Compression Ultrasonography in Non-high Probability of Deep Vein Thrombosis

Deep Vein Thrombosis Clinical Trial

— EPREVUP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04917328
• Other study ID #: 8114
• Status: Recruiting
• Phase: N/A
• Start date: February 21, 2022
• Est. completion date: February 28, 2025

Study information

• Verified date: August 2023
• Source: University Hospital, Strasbourg, France
• Contact: Pierrick LE BORGNE, MD
• Phone: 03.88.12.86.90
• Email: pierrick.leborgne[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: February 28, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

Other:
• compression ultrasound
performing a compression ultrasound

Locations

Country	Name	City	State
France	CHU Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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