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

Azienda Sanitaria Locale ASL 6, Livorno1 site in 1 country1,000 target enrollmentJanuary 2015

ConditionsDeep Vein Thrombosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Deep Vein Thrombosis
Sponsor: Azienda Sanitaria Locale ASL 6, Livorno
Enrollment: 1000
Locations: 1
Primary Endpoint: Diagnostic accuracy of General Practitioner in performing CUS for the diagnosis of DVT
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 2015

End Date

March 2016

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Azienda Sanitaria Locale ASL 6, Livorno

Responsible Party

Principal Investigator

Nicola Mumoli

Dr Nicola Mumoli, M.D.

Azienda Sanitaria Locale ASL 6, Livorno

Eligibility Criteria

Inclusion Criteria

•first episode of DVT of lower limbs

Exclusion Criteria

•previous episodes of DVT
•ongoing anticoagulation
•age younger than 18 years
•pregnancy

Outcomes

Primary Outcomes

Diagnostic accuracy of General Practitioner in performing CUS for the diagnosis of DVT

Time Frame: Up to 2 h hours after ambulatory admission

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.