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DVT Burden and the Risk of Post-thrombotic Syndrome

Study acronym: DVT-Burden
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Re-verified, no change to tracked fieldsv15
  2. Minor Site details revised at 3 of 27 sitesv14
  3. Minor Re-verified, no change to tracked fieldsv13
  4. Minor Study sites: 24 to 27v12
  5. Minor Site details revised at 3 of 24 sitesv11
Show 9 earlier versionsHide 9 earlier versions
  1. Minor Study sites: 23 to 24
    • Eligibility criteria expanded, about 3 words
    v10
  2. Minor Site details revised at 3 of 23 sitesv9
  3. Notable Primary and study completion dates: Jun 2026 to Jun 2027
    • Study sites: 16 to 23
    • Eligibility criteria shortened, about 75 words
    • Study description expanded, about 7 words
    v8
  4. Minor Site details revised at 1 of 16 sitesv7
  5. Minor Site details revised at 3 of 16 sitesv6
  6. Minor Site details revised at 1 of 16 sitesv5
  7. Minor Site details revised at 6 of 16 sitesv4
  8. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 2024 to Jun 5, 2024
    • Site details revised at 16 of 16 sites
    v3
  9. Minor Study sites: 15 to 16v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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. 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.
Trial Details
NCT Number NCT06385353
Lead Sponsor Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Collaborators: Assistance Publique Hopitaux De Marseille, F-CRIN INNOVTE Research Network
Conditions
(from sponsor)
Postthrombotic Syndrome
Related terms Postthrombotic Syndrome, Venous Thrombosis
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov