Ancillary Study of the ULTREC Project (NCT05300139) | Clinical Trial Compass
CompletedNot Applicable
Ancillary Study of the ULTREC Project
France18 participantsStarted 2021-11-29
Plain-language 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)
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
✓. Inclusion in the ULTREC study
Exclusion criteria
✕. Known current pregnancy
✕. Any condition, which may prevent from performing the colour doppler ultrasound test
✕. Delay from onset of symptoms to inclusion of more than 10 days
✕. Therapeutic anticoagulation for more than 48 hours in the two days prior to consent to ULTREC Study
What they're measuring
1
Evolution of the thrombosis at D90±5
Timeframe: 90 days
Trial details
NCT IDNCT05300139
SponsorCentre Hospitalier Intercommunal de Toulon La Seyne sur Mer