General Practitioner-performed Compression Ultrasound for Deep Vein Thrombosis

Study Overview
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Brief Summary
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Numerous studies have demonstrated excellent diagnostic accuracy of Compression Ultrasonography (CUS) performed by hospitals doctors, skilled and unskilled in Radiology. Recently, it was demonstrated that adequately ultrasonography-trained General Practitioners (GP) can perform reliable ultrasound to increase the speed and improve the quality of clinical management of various clinical conditions. To date, in the medical literature there are no studies that demonstrate the diagnostic accuracy of GP in performing CUS for the diagnosis of Deep Vein Thrombosis (DVT). Therefore, we plan to perform a prospective, multicenter, cohort study in which a large number of consecutive outpatients with symptoms or signs of DVT are subject to the CUS by the GP with the aim of evaluating the precision and the diagnostic accuracy compared to specialists in vascular ultrasound, which in this case will be the standard of reference.

Official Title
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Precision and Diagnostic Accuracy of General Practitioner-performed Compression Ultrasound for Proximal Symptomatic Deep Vein Thrombosis

Conditions
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Deep Vein Thrombosis

Intervention / Treatment
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* Other: compression ultrasonography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: first episode of DVT of lower limbs Exclusion Criteria: previous episodes of DVT ongoing anticoagulation age younger than 18 years pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| first episode of suspected DVT of the lower limbs<br>patients with first suspected episode of DVT of the lower limbs | Other: compression ultrasonography<br>* CUS in patients with a high pre-test clinical probability of DVT and/or a positive D-dimer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of General Practitioner in performing CUS for the diagnosis of DVT | Aim of our study is to perform a prospective, multicenter, cohort study in which a large number of consecutive outpatients with symptoms or signs of DVT are subject to the CUS by the General Practitioner with the aim of evaluating the diagnostic accuracy. | Up to 2 h hours after ambulatory admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Precision of CUS performed by General Practitioner for the diagnosis of DVT | The secondary outcome of the study will be the the precision of CUS performed by a doctor of general medicine for the diagnosis of proximal DVT of the lower limbs with respect to the medical specialist in vascular diagnostics, in this case used as a reference. | Up to 2 h hours after ambulatory admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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deep vein thrombosis, diagnostic accuracy, general practitioner, test, compression ultrasonography, ultrasound