Deep Vein ThrombosisULTRECAncillarNCT05300139
Ancillary Study of the ULTREC Project
An observational study of Deep Vein Thrombosis, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 12 sites in France.
Trial summary
The ULTREC research project is designed to assess the safety of a negative strategy relying on Colour Doppler Ultrasound (CDUS) for excluding the diagnosis of a new thrombosis. The ULTREC project does not take into account the validity of the CDUS positive criteria used to confirm the diagnosis of Deep Vein Thrombosis… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Vein Thrombosis
- What is being tested?
- Color Doppler Ultrasound
- How many people
- 18 participants
- Where
- 12 sitesFrance
- Study dates
- 29 Nov 2021to 24 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients included in the ULTREC study who had a recurrence of deep vein thrombosis
Who may be able to join
- Age ≥ 18 years
- Known history of objectively documented deep vein thrombosis of the lower limb (with or without pulmonary embolism)
- Out-patients referred for clinically suspected acute recurrent ipsilateral DVT of the lower limb
- Patients covered by social security or an equivalent regimen
- No objection to the use of the data
- Inclusion in the ULTREC study
Who cannot join
- Known current pregnancy
- Any condition, which may prevent from performing the colour doppler ultrasound test
- Delay from onset of symptoms to inclusion of more than 10 days
- Therapeutic anticoagulation for more than 48 hours in the two days prior to consent to ULTREC Study
- Presence of clinical symptoms or signs of pulmonary embolism
- Life expectancy less than 3 months
- Patient unable to adhere to ULTREC protocol follow-up
- Participants under judicial protection or incapacity
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
Cabinet d'angiologie De Mari
Ajaccio, Corse-du-Sud, 20090
Cabinet d'angiologie Secondi
Ajaccio, Corse-du-Sud, 20090
Cabinet d'angiologie Cazaux
Auch, Gers, 32000
Centre Hospitalier d'Auch
Auch, Gers, 32000
Cabinet d'angiologie Bonavita
Bastia, Haute-Corse, 20200
Cabinet d'angiologie Cazanave
Carcassonne, Aude, 11000
Centre Hospitalier de Carcassonne
Carcassonne, Aude, 11000
Cabinet d'angiologie Dias
Martigues, Bouches Du Rhône, 13500
Clinique des fleurs
Ollioules, Var, 83140
Cabinet d'angiologie Bensedrine
Six-Fours-les-Plages, Var, 83140
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
Toulon, Var, 83056
Clinique Rive Gauche
Toulouse, Haute-Garonne, 31076
About this study
Official title: Validation of Ultrasonic Positive Diagnosis Criteria of Ipsilateral Deep Vein Thrombosis Recurrence of the Lower Limbs Based on Thrombosis Evolution at a 3-month Follow-up Under Anticoagulation: The ULTREC Project Ancillary Study
The ULTREC research project is designed to assess the safety of a negative strategy relying on Colour Doppler Ultrasound (CDUS) for excluding the diagnosis of a new thrombosis. The ULTREC project does not take into account the validity of the CDUS positive criteria used to confirm the diagnosis of Deep Vein Thrombosis (DVT) recurrence.
The risk of considering only the negative strategy is to ignore the possibility of having an improvement in sensitivity and negative predictive value at the expense of specificity and positive predictive value and therefore to increase the false positive rate leading to an overdiagnosis of recurrence and an overtreatment, and a potential bleeding risk.
Read more
In the ULTREC-ANCILLARY study, the research will aim at assessing the validity of baseline CDUS positive criteria for the diagnosis of DVT recurrence. As there is no diagnostic standard to which the results could be compared, it is suggested to validate these criteria based on the evolution of the thrombosis on CDUS performed at D90±5.
The hypothesis is that an unchanged appearance under anticoagulation would be in favor of sequelae and will invalidate the initial diagnosis (diagnostic failure)
- Conditions
- Deep Vein Thrombosis
- Being tested
- Color Doppler Ultrasound
- Keywords
- Deep vein thrombosis, Recurrence, Colour doppler ultrasound, Diagnostic strategy, Outcome
- Medical subject headings
- Venous Thrombosis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Color Doppler UltrasoundOther
Also called Diagnosis strategy
Comparison between D90±5 and baseline CDUS
| Study group | Role | What they receive |
|---|---|---|
| Patients included in the ULTREC study who had a recurrence of deep vein thrombosis | Patients who have a baseline CDUS diagnosis of recurrent DVT as identified in the ULTREC study. Receives: Other: Color Doppler Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the thrombosis at D90±5
Failure rate judged on the stable aspect of the thrombosis at D90±5 defined by the absence of change in the obstruction and the extent of the thrombosis and the absence of change in the venous diameter under compression (no increase or increase < 4 mm). Vein diameter is measured under compression by ultrasound in a cross-sectional view from the external wall to the external wall of the vein segment.
