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Recruiting NCT04917328

Compression Ultrasonography in Non-high Probability of Deep Vein Thrombosis

No phase Interventional Deep Vein Thrombosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: compression ultrasound.
Who it may be relevant to
Registry conditions: Deep Vein Thrombosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Interventions

  • Other compression ultrasound
    performing a compression ultrasound

Primary outcome measures

  • 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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 1 center
  • CHU Strasbourg — Strasbourg

Identifiers

NCT: NCT04917328 · 8114

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