NCT04917328

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Feb 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Feb 2022Feb 2027

First Submitted

Initial submission to the registry

June 1, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 8, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

February 21, 2022

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

August 3, 2025

Status Verified

August 1, 2025

Enrollment Period

5 years

First QC Date

June 1, 2021

Last Update Submit

August 1, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Patient with clinical suspicion of deep vein thrombosis

EXPERIMENTAL
Other: compression ultrasound

Interventions

performing a compression ultrasound

Patient with clinical suspicion of deep vein thrombosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Strasbourg

Strasbourg, France

RECRUITING

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2021

First Posted

June 8, 2021

Study Start

February 21, 2022

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

February 28, 2027

Last Updated

August 3, 2025

Record last verified: 2025-08

Locations