Compression Ultrasonography in Non-high Probability of Deep Vein Thrombosis (EPREVUP)
Primary Purpose
Deep Vein Thrombosis
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
compression ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Deep Vein Thrombosis
Eligibility Criteria
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
Sites / Locations
- CHU StrasbourgRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patient with clinical suspicion of deep vein thrombosis
Arm Description
Outcomes
Primary Outcome Measures
Negative predictive value of compression ultrasound for diagnosis of deep vein thrombosis
Secondary Outcome Measures
Full Information
NCT ID
NCT04917328
First Posted
June 1, 2021
Last Updated
August 18, 2023
Sponsor
University Hospital, Strasbourg, France
1. Study Identification
Unique Protocol Identification Number
NCT04917328
Brief Title
Compression Ultrasonography in Non-high Probability of Deep Vein Thrombosis
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 21, 2022 (Actual)
Primary Completion Date
February 28, 2025 (Anticipated)
Study Completion Date
February 28, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Vein Thrombosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
700 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patient with clinical suspicion of deep vein thrombosis
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
compression ultrasound
Intervention Description
performing a compression ultrasound
Primary Outcome Measure Information:
Title
Negative predictive value of compression ultrasound for diagnosis of deep vein thrombosis
Time Frame
The measurement is assessed during ED stay or in 5 days if DD is positive with no DVT in compression ultrasound
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pierrick LE BORGNE, MD
Phone
03.88.12.86.90
Email
pierrick.leborgne@chru-strasbourg.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Mathieu OBERLIN, MD
Phone
03.88.12.79.85
Email
mathieu.oberlin@chru-strasbourg.fr
Facility Information:
Facility Name
CHU Strasbourg
City
Strasbourg
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierrick LE BORGNE, MD
Phone
0388128690
Email
pierrick.leborgne@chru-strasbourg.fr
First Name & Middle Initial & Last Name & Degree
Mathieu OBERLIN
Phone
0388127985
Email
mathieu.oberlin@chru-strasbourg.fr
12. IPD Sharing Statement
Learn more about this trial
Compression Ultrasonography in Non-high Probability of Deep Vein Thrombosis
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