Ancillary Study of the ULTREC Project

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer18 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Deep Vein Thrombosis

Interventions

Color Doppler Ultrasound

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (12)

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

...and 2 more locations

Outcomes

Primary Outcomes

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.

Time frame: 90 days

Secondary Outcomes

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)

Time frame: 30 days

Clinical and Imaging characteristics

Comparison of clinical and CDUS imaging characteristics between day-0 and day-90 visits

Time frame: 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.

Time frame: 90 days

Baseline characteristics for favorable outcome

Imaging and clinical characteristics of thrombus at Day-0 visit

Time frame: 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

Time frame: 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).

Time frame: 90 days