Decision Aid for Anticoagulation Duration After Unprovoked Venous Thromboembolism
A legfontosabb adatok
- Ki végzi
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Hol
- Kanada5 helyszín, 1 országbanVálassz országot a helyszínekhez
- Azonosító
- Állapot
- Toborzás még nem indult
- Résztvevők
- 850 fő, tervezett
- Kezdés
- 2026. szept.
- Várható befejezés
- 2029. márc.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoportAz egyik csoport nem kap vizsgálati kezelést, összehasonlításként.
- A vizsgált kezelések
- DECIDE-VTE Patient Decision Aid
- A regiszteradat frissítve
- 2026. június 24.
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 who had a first blood clot in a deep vein or lung with no clear or only a weak cause. They have taken blood thinners for at least 3 months and must decide whether to continue.
- Életkor
- 18 years or older
- Nem
- All sexes
- A betegség stádiuma
- First confirmed clot in a large (proximal) deep leg vein and/or a segmental or larger lung clot (pulmonary embolism), with no clear or only a weak cause. Enrolment within 12 months of the diagnosis.
- Korábbi kezelés
- At least 3 months of full-dose blood thinner treatment, and still taking it now. No earlier dedicated visit to decide long-term blood thinner use.
A részvétel fő kizáró okai
- More than one clot with no clear or only a weak cause
- Clot caused by a strong trigger such as major surgery, major injury, a plaster cast or long bed rest, or a lasting trigger such as active cancer
- Women at very low risk of another clot (HERDOO2 score 0-1)
- High bleeding risk, so blood thinners should be stopped
- Need for long-term blood thinners for another reason, such as atrial fibrillation
A regiszter feltételei, szó szerint
Mind a 14 feltétel megnézéseKevesebb
Ki vehet részt
- Age 18 years or older
- First episode of objectively confirmed unprovoked or weakly provoked venous thromboembolism (VTE)
- Objectively confirmed proximal deep vein thrombosis and/or segmental or greater pulmonary embolism
- Completed at least 3 months of therapeutic anticoagulation and currently receiving anticoagulation
- Enrollment within 12 months of diagnosis of the index/qualifying VTE event
- Able to provide written informed consent
- Able to participate in shared decision-making in English or French
Ki nem vehet részt
- Index/qualifying VTE is a strongly provoked VTE (e.g., associated with major surgery, major trauma, plaster cast immobilization, or prolonged bed rest)
- Prior dedicated long-term anticoagulation Decision Visit regarding anticoagulation duration
- Index/qualifying VTE associated with a persistent strong provoking risk factor (e.g., active cancer or ongoing immobility)
- High bleeding risk such that anticoagulation should be discontinued
- Recurrent unprovoked or weakly provoked VTE I(i.e. multiple unprovoked/weakly provoked VTE)
- Women at very low recurrence risk (HERDOO2 score 0-1)
- Requirement for long-term anticoagulation for another indication (e.g., atrial fibrillation)
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 and pulmonary embolism, is a common condition that is typically treated with blood thinners (anticoagulants). After completing at least 3 months of treatment for a first unprovoked or weakly provoked VTE, patients and clinicians must decide whether to stop anticoagulation or continue treatment for a longer period. Continuing anticoagulation reduces the risk of another blood clot but increases the risk of bleeding. Because both options involve important benefits and risks, this decision should reflect the patient's values and preferences.
A teljes eredeti leírásKevesebb
The DECIDE-VTE study will evaluate whether a patient decision aid can improve decision-making for patients facing this choice. The decision aid provides evidence-based information about the risks and benefits of continuing versus stopping anticoagulation and includes a values clarification exercise to help patients identify what matters most to them.
This multicentre batched stepped-wedge cluster randomized trial will be conducted in 12 thrombosis clinics across Canada. Clinics will transition from usual care to implementation of the patient decision aid according to a randomized schedule. The primary outcome is decisional conflict immediately following the anticoagulation decision visit, measured using the Decisional Conflict Scale. Secondary outcomes include patient knowledge, treatment decisions, decisional regret, concordance with the chosen treatment strategy, recurrent venous thromboembolism, major bleeding, all-cause mortality, and implementation outcomes.
A vizsgálat 2 csoportja
- Usual CareNincs vizsgálati kezelés, összehasonlításként
Participants receive standard thrombosis clinic care and clinician-patient discussions regarding continuation versus discontinuation of anticoagulation following a first unprovoked or weakly provoked venous thromboembolism. No structured patient decision aid is used.
- DECIDE-VTE Patient Decision AidA vizsgált kezelés
Participants receive the DECIDE-VTE Patient Decision Aid in addition to usual thrombosis clinic care. The decision aid provides evidence-based information regarding the risks and benefits of continuing versus discontinuing anticoagulation after a first unprovoked or weakly provoked venous thromboembolism and includes a structured values clarification exercise to support shared decision-making. Participants and clinicians make the final treatment decision together during the Decision Visit.
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
- Enabling and Engaging Patients to Decide Indefinite Versus Short-Term Anticoagulation for Venous Thromboembolism (DECIDE-VTE)
- MI-összefoglaló
- A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 15.
- A regiszteradat frissítve
- 2026. június 24.