Ancillary Study of the ULTREC Project

NCT05300139 | Completed

• 1 other identifier: 2021-CHITS-014
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 12

Brief 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 (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)

Conditions

Deep Vein Thrombosis

Keywords

Deep vein thrombosis; Recurrence; Colour doppler ultrasound; Diagnostic strategy; Outcome

Outcome Measures

Primary Outcomes (1)

• 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.

  90 days

Secondary Outcomes (6)

• Validation of positive DVT criteria by comparison between D30±2 and baseline CDUS

  30 days

• Clinical and Imaging characteristics

  90 days

• Evolution during follow-up

  90 days

• Baseline characteristics for favorable outcome

  1 day

• Venous diameter

  90 days

Study Arms (1)

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.

Other: Color Doppler Ultrasound

Interventions

Color Doppler Ultrasound OTHER

Comparison between D90±5 and baseline CDUS

Also known as: Diagnosis strategy

Patients included in the ULTREC study who had a recurrence of deep vein thrombosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients included in the ULTREC study who had a recurrence of deep vein thrombosis

You may qualify if:

• 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

You may not qualify if:

• Known current pregnancy
• Any condition, which may prevent from performing the colour doppler ultrasound test
• 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

Sponsors & Collaborators

• Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer: lead

Study Sites (12)

Cabinet d'angiologie Cazanave

Carcassonne, Aude, 11000, France

Location

Centre Hospitalier de Carcassonne

Carcassonne, Aude, 11000, France

Location

Cabinet d'angiologie Dias

Martigues, Bouches Du Rhône, 13500, France

Location

Cabinet d'angiologie De Mari

Ajaccio, Corse-du-Sud, 20090, France

Location

Cabinet d'angiologie Secondi

Ajaccio, Corse-du-Sud, 20090, France

Location

Cabinet d'angiologie Cazaux

Auch, Gers, 32000, France

Location

Centre Hospitalier d'Auch

Auch, Gers, 32000, France

Location

Cabinet d'angiologie Bonavita

Bastia, Haute-Corse, 20200, France

Location

Clinique Rive Gauche

Toulouse, Haute-Garonne, 31076, France

Location

Clinique des fleurs

Ollioules, Var, 83140, France

Location

Cabinet d'angiologie Bensedrine

Six-Fours-les-Plages, Var, 83140, France

Location

Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Toulon, Var, 83056, France

Location

Related Publications (5)

• 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.

  PMID: 23682905 BACKGROUND

• 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.

  PMID: 16947316 BACKGROUND

• 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.

  PMID: 22315267 BACKGROUND

• 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.

  PMID: 11790060 BACKGROUND

• 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.

  PMID: 24615063 BACKGROUND

MeSH Terms

Conditions

Venous Thrombosis; Recurrence

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Antoine ELIAS, MD

  Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 29, 2022
• Study Start: November 29, 2021
• Primary Completion: January 24, 2023
• Study Completion: January 24, 2023
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (12)