Compression Ultrasonography in Non-high Probability of Deep Vein Thrombosis

Not Applicable

Recruiting

• Conditions: Deep Vein Thrombosis
• Interventions: Other: compression ultrasound

• Registration Number: NCT04917328
• Lead Sponsor: University Hospital, Strasbourg, France

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-01
• Study First Submitted QC: 2021-06-01
• Study First Posted: 2021-06-08
• Study Start: 2022-02-21
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-16
• Last Update Posted: 2024-08-19
• Primary Completion: 2025-02-28
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 700

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient with clinical suspicion of deep vein thrombosis	compression ultrasound	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CHU Strasbourg; 🇫🇷 Strasbourg, France