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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04917328
Other study ID # 8114
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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