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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
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Deep Vein Thrombosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
June 1, 2021
Last Updated
August 18, 2023
Sponsor
University Hospital, Strasbourg, France
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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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