NCT06385353 DVT Burden and the Risk of Post-thrombotic Syndrome
| NCT ID | NCT06385353 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer |
| Condition | Postthrombotic Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2024-06-05 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2024-06-05 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years 2. 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) 3. Affiliates or beneficiaries of a social security scheme. Exclusion Criteria: 1. Pregnant women, women in labour or breastfeeding mothers. 2. 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. 3. Asymptomatic venous thrombosis. 4. Symptomatic venous thrombosis of both lower limbs (patients with bilateral deep venous thrombosis but symptomatic on one side only can be included). 5. History of ipsilateral or contralateral venous thrombosis of the lower limb. 6. Fracture or orthopedic surgery of the lower limbs in the last 3 months. 7. 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. 8. Prophylactic or therapeutic anticoagulant treatment \> 5 days. 9. Expected duration of anticoagulant treatment \< 3 months (all patients must have a minimum treatment of 3 months). 10. Patient estimated at high risk of bleeding according to investigator clinical judgment (renal, platelet, digestive, hepatic, neurological... origin) . 11. Indication for interruption of the inferior vena cava or venous recanalisation (endovascular, thrombolysis or surgery). 12. Refusal or inability to give written informed consent to participate in the study. 13. Life expectancy \< 6 months. 14. Patients under legal protection (guardianship, curatorship, etc.) or safeguard of justice. 15. Patients taking part in a research project for venous thromboembolism that can interfere with the conduct of DVT-BURDEN research.
Contact & Investigator
Antoine ELIAS
STUDY DIRECTOR
Centre Hospitalier Intercommunal Toulon La Seyne-sur-Mer
Frequently Asked Questions
Who can join the NCT06385353 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Postthrombotic Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06385353 currently recruiting?
Yes, NCT06385353 is actively recruiting participants. Contact the research team at magali.cesana@ch-toulon.fr for enrollment information.
Where is the NCT06385353 trial being conducted?
This trial is being conducted at Vichy, France, Carcassonne, France, Aubagne, France, Marseille, France and 11 additional locations.
Who is sponsoring the NCT06385353 clinical trial?
NCT06385353 is sponsored by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer. The principal investigator is Antoine ELIAS at Centre Hospitalier Intercommunal Toulon La Seyne-sur-Mer. The trial plans to enroll 400 participants.