Postthrombotic SyndromeDVT-BurdenNCT06385353
DVT Burden and the Risk of Post-thrombotic Syndrome
A study testing Quantification of deep vein thrombosis burden and assessment of post-thrombotic syndrome in people with Postthrombotic Syndrome, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 27 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postthrombotic Syndrome
- What is being tested?
- Quantification of deep vein thrombosis burden and assessment of post-thrombotic syndrome
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 27 sitesFrance
- Study dates
- 5 Jun 2024to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
27 sites in 1 country. Contact the study team or a site near you to ask about taking part.
27 sites in 1 country
France27 sites, 23 recruiting
- Recruiting
Cabinet libéral
Ajaccio, Corse-du-sud, 20090
Jean-François SECONDI, dr.jf.secondi@gmail.com
- Recruiting
Cabinet libéral
Ajaccio, Corse-du-sud, 20090
Céline DE MARI, dr.celine.demari@gmail.com
- Recruiting
Centre Hospitalier Universitaire Amiens Picardie
Amiens, Somme, 830054
Simon SOUDET, Soudet.simon@chu-amiens.fr
- Not yet recruiting
Hôpital d'Aubagne
Aubagne, Bouches-du-Rhône, 13400
Walfroy Radix, MD, walfroy.radix@ch-aubagne.fr
- Recruiting
Centre Hospitalier d'Avignon
Avignon, Vaucluse, 84000
Olivier GRAS, GRAS.Olivier@ch-avignon.fr
- Recruiting
CHU de Besançon
Besançon, Doubs, 25030
Patricia Costa, MD, 03 81 66 82 27 ext. +33, pcosta@chu-besancon.fr
- Recruiting
Centre Hospitalier Universitaire de Brest
Brest, Finistère, 29069
Benjamin ESPINASSE, Benjamin.espinasse@chu-brest.fr
- Recruiting
Centre Hospitalier de Carcassonne
Carcassonne, Aude, 11010
Géraldine PAOLI-CAZANAVE, geraldine.paoli-cazanave@ch-carcassonne.fr
- Recruiting
CHU de Dijon
Dijon, Côte d'Or, 21000
Hélène Greigert, Pr, helene.greigert@chu-dijon.fr
- Terminated
Centre Hospitalier de Fréjus/Saint-Raphaël
Fréjus, Var, 83600
- Recruiting
Hospices Civils de Lyon, Hôpital Edouard Herriot
Lyon, Rhône, 69003
Judith CATELLA, judith.catella@chu-lyon.fr
- Recruiting
Hôpital Saint Joseph
Marseille, Bouches-du-Rhône, 13008
Benjamin Ally, MD, allybsa@gmail.com
- Recruiting
Hôpital La Timone, AP-HM
Marseille, Bouches-du-Rhône, 13385
Gabrielle SARLON-BARTOLI, Pr, gabrielle.sarlon@ap-hm.fr
- Terminated
Cabinet libéral
Martigues, Bouches-du-Rhône, 13500
- Terminated
Centre de Santé Polyvalent de UGESSAP
Montoir-de-Bretagne, Loire-Atlantique, 44550
- Recruiting
Centre Hospitalier Universitaire de Nantes
Nantes, 44000
Olivier ESPITIA, MD, 02 44 76 80 75 ext. +33, olivier.espitia@chu-nantes.fr
- Recruiting
Polyclinique Les Fleurs
Ollioules, Var, 83190
Anaïs CORNE, anaiscorne@gmail.com
- Recruiting
Hôpital Saint Joseph
Paris, 75014
Maxime Delrue, MD, mdelrue@ghpsj.fr
- Recruiting
Hôpital Européen Georges Pompidou
Paris, 75015
Guillaume GOUDOT, MD, guillaume.goudot@aphp.fr
- Recruiting
CHU Saint Etienne
Saint-Priest-en-Jarez, Pays de la Loire Region, 42270
Laurent Bertoletti, Pr, 04 77 12 75 96 ext. +33, laurent.bertoletti@chu-st-etienne.fr
- Withdrawn
Centre cardio-vasculaire Esterel
Saint-Raphaël, Var, 83700
- Recruiting
Cabinet libéral
Sanary-sur-Mer, Var, 83110
Colin RICHARD, colin.richard29@gmail.com
- Recruiting
Cabinet libéral
Six-Fours-les-Plages, Var, 83140
Sophia BENSEDRINE, sophia.ange@wanadoo.fr
- Recruiting
Centre Hospitalier Intercommunal Toulon La Seyne-sur-Mer
Toulon, Var, 830054
Jean-Noël POGGI, jeannoel.poggi@ch-toulon.fr
- Recruiting
Clinique Rive Gauche
Toulouse, Haut-Garonne, 31076
Sophie BOVEDA, sbovedafournier@gmail.com
- Recruiting
CHU de Toulouse
Toulouse, Haute-Garonne, 31400
Timothée DEGOUY, MD, degouy.t@chu-toulouse.fr
- Recruiting
CH de Vichy
Vichy, Allier, 03200
Fabrice ABBADIE, MD, fabrice.abbadie@ch-vichy.fr
About this study
Official title: 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 -
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.
