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New treatment option for Postthrombotic Syndrome
Official title DVT Burden and the Risk of Post-thrombotic Syndrome
ClinicalTrials.gov ID: NCT06385353
What this study is testing
- What it's testing
- 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 plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years
- Patients with symptomatic acute deep venous thrombosis of the lower limbs confirmed by ultrasound on the criteria of venous incompressibility and...
- Affiliates or beneficiaries of a social security scheme.
You likely can't join if
- Pregnant women, women in labour or breastfeeding mothers.
- Pulmonary embolism haemodynamically unstable defined by systolic blood pressure \< 90 mmHg or a drop in systolic blood pressure of at least 40 mmHg...
- 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.
- Fracture or orthopedic surgery of the lower limbs in the last 3 months.
See the full eligibility criteria
- 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...
- Affiliates or beneficiaries of a social security scheme.
- Pregnant women, women in labour or breastfeeding mothers.
- 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.
- Fracture or orthopedic surgery of the lower limbs in the last 3 months.
- 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.
- Prophylactic or therapeutic anticoagulant treatment \> 5 days.
- Expected duration of anticoagulant treatment \< 3 months (all patients must have a minimum treatment of 3 months).
- Patient estimated at high risk of bleeding according to investigator clinical judgment (renal, platelet, digestive, hepatic, neurological... origin) .
- Indication for interruption of the inferior vena cava or venous recanalisation (endovascular, thrombolysis or surgery).
- 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.
- Patients taking part in a research project for venous thromboembolism that can interfere with the conduct of DVT-BURDEN research.
The study team makes the final eligibility decision.
Where it's taking place
- Vichy, Allier, France
- Carcassonne, Aude, France
- Aubagne, Bouches-du-Rhône, France
- Marseille, Bouches-du-Rhône, France
- Martigues, Bouches-du-Rhône, France
- Ajaccio, Corse-du-sud, France
- Dijon, Côte d'Or, France
- Besançon, Doubs, France
- Brest, Finistère, France
- Toulouse, Haut-Garonne, France
- Toulouse, Haute-Garonne, France
- Montoir-de-Bretagne, Loire-Atlantique, France
- Saint-Priest-en-Jarez, Pays de la Loire Region, France
- Lyon, Rhône, France
- Amiens, Somme, France
- Fréjus, Var, France
- Ollioules, Var, France
- Saint-Raphaël, Var, France
- Sanary-sur-Mer, Var, France
- Six-Fours-les-Plages, Var, France
+ 4 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vichy, Allier, France; Carcassonne, Aude, France; Aubagne, Bouches-du-Rhône, France; Marseille, Bouches-du-Rhône, France; Martigues, Bouches-du-Rhône, France; Ajaccio, Corse-du-sud, France and 18 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.