Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID04917328

Evaluation of Compression Ultrasound by Emergency Physicians to Exclude Proximal Deep Vein Thrombosis in Patients With Low Clinical Probability

Led by University Hospital, Strasbourg, France · Updated on 2025-08-03

700

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of compression ultrasound performed by emergency physicians to exclude the diagnosis of proximal deep vein thrombosis (DVT) in patients with a low clinical probability of having DVT. The study aims to compare the accuracy of compression ultrasound to the D-Dimer assay, which is considered the gold standard, especially for patients with non-high clinical pretest probability. This investigation is sponsored by University Hospital, Strasbourg, France. Participants with clinical suspicion of DVT and a non-high probability score based on the modified Wells criteria will undergo compression ultrasound during their emergency department visit. The ultrasound will be performed as standard care to assess its predictive value in ruling out DVT. If the D-Dimer test is positive, a follow-up whole leg Doppler ultrasound will be done within 5 days. Throughout the study, researchers will monitor the negative predictive value of compression ultrasound to confirm the absence of DVT either during the emergency stay or within the 5-day follow-up for those with positive D-Dimer results. Participants will provide informed consent and be assessed for eligibility based on clinical criteria. The total study duration extends until February 2027, with continuous evaluation of ultrasound accuracy and safety in this setting.

CONDITIONS

Brief Title

Compression Ultrasonography in Non-high Probability of Deep Vein Thrombosis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patient
  • Patient presenting to the emergency department with clinical suspicion of deep vein thrombosis (pain and/or lower extremity swelling)
  • Non-high probability for DVT based on modified Wells score (score of 0 or 1)
  • Has social health insurance
  • Able to understand study objectives and risks and provide signed informed consent
Not Eligible

You will not qualify if you...

  • Suspected pulmonary embolism
  • High clinical probability of deep vein thrombosis
  • Unable to perform whole leg Doppler ultrasound within 5 days
  • Pregnant or breastfeeding woman
  • Under court protection
  • Under guardianship or curatorship

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - During emergency department stay or up to 5 days if initial assessment is positive

Participants undergo compression ultrasound performed by emergency physicians to evaluate for deep vein thrombosis.

1 visit during emergency department stay, with possible follow-up within 5 days

Trial Site Locations

Total: 1 location

1

CHU Strasbourg

Strasbourg, France

Actively Recruiting

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Research Team

P

Pierrick LE BORGNE, MD

M

Mathieu OBERLIN, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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