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Completed

NCT Number: NCT05300139

Ancillary Study of the ULTREC Project

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)

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Key information

Conditions

Deep Vein Thrombosis Cardiovascular Diseases Disease Attributes Embolism and Thrombosis Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cabinet d'angiologie Cazanave, Carcassonne, Aude, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Color Doppler Ultrasound

Other

Comparison between D90±5 and baseline CDUS

Other names: Diagnosis strategy

Primary outcomes

  1. Evolution of the thrombosis at D90±5

    Time frame: 90 days

    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.

Secondary outcomes

  1. Validation of positive DVT criteria by comparison between D30±2 and baseline CDUS

    Time frame: 30 days

    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)

  2. Clinical and Imaging characteristics

    Time frame: 90 days

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

  3. Evolution during follow-up

    Time frame: 90 days

    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.

  4. Baseline characteristics for favorable outcome

    Time frame: 1 day

    Imaging and clinical characteristics of thrombus at Day-0 visit

  5. Venous diameter

    Time frame: 90 days

    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

  6. Diagnosis of individual characteristics of DVT recurrence

    Time frame: 90 days

    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).

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Other

Registry information

Official study 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

Acronym: ULTRECAncillar

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 29, 2022
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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