Ancillary Study of the ULTREC Project (ULTRECAncillar)

Intermunicipal Hospital Center Toulon

Status: Completed

Conditions: Deep Vein Thrombosis

Treatments: Other: Color Doppler Ultrasound

Study type: Observational

Funder types: Other

Identifiers

NCT05300139

2021-CHITS-014

Details and patient eligibility

About

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)

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

18 participants in 1 patient group

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

Description:

Patients who have a baseline CDUS diagnosis of recurrent DVT as identified in the ULTREC study.

Treatment:

Other: Color Doppler Ultrasound