not yet recruiting
  • APHP-Colombes
    Verified postcode
    Colombes, France· Not yet recruiting
  • CHU de Dijon - Hôpital François Mitterand
    Verified postcode
    Dijon, France· Not yet recruiting
  • CH Le Mans
    Verified postcode
    Le Mans, France· Not yet recruiting
  • HCL - Hôpital Edouard Herriot
    Verified postcode
    Lyon, France· Not yet recruiting
  • APHM - Hôpital la Timone
    Verified postcode
    Marseille, France· Not yet recruiting
  • CHU de Montpellier
    Verified postcode
    Montpellier, France· Not yet recruiting
  • CHU de Nancy
    Verified postcode
    Nancy, France· Not yet recruiting

Common questions

What is an 'unprovoked' blood clot?

It's a blood clot that happens without a clear reason, like major surgery or a long period of being unable to move.

Why is it important to decide how long to take blood thinners?

Blood thinners prevent new clots but can also cause bleeding. Finding the right balance is key to keeping you safe and healthy.

What is 'shared decision-making'?

It's when you and your doctor work together to make choices about your care, considering your medical information and what matters most to you.

Will I have to stop my blood thinners if I join?

The study is about helping to decide the best duration of treatment, so that might involve discussing whether to continue or stop them, based on your individual risk factors and preferences.

Will joining the study affect my usual healthcare?

No, your regular healthcare will continue. This study is designed to enhance decisions about your specific blood clot treatment.

How to find out more

Francis COUTURAUD, Prof.

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

Interested in taking part?

Register your interest

Share your details and the research team for "Shared Decision-making Process for Unprovoked vEnous THrombo…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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