Read more
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.
Read the 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 first episode of DVT of the lower limbs are recruited in offices and departments of vascular medicine. They will be informed of the study by their physician. If patients agree to take part and meet the eligibility criteria, they will be included consecutively in the study after signing an informed consent form.
The study will include follow-up visits at one week (D7±2, for patients participating in the biological research only), 1 month (D30±5), 3 months (D90±5) and 6 months (D180±5).
At each visit, the following examinations will be carried out:
- Assessment of symptoms and clinical signs to evaluate the Villalta score.
- Venous ultrasound evaluation of the lower limbs by colour Doppler ultrasound (CDUS). Data collected will be useful to calculate the VVI score planned at the study analysis phase.
At the D0, D7, D30 and D90 visits, blood samples will be taken for research purposes to assess factors of inflammation, coagulation and fibrinolysis.
At the D90 and D180 visits, the patient will also be asked to complete the VEINES-QOL and SF-36 quality of life questionnaires.
The patient's participation in the research will end at the end of the D180 visit.
- Conditions
- Postthrombotic Syndrome
- Being tested
- Quantification of deep vein thrombosis burden and assessment of post-thrombotic syndrome
- Keywords
- Venous thrombosis, Thrombus burden, Ultrasonography, Thrombus resolution, Post-thrombotic syndrome
- Medical subject headings
- Postthrombotic Syndrome, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantification of deep vein thrombosis burden and assessment of post-thrombotic syndromeOther
Post-thrombotic syndrome will be assessed by the Villalta score until 6 months of follow-up.
Data collected from colour doppler ultrasound will be used to calculate the Venous Volumetric Index to quantify deep vein thrombosis burden until 6 months of follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Association between thrombosis burden and occurrence of PTS | Experimental | Not described Receives: Other: Quantification of deep vein thrombosis burden and assessment of post-thrombotic syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of moderate to severe Post-thrombotic Syndrome (PTS)
The primary outcome measure is the presence of moderate or severe PTS at 6 months as determined by a Villalta score ≥ 10 or the presence of an ulcer. The Villalta score considers items based on symptoms and clinical signs, including skin complications, each assessed on a scale from 0 to 3. The Villalta score is used to diagnose PTS and categorise its severity, according to international recommendations.
Thrombosis burden is assessed using the VVI index as well as prognostic factors at baseline.
Measured: 6 months
Thrombosis burden
Thrombosis burden is assessed using the Venous Volumetric Index (VVI) as well as prognostic factors at baseline.
Measured: Baseline
Secondary outcomes (7)
Presence of moderate to severe PTS adjusted to other prognostic factors at baseline
PTS is assessed at 6 months by the Villalta scale.
Measured: 6 months
Thrombosis burden adjusted to other prognostic factors at baseline
Thrombosis burden is assessed using the VVI index as well as prognostic factors at baseline.
Measured: Baseline
Presence of moderate to severe PTS adjusted to other prognostic factors at baseline and during follow-up
PTS is assessed at 6 months by the Villalta scale. Other prognostic factors related to anticoagulant therapy and compression are assessed during follow-up.
Measured: Baseline, 1 week, 1 month, 3 months and 6 months
Thrombosis burden adjusted to other prognostic factors at baseline and during follow-up
Thrombosis burden is assessed using the VVI index as well as prognostic factors at baseline.
Other prognostic factors related to anticoagulant therapy and compression are assessed during follow-up.
Measured: Baseline, 1 week, 1 month, 3 months and 6 months
Time to complete resolution of the thrombus as a function of thrombosis burden at baseline
Measured: up to 6 months
Presence of moderate to severe PTS at baseline and at follow-up visits
PTS is assessed by the Villalta scale.
Measured: Baseline, 1 week, 1 month, 3 months and 6 months
Thrombosis burden at baseline and at follow-up visits
The thrombus burden is assessed by the VVI index.