Measured: 90 days
Secondary outcomes (6)
Validation of positive DVT criteria by comparison between D30±2 and baseline CDUS
Failure rate judged on the stable aspect of the thrombosis at D30±2 defined by the absence of change in the obstruction and the extent of the thrombosis and the absence of change in the venous diameter under compression (no increase or increase < 4 mm)
Measured: 30 days
Clinical and Imaging characteristics
Comparison of clinical and CDUS imaging characteristics between day-0 and day-90 visits
Measured: 90 days
Evolution during follow-up
Rate of worsening, stabilization and improvement (regression, normalization) Worsening is defined by : a transition from partial obstruction to complete occlusion of a vein segment, an increase ≥ 4 mm in vein diameter measurement or progression of thrombus to another vein segment.
Stabilization is defined by : an unchanged pattern. Improvement (regression, normalization) is defined by : a transition from a complete occlusion to a partial obstruction or normalization of the vein segment.
Measured: 90 days
Baseline characteristics for favorable outcome
Imaging and clinical characteristics of thrombus at Day-0 visit
Measured: 1 day
Venous diameter
Evolution of venous diameter at day-90 as measured under compression by ultrasound in a cross-sectional view from the external wall to the external wall of the vein segment
Measured: 90 days
Diagnosis of individual characteristics of DVT recurrence
Failure rate related to the baseline measurement of vein diameter and ULTREC diagnostic recurrence positivity criteria (defined as an occlusive thrombus or a partially obstructive thrombus without reflux, or a free-floating thrombus).
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start29 Nov 2021
- Primary completion24 Jan 2023
- Study completion24 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Deep Vein ThrombosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine ELIAS, MD, Study director, Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05300139
- Sponsor's protocol ID
- 2021-CHITS-014
- Acronym
- ULTRECAncillar
- Status last verified
- Jul 2026
- First submitted
- 3 Mar 2022
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ageno W, Squizzato A, Wells PS, Buller HR, Johnson G. The diagnosis of symptomatic recurrent pulmonary embolism and deep vein thrombosis: guidance from the SSC of the ISTH. J Thromb Haemost. 2013 Aug;11(8):1597-602. doi: 10.1111/jth.12301. No abstract available.
PubMed 23682905Aguilar C, del Villar V. Combined D-dimer and clinical probability are useful for exclusion of recurrent deep venous thrombosis. Am J Hematol. 2007 Jan;82(1):41-4. doi: 10.1002/ajh.20754.
PubMed 16947316Bates SM, Jaeschke R, Stevens SM, Goodacre S, Wells PS, Stevenson MD, Kearon C, Schunemann HJ, Crowther M, Pauker SG, Makdissi R, Guyatt GH. Diagnosis of DVT: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e351S-e418S. doi: 10.1378/chest.11-2299.
PubMed 22315267Fraser DG, Moody AR, Morgan PS, Martel AL, Davidson I. Diagnosis of lower-limb deep venous thrombosis: a prospective blinded study of magnetic resonance direct thrombus imaging. Ann Intern Med. 2002 Jan 15;136(2):89-98. doi: 10.7326/0003-4819-136-2-200201150-00006.
PubMed 11790060Geersing GJ, Zuithoff NP, Kearon C, Anderson DR, Ten Cate-Hoek AJ, Elf JL, Bates SM, Hoes AW, Kraaijenhagen RA, Oudega R, Schutgens RE, Stevens SM, Woller SC, Wells PS, Moons KG. Exclusion of deep vein thrombosis using the Wells rule in clinically important subgroups: individual patient data meta-analysis. BMJ. 2014 Mar 10;348:g1340. doi: 10.1136/bmj.g1340.
PubMed 24615063
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
- Validation of Ultrasonic Positive Diagnosis Criteria of Ipsilateral Deep Vein Thrombosis Recurrence of the Lower Limbs Based on Thrombosis Evolution at a 3-month Follow-up Under Anticoagulation: The ULTREC Project Ancillary Study
- ClinicalTrials.gov ID
- NCT05300139
- Acronym / sponsor ID
- ULTRECAncillar / 2021-CHITS-014
- Conditions
- Deep Vein Thrombosis
- Keywords
- Deep vein thrombosis, Recurrence, Colour doppler ultrasound, Diagnostic strategy, Outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur MerUniversity, hospital or other
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- 24 Jan 2023 (actual)
- Study completion
- 24 Jan 2023 (actual)
- First posted
- 29 Mar 2022 (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.
The ULTREC research project is designed to assess the safety of a negative strategy relying on Colour Doppler Ultrasound (CDUS) for excluding the diagnosis of a new thrombosis. The ULTREC project does not take into account the validity of the CDUS positive criteria used to confirm the diagnosis of Deep Vein Thrombosis (DVT) recurrence.
