Status:

RECRUITING

DVT Burden and the Risk of Post-thrombotic Syndrome

Lead Sponsor:

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Collaborating Sponsors:

Assistance Publique Hopitaux De Marseille

F-CRIN INNOVTE Research Network

Conditions:

Postthrombotic Syndrome

Eligibility:

All Genders

18+ years

Phase:

NA

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 a...

Detailed Description

This is a multicenter prospective cohort study aiming at assessing baseline DVT-Burden and other prognostic factors for predicting the occurrence and the severity of PTS. Patients diagnosed with a fi...

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.

Key Trial Info

Start Date :

June 5 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 1 2027

Estimated Enrollment :

400 Patients enrolled

Trial Details

Trial ID

NCT06385353

Start Date

June 5 2024

End Date

June 1 2027

Last Update

April 13 2026

Active Locations (27)

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Page 1 of 7 (27 locations)

1

CH de Vichy

Vichy, Allier, France, 03200

2

Centre Hospitalier de Carcassonne

Carcassonne, Aude, France, 11010

3

Hôpital d'Aubagne

Aubagne, Bouches-du-Rhône, France, 13400

4

Hôpital Saint Joseph

Marseille, Bouches-du-Rhône, France, 13008