Measured: Baseline, 1 week, 1 month, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start5 Jun 2024
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postthrombotic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Sponsor type
- University, hospital or other
- Collaborators
- Assistance Publique Hopitaux De Marseille, F-CRIN INNOVTE Research Network
- Responsible party
- Sponsor
- Investigators
- Antoine ELIAS, Study director, Centre Hospitalier Intercommunal Toulon La Seyne-sur-Mer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06385353
- Sponsor's protocol ID
- 2022-CHITS-003
- Other IDs
- 2023-A02652-43
- Acronym
- DVT-Burden
- Status last verified
- Jul 2026
- First submitted
- 16 Apr 2024
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 -
- ClinicalTrials.gov ID
- NCT06385353
- Acronym / sponsor ID
- DVT-Burden / 2022-CHITS-003
- Conditions
- Postthrombotic Syndrome
- Keywords
- Venous thrombosis, Thrombus burden, Ultrasonography, Thrombus resolution, Post-thrombotic syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur MerUniversity, hospital or other
- Collaborators
- Assistance Publique Hopitaux De Marseille, F-CRIN INNOVTE Research Network
- Study start
- 5 Jun 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 26 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 first episode of DVT of the lower limbs are recruited in offices and departments of vascular medicine. They will be informed of the study by their physician. If patients agree to take part and meet the eligibility criteria, they will be included consecutively in the study after signing an informed consent form.
The study will include follow-up visits at one week (D7±2, for patients participating in the biological research only), 1 month (D30±5), 3 months (D90±5) and 6 months (D180±5).
At each visit, the following examinations will be carried out:
- Assessment of symptoms and clinical signs to evaluate the Villalta score.
- Venous ultrasound evaluation of the lower limbs by colour Doppler ultrasound (CDUS). Data collected will be useful to calculate the VVI score planned at the study analysis phase.
At the D0, D7, D30 and D90 visits, blood samples will be taken for research purposes to assess factors of inflammation, coagulation and fibrinolysis.
At the D90 and D180 visits, the patient will also be asked to complete the VEINES-QOL and SF-36 quality of life questionnaires.
The patient's participation in the research will end at the end of the D180 visit.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Association between thrombosis burden and occurrence of PTS | Experimental | Other: Quantification of deep vein thrombosis burden and assessment of post-thrombotic syndrome |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quantification of deep vein thrombosis burden and assessment of post-thrombotic syndromePost-thrombotic syndrome will be assessed by the Villalta score until 6 months of follow-up. Data collected from colour doppler ultrasound will be used to calculate the Venous Volumetric Index to quantify deep vein thrombosis burden until 6 months of follow-up. | Other | Association between thrombosis burden and occurrence of PTS |
Primary outcome
Presence of moderate to severe Post-thrombotic Syndrome (PTS)
Time frame: 6 months
The primary outcome measure is the presence of moderate or severe PTS at 6 months as determined by a Villalta score ≥ 10 or the presence of an ulcer. The Villalta score considers items based on symptoms and clinical signs, including skin complications, each assessed on a scale from 0 to 3. The Villalta score is used to diagnose PTS and categorise its severity, according to international recommendations. Thrombosis burden is assessed using the VVI index as well as prognostic factors at baseline.
Thrombosis burden
Time frame: Baseline
Thrombosis burden is assessed using the Venous Volumetric Index (VVI) as well as prognostic factors at baseline.
7 secondary outcomes
Presence of moderate to severe PTS adjusted to other prognostic factors at baseline
Time frame: 6 months
Thrombosis burden adjusted to other prognostic factors at baseline
Time frame: Baseline
Presence of moderate to severe PTS adjusted to other prognostic factors at baseline and during follow-up
Time frame: Baseline, 1 week, 1 month, 3 months and 6 months
Thrombosis burden adjusted to other prognostic factors at baseline and during follow-up
Time frame: Baseline, 1 week, 1 month, 3 months and 6 months
Time to complete resolution of the thrombus as a function of thrombosis burden at baseline
Time frame: up to 6 months
Presence of moderate to severe PTS at baseline and at follow-up visits
Time frame: Baseline, 1 week, 1 month, 3 months and 6 months
Thrombosis burden at baseline and at follow-up visits
Time frame: Baseline, 1 week, 1 month, 3 months and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Antoine ELIAS study director
Centre Hospitalier Intercommunal Toulon La Seyne-sur-Mer
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quantification of deep vein thrombosis burden and assessment of post-thrombotic syndrome in people with Postthrombotic Syndrome, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 27 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Magali CESANA (0483772060, magali.cesana@ch-toulon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of moderate to severe Post-thrombotic Syndrome (PTS) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.