Ancillary Study of the ULTREC Project

Deep Vein Thrombosis Clinical Trial

— ULTRECAncillar  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05300139
• Other study ID #: 2021-CHITS-014
• Status: Completed
• Start date: November 29, 2021
• Est. completion date: January 24, 2023

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 (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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 24, 2023
• Est. primary completion date: January 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age = 18 years

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:

1. Known current pregnancy

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

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

Other:
• Color Doppler Ultrasound
Comparison between D90±5 and baseline CDUS

Locations

Country	Name	City	State
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	Cabinet d'angiologie Cazanave	Carcassonne	Aude
France	Centre Hospitalier de Carcassonne	Carcassonne	Aude
France	Cabinet d'angiologie Dias	Martigues	Bouches Du Rhône
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	Clinique Rive Gauche	Toulouse	Haute-Garonne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Country where clinical trial is conducted

France, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	30 days
Secondary	Clinical and Imaging characteristics	Comparison of clinical and CDUS imaging characteristics between day-0 and day-90 visits	90 days
Secondary	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.	90 days
Secondary	Baseline characteristics for favorable outcome	Imaging and clinical characteristics of thrombus at Day-0 visit	1 day
Secondary	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	90 days
Secondary	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).	90 days