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 (ULTRECAncillar)

  • STATUS
    Recruiting
  • days left to enroll
    46
  • participants needed
    90
  • sponsor
    Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Updated on 24 October 2022
clot
deep vein thrombosis
doppler ultrasound
embolism
deep venous thrombosis of lower extremity

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)

Details
Condition Deep Vein Thrombosis
Treatment color Doppler ultrasound
Clinical Study IdentifierNCT05300139
SponsorCentre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Last Modified on24 October 2022

Eligibility

Yes No Not Sure

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
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
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