Compression Ultrasonography in Non-high Probability of Deep Vein Thrombosis (EPREVUP)

Evaluation of the Predictive Value of Compression Venous Ultrasound by the Emergency Physician for Excluding the Diagnosis of Proximal Deep Vein Thrombosis (DVT) in Patients With Non-high Clinical Pretest Probability

Compression ultrasound is commonly used in emergency department. Accuracy to rule out deep vein thrombosis is excellent but lower then Ddimer assessment which is actually gold standard. With progress in formation of emergency physicians (EP), quality of material used, the investigators hypothesize that compression ultrasound can rule out deep vein thrombosis in case of non high probability, as standard care and DDimer assay.

Study Overview

• Status: Recruiting
• Conditions: Deep Vein Thrombosis
• Intervention / Treatment: Other: compression ultrasound

• Study Type: Interventional
• Enrollment (Estimated): 700
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pierrick LE BORGNE, MD; Phone Number: 03.88.12.86.90; Email: pierrick.leborgne@chru-strasbourg.fr
• Study Contact Backup: Name: Mathieu OBERLIN, MD; Phone Number: 03.88.12.79.85; Email: mathieu.oberlin@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg, France
    • Recruiting
    • CHU Strasbourg
    • Contact: Pierrick LE BORGNE, MD; Phone Number: 0388128690; Email: pierrick.leborgne@chru-strasbourg.fr
    • Contact: Mathieu OBERLIN; Phone Number: 0388127985; Email: mathieu.oberlin@chru-strasbourg.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• adult patient
• Patient presenting to the emergency department with clinical suspicion of DVT (i.e. pain and/or lower extremity edema).
• Patient with a non-high probability according to the modified Wells score, i.e. a score of 0 or 1
• Subject with a social health insurance plan
• Subject able to understand the objectives and risks of the research and to give a signed and dated informed consent

Exclusion Criteria:

• Patient with suspected pulmonary embolism
• Patient with a high probability of DVT
• Impossible to perform a whole leg doppler ultrasound within 5 days
• Pregnant or breast-feeding woman, on patient's declaration
• Subject under court protection
• Subject under guardianship or curatorship

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient with clinical suspicion of deep vein thrombosis	Other: compression ultrasound; performing a compression ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Negative predictive value of compression ultrasound for diagnosis of deep vein thrombosis	The measurement is assessed during ED stay or in 5 days if DD is positive with no DVT in compression ultrasound

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2022
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: June 1, 2021
• First Submitted That Met QC Criteria: June 1, 2021
• First Posted (Actual): June 8, 2021

Study Record Updates

• Last Update Posted (Actual): August 3, 2025
• Last Update Submitted That Met QC Criteria: August 1, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis
• Other Study ID Numbers: 8114

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No