Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
18 participants
OBSERVATIONAL
2021-11-29
2023-01-24
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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)
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The ERASMUS Study: Limited vs Extended US for DVT Diagnosis
NCT00353093
Compression Ultrasonography in Non-high Probability of Deep Vein Thrombosis
NCT04917328
Diagnostic Performance of General Practitioners in Compression UltraSound
NCT05550038
Simplification of the Diagnosis of Deep Vein Thrombosis
NCT01412242
Location of Lower Extremity Deep Vein Thrombosis by Emergency Physicians Using Portable Compression Ultrasonography
NCT02262494
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Color Doppler Ultrasound
Comparison between D90±5 and baseline CDUS
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Color Doppler Ultrasound
Comparison between D90±5 and baseline CDUS
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Known history of objectively documented deep vein thrombosis of the lower limb (with or without pulmonary embolism)
3. Out-patients referred for clinically suspected acute recurrent ipsilateral DVT of the lower limb
4. Patients covered by social security or an equivalent regimen
5. No objection to the use of the data
6. Inclusion in the ULTREC study
Exclusion Criteria
2. Any condition, which may prevent from performing the colour doppler ultrasound test
3. Delay from onset of symptoms to inclusion of more than 10 days
4. Therapeutic anticoagulation for more than 48 hours in the two days prior to consent to ULTREC Study
5. Presence of clinical symptoms or signs of pulmonary embolism
6. Life expectancy less than 3 months
7. Patient unable to adhere to ULTREC protocol follow-up
8. Participants under judicial protection or incapacity
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Antoine ELIAS, MD
Role: STUDY_DIRECTOR
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cabinet d'angiologie Cazanave
Carcassonne, Aude, France
Centre Hospitalier de Carcassonne
Carcassonne, Aude, France
Cabinet d'angiologie Dias
Martigues, Bouches Du Rhône, France
Cabinet d'angiologie De Mari
Ajaccio, Corse-du-Sud, France
Cabinet d'angiologie Secondi
Ajaccio, Corse-du-Sud, France
Cabinet d'angiologie Cazaux
Auch, Gers, France
Centre Hospitalier d'Auch
Auch, Gers, France
Cabinet d'angiologie Bonavita
Bastia, Haute-Corse, France
Clinique Rive Gauche
Toulouse, Haute-Garonne, France
Clinique des fleurs
Ollioules, Var, France
Cabinet d'angiologie Bensedrine
Six-Fours-les-Plages, Var, France
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
Toulon, Var, France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Aguilar 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.
Bates 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.
Fraser 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.
Geersing 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2021-CHITS-014
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.