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出境医 / 临床实验 / Compression Ultrasonography in Non-high Probability of Deep Vein Thrombosis (EPREVUP)

Compression Ultrasonography in Non-high Probability of Deep Vein Thrombosis (EPREVUP)

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.

Condition or disease Intervention/treatment Phase
Deep Vein Thrombosis Other: compression ultrasound Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Estimated Study Start Date : December 1, 2022
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : September 8, 2024
Arms and Interventions
Arm Intervention/treatment
Experimental: Patient with clinical suspicion of deep vein thrombosis Other: compression ultrasound
performing a compression ultrasound
Outcome Measures
Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Pierrick LE BORGNE, MD 03.88.12.86.90 pierrick.leborgne@chru-strasbourg.fr
Contact: Mathieu OBERLIN, MD 03.88.12.79.85 mathieu.oberlin@chru-strasbourg.fr

Locations
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France
CHU Strasbourg
Strasbourg, France
Contact: Pierrick LE BORGNE, MD    0388128690    pierrick.leborgne@chru-strasbourg.fr   
Contact: Mathieu OBERLIN    0388127985    mathieu.oberlin@chru-strasbourg.fr   
Sponsors and Collaborators
University Hospital, Strasbourg, France
Tracking Information
First Submitted Date  ICMJE June 1, 2021
First Posted Date  ICMJE June 8, 2021
Last Update Posted Date November 24, 2021
Estimated Study Start Date  ICMJE December 1, 2022
Estimated Primary Completion Date December 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2021) 		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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Compression Ultrasonography in Non-high Probability of Deep Vein Thrombosis
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Deep Vein Thrombosis
Intervention  ICMJE Other: compression ultrasound
performing a compression ultrasound
Study Arms  ICMJE Experimental: Patient with clinical suspicion of deep vein thrombosis
Intervention: Other: compression ultrasound
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 1, 2021) 		700
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 8, 2024
Estimated Primary Completion Date December 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pierrick LE BORGNE, MD 03.88.12.86.90 pierrick.leborgne@chru-strasbourg.fr
Contact: Mathieu OBERLIN, MD 03.88.12.79.85 mathieu.oberlin@chru-strasbourg.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04917328
Other Study ID Numbers  ICMJE 8114
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Strasbourg, France
Study Sponsor  ICMJE University Hospital, Strasbourg, France
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital, Strasbourg, France
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP