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Ancillary Study of the ULTREC Project

NCT05300139 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 18

Last updated 2026-04-13

No results posted yet for this study

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)

Conditions

  • Deep Vein Thrombosis

Interventions

OTHER

Color Doppler Ultrasound

Comparison between D90±5 and baseline CDUS

Sponsors & Collaborators

  • Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

    lead OTHER

Principal Investigators

  • Antoine ELIAS, MD · Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-29
Primary Completion
2023-01-24
Completion
2023-01-24

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05300139 on ClinicalTrials.gov