Shared Decision-making Process for Unprovoked vEnous THromboEmbolism Management. (ETHER )
A legfontosabb adatok
- Ki végzi
- University Hospital, Brest
- Hol
- Franciaország19 helyszín, 1 országbanVálassz országot a helyszínekhez
- Azonosító
- Állapot
- Toboroz
- Résztvevők
- 2400 fő, tervezett
- Kezdés
- 2025. okt. 30.
- Várható befejezés
- 2035. okt.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
- A vizsgált kezelések
- Usual Care Group
- shared decision-making process
- A regiszteradat frissítve
- 2025. november 28.
Ki vehet részt
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.
The trial is looking for adults after a first blood clot in the lung or deep leg veins with no clear cause. They must already have had 3 to 6 months of blood thinner treatment.
- Életkor
- 18 years or older
- Nem
- All sexes
- A betegség stádiuma
- First episode of symptomatic unprovoked pulmonary embolism (clot in the lung) and/or proximal deep vein thrombosis (clot in a deep vein near the trunk). Unprovoked means no clear cause was found.
- Korábbi kezelés
- Must have been treated for 3 to 6 uninterrupted months with full dose anticoagulant (blood thinner) therapy. Cannot join if blood thinners were stopped for 14 days or more before joining.
A részvétel fő kizáró okai
- A clot only in the lower leg veins, or only in small lung arteries (sub-segmental PE)
- A previous unprovoked clot, or known CTEPH (long-lasting high blood pressure in the lungs from clots)
- Another reason for blood thinners, such as atrial fibrillation or mechanical heart valves
- Active cancer of less than 24 months, or life expectancy under 18 months
- Current pregnancy
A regiszter feltételei, szó szerint
Mind a 14 feltétel megnézéseKevesebb
Ki vehet részt
- 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
Ki nem vehet részt
- Previous unprovoked VTE
- Active cancer of less than 24 months,
- Life expectancy <18 months (e.g.; patients with an end-stage chronic disease)
- Unable or refusal to give informed consent,
- Isolated distal DVT,
- Isolated sub-segmental PE
- 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,
- Current pregnancy,
- Not affiliated to national insurance, social security (only for France)
Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.
Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.
A vizsgálatról
Mit akar kideríteni a vizsgálat
Venous thromboembolism (VTE) including deep vein thrombosis (DVT) and pulmonary embolism (PE) is a frequent disease and the third most common cause of cardiovascular death in the world after myocardial infarction and stroke. Anticoagulant therapy drastically reduces the risk of early VTE recurrence and death, but it exposes patients to a substantial risk of bleeding. Hence, determining the optimal duration of anticoagulant treatment for VTE is a major public health issue.
A teljes eredeti leírásKevesebb
When major transient risk factors for VTE are identified (major surgery, immobilization...), patients generally do not need to extend anticoagulation beyond 3 months, whereas for VTE diagnosed in the context of cancer, therapeutic anticoagulation is required for as long as the cancer is considered "active".
However, in more than 50% of cases, venous thromboembolic disease occurs spontaneously, i.e. without any significant clinically detectable circumstance (known as unprovoked venous thromboembolic disease). In such patients, the risk of recurrence is high (35% recurrence rate at 5 years, with a 10% risk of death per recurrence). Scientific societies therefore recommend continuing anticoagulant treatment "indefinitely" (i.e. without programming a stop date or long-term treatment). However, this practice exposes these patients to an ongoing, non-negligible increase in the risk of bleeding, which could ultimately exceed the risk of recurrence of venous thrombo-embolic disease.
Optimizing anticoagulant therapy beyond the first three to six months of treatment is therefore a crucial and challenging issue, which could improve the long-term prognosis of patients with unprovoked thromboembolic venous disease.
Based on the quantitative and qualitative approaches implemented in MORPHEUS project granted by European Commission (HORIZON-HLTH-2022-TOOL-11-01 call), the investigators have combined predictive personalized medicine, through the use of risk biomarkers, with a patient-centered model of medicine, which, while based on an understanding of the patient's experience, leading to develop Time-Dependent Multicomponent risk prediction scores and socIo-anthropological scales (TDMI) integrated in a shared decision-making process regarding anticoagulant treatment duration in patients with a first episode of unprovoked VTE.
The aim of this study is to demonstrate that this strategy, based on a medical decision-making process shared between patients and physicians and including TDMI, reduces the risk of recurrence of thromboembolic venous disease (fatal or non-fatal), the risk of bleeding and all-cause mortality, and is associated with greater patient satisfaction after a first episode of unprovoked thromboembolic venous disease.
A vizsgálat 2 csoportja
- Control armMár használt kezelés, összehasonlításként
Anticoagulant treatment management according to usual practice and international guidelines
Kezelés: Usual Care Group
- Experimental armA vizsgált kezelés
Shared decision-making process integrating time-dependent multicomponent risk prediction scores and socio-anthropological scales (TDMI)
Kezelés: shared decision-making process
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- Prognosis Improvement of Unprovoked vEnous THromboEmbolism With the Use of a Shared Decision-making Process Including a Time-dependent Multicomponent Risk Prediction Scores inteRvention.
- MI-összefoglaló
- A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 15.
- A regiszteradat frissítve
- 2025. november 28.