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DVT Burden and the Risk of Post-thrombotic Syndrome

A legfontosabb adatok

Ki végzi
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Hol
Franciaország26 helyszín, 1 országbanVálassz országot a helyszínekhez
Azonosító
Állapot
Toboroz
Résztvevők
400 fő, tervezett
Kezdés
2024. jún. 5.
Várható befejezés
2027. jún.
A vizsgálat típusa
Beavatkozással járó
A vizsgált kezelések
  • Quantification of deep vein thrombosis burden and assessment of post-thrombotic syndrome
A regiszteradat frissítve
2026. július 7.

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 with a first, sudden blood clot in a deep leg vein that causes symptoms. It studies whether the clot size predicts later leg problems (post-thrombotic syndrome).

Életkor
18 years and older
Nem
All sexes
A betegség stádiuma
Acute deep vein thrombosis of the legs with symptoms, confirmed by ultrasound. People with a stable lung clot linked to the leg clot can join.
Korábbi kezelés
Cannot join after more than 5 days of blood thinner treatment (preventive or full dose). Blood thinner treatment must be planned for at least 3 months.

A részvétel fő kizáró okai

  • Pregnant, in labour or breastfeeding
  • Unstable lung clot (systolic blood pressure < 90 mmHg, shock or cardiac arrest)
  • Earlier blood clot in either leg, or symptoms in both legs
  • Leg fracture or leg bone surgery in the last 3 months
  • High bleeding risk, or life expectancy < 6 months

A regiszter feltételei, szó szerint

Mind a 18 feltétel megnézéseKevesebb

Ki vehet részt

  • Age ≥ 18 years
  • Patients with symptomatic acute deep venous thrombosis of the lower limbs confirmed by ultrasound on the criteria of venous incompressibility and direct image of the thrombus (patients with stable pulmonary embolism associated with a symptomatic deep venous thrombosis can be included)
  • Affiliates or beneficiaries of a social security scheme

Ki nem vehet részt

  • Fracture or orthopedic surgery of the lower limbs in the last 3 months
  • Indication for interruption of the inferior vena cava or venous recanalisation (endovascular, thrombolysis or surgery)
  • Pulmonary embolism haemodynamically unstable defined by systolic blood pressure < 90 mmHg or a drop in systolic blood pressure of at least 40 mmHg during at least 15 min, shock or cardiac arrest
  • Asymptomatic venous thrombosis
  • Symptomatic venous thrombosis of both lower limbs (patients with bilateral deep venous thrombosis but symptomatic on one side only can be included)
  • History of ipsilateral or contralateral venous thrombosis of the lower limb
  • Patients taking part in a research project for venous thromboembolism that can interfere with the conduct of DVT-BURDEN research
  • Patient estimated at high risk of bleeding according to investigator clinical judgment (renal, platelet, digestive, hepatic, neurological... origin)
  • Dependance caused by age or secondary to a chronic affection, going from the inability to stand up or walk alone without help to bed or armchair rest over
  • Pregnant women, women in labour or breastfeeding mothers
  • Prophylactic or therapeutic anticoagulant treatment > 5 days
  • Expected duration of anticoagulant treatment < 3 months (all patients must have a minimum treatment of 3 months)
  • Refusal or inability to give written informed consent to participate in the study
  • Life expectancy < 6 months
  • Patients under legal protection (guardianship, curatorship, etc.) or safeguard of justice

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

Post-thrombotic syndrome (PTS) is the most common chronic complication of deep vein thrombosis (DVT), with major consequences for patient quality of life and cost of management. Identifying patients at high risk of developing PTS could be useful for its prevention and may lead to more appropriate therapeutic strategies to reduce its incidence and severity.

A teljes eredeti leírásKevesebb

Prognostic tools for predicting risk are very useful for choosing the optimum treatment and improving patient management and are a preliminary step before developing predictive models useful for determining sensitivity to treatment. At present, although several prognostic markers and models have been proposed, it is still difficult to predict who will develop a PTS or a moderate to severe PTS. The development of PTS is multifactorial and depends largely on the extent and severity of venous obstruction which supports the theory of thrombosis burden (DVT-Burden) as a potential prognostic marker for PTS. It therefore seems important to study the association between thrombosis burden and the occurrence of PTS.

The Venous Volumetric Index or VVI (Ouriel 1999) will be used for quantifying DVT-Burden. The VVI was constructed by calculating the volume from the diameter and length of 14 venous segments from the calf veins to the inferior vena cava. The VVI has been validated for its ability to discriminate between symptomatic and asymptomatic DVT and has shown superior performance to other methods for quantifying DVT.

This study aim to assess the performance of baseline DVT-burden estimated by the VVI score on ultrasound for predicting the occurrence and the severity of PTS as assessed by the Villalta scale at 6 months.

A vizsgálat csoportja

  • Association between thrombosis burden and occurrence of PTSA vizsgált kezelés

    Kezelés: Quantification of deep vein thrombosis burden and assessment of post-thrombotic syndrome

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
Baseline Ultrasound Venous Thrombosis Burden and the Risk of Post-thrombotic Syndrome in Patients With a First Acute Episode of Symptomatic Deep Vein Thrombosis of the Lower Limbs - The "DVT-Burden" Project -
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 15.
A regiszteradat frissítve
2026. július 7.