The risk of considering only the negative strategy is to ignore the possibility of having an improvement in sensitivity and negative predictive value at the expense of specificity and positive predictive value and therefore to increase the false positive rate leading to an overdiagnosis of recurrence and an overtreatment, and a potential bleeding risk.
In the ULTREC-ANCILLARY study, the research will aim at assessing the validity of baseline CDUS positive criteria for the diagnosis of DVT recurrence. As there is no diagnostic standard to which the results could be compared, it is suggested to validate these criteria based on the evolution of the thrombosis on CDUS performed at D90±5.
The hypothesis is that an unchanged appearance under anticoagulation would be in favor of sequelae and will invalidate the initial diagnosis (diagnostic failure)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients included in the ULTREC study who had a recurrence of deep vein thrombosis | – | Other: Color Doppler UltrasoundPatients who have a baseline CDUS diagnosis of recurrent DVT as identified in the ULTREC study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients included in the ULTREC study who had a recurrence of deep vein thrombosis
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Known history of objectively documented deep vein thrombosis of the lower limb (with or without pulmonary embolism)
- Out-patients referred for clinically suspected acute recurrent ipsilateral DVT of the lower limb
- Patients covered by social security or an equivalent regimen
- No objection to the use of the data
Key exclusion criteria (8 listed)
- Known current pregnancy
- Any condition, which may prevent from performing the colour doppler ultrasound test
- Delay from onset of symptoms to inclusion of more than 10 days
- Therapeutic anticoagulation for more than 48 hours in the two days prior to consent to ULTREC Study
- Presence of clinical symptoms or signs of pulmonary embolism
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 |
|---|---|---|
| Color Doppler UltrasoundAlso: Diagnosis strategyComparison between D90±5 and baseline CDUS | Other | Patients included in the ULTREC study who had a recurrence of deep vein thrombosis |
Primary outcome
Evolution of the thrombosis at D90±5
Time frame: 90 days
Failure rate judged on the stable aspect of the thrombosis at D90±5 defined by the absence of change in the obstruction and the extent of the thrombosis and the absence of change in the venous diameter under compression (no increase or increase < 4 mm). Vein diameter is measured under compression by ultrasound in a cross-sectional view from the external wall to the external wall of the vein segment.
6 secondary outcomes
Validation of positive DVT criteria by comparison between D30±2 and baseline CDUS
Time frame: 30 days
Clinical and Imaging characteristics
Time frame: 90 days
Evolution during follow-up
Time frame: 90 days
Baseline characteristics for favorable outcome
Time frame: 1 day
Venous diameter
Time frame: 90 days
Diagnosis of individual characteristics of DVT recurrence
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Background: PubMed 23682905Ageno W, Squizzato A, Wells PS, Buller HR, Johnson G. The diagnosis of symptomatic recurrent pulmonary embolism and deep vein thrombosis: guidance from the SSC of the ISTH. J Thromb Haemost. 2013 Aug;11(8):1597-602. doi: 10.1111/jth.12301. No abstract available.
- Background: PubMed 16947316Aguilar C, del Villar V. Combined D-dimer and clinical probability are useful for exclusion of recurrent deep venous thrombosis. Am J Hematol. 2007 Jan;82(1):41-4. doi: 10.1002/ajh.20754.
- Background: PubMed 22315267Bates SM, Jaeschke R, Stevens SM, Goodacre S, Wells PS, Stevenson MD, Kearon C, Schunemann HJ, Crowther M, Pauker SG, Makdissi R, Guyatt GH. Diagnosis of DVT: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e351S-e418S. doi: 10.1378/chest.11-2299.
- Background: PubMed 11790060Fraser DG, Moody AR, Morgan PS, Martel AL, Davidson I. Diagnosis of lower-limb deep venous thrombosis: a prospective blinded study of magnetic resonance direct thrombus imaging. Ann Intern Med. 2002 Jan 15;136(2):89-98. doi: 10.7326/0003-4819-136-2-200201150-00006.
- Background: PubMed 24615063Geersing GJ, Zuithoff NP, Kearon C, Anderson DR, Ten Cate-Hoek AJ, Elf JL, Bates SM, Hoes AW, Kraaijenhagen RA, Oudega R, Schutgens RE, Stevens SM, Woller SC, Wells PS, Moons KG. Exclusion of deep vein thrombosis using the Wells rule in clinically important subgroups: individual patient data meta-analysis. BMJ. 2014 Mar 10;348:g1340. doi: 10.1136/bmj.g1340.
- 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. This study is not recruiting at the moment.
Antoine ELIAS, MD study director
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deep Vein Thrombosis, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 12 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 6 inclusion and 8 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: finished, 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 12 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of the thrombosis at D90±5 (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05300139, which also lists 5 linked publications.
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.