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

Launched by UNIVERSITY HOSPITAL, BREST · Dec 11, 2024

Keywords

ClinConnect Summary

The ETHER trial is studying a new approach to manage a condition called unprovoked venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary embolism (PE). These conditions happen when blood clots form in the veins and can be serious if not treated. While anticoagulant treatments (medications that prevent blood clots) are effective, they also carry a risk of bleeding. This trial aims to improve decision-making about how long patients should stay on anticoagulants after their first episode of unprovoked VTE, emphasizing collaboration between patients and doctors. By using personalized risk assessments, the goal is to find a balance that keeps patients safe while reducing the chances of blood clots returning.

To participate in this trial, you must be at least 18 years old and have had a first episode of symptomatic unprovoked PE or DVT, treated with anticoagulants for 3 to 6 months. If you join, you can expect to work closely with your healthcare team to discuss your treatment options and help decide the best course for your situation. This trial is a chance to contribute to an important study that could improve long-term care for patients with similar conditions, while also potentially enhancing your own treatment experience.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient \> or = 18 years,
• • Patient with a first episode of symptomatic unprovoked pulmonary embolism (PE) and/or proximal deep vein thrombosis (DVT) treated for 3 to 6 uninterrupted months with full dose anticoagulant therapy,
• • Signed informed consent.
• Exclusion Criteria:
• • Unable or refusal to give informed consent,
• • Isolated distal DVT,
• • Isolated sub-segmental PE
• • Previous unprovoked VTE
• • Known CTEPH
• • Indication for anticoagulation other than DVT or PE (e.g.; atrial fibrillation, mechanic valves...),
• • Interruption of anticoagulation for 14 days or more before the inclusion,
• • Active cancer of less than 24 months,
• • Current pregnancy,
• • Life expectancy \<18 months (e.g.; patients with an end-stage chronic disease)
• • Not affiliated to national insurance, social security (only for France)