General Practitioner-performed Compression Ultrasound for Deep Vein Thrombosis

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02114983

Enrollment

1000

Registered

2014-04-15

Start date

2015-01-31

Completion date

2016-03-31

Last updated

2016-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Vein Thrombosis

Keywords

deep vein thrombosis, diagnostic accuracy, general practitioner, test, compression ultrasonography, ultrasound

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.

Interventions

OTHERcompression ultrasonography

CUS in patients with a high pre-test clinical probability of DVT and/or a positive D-dimer

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* first episode of DVT of lower limbs

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic accuracy of General Practitioner in performing CUS for the diagnosis of DVT	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.

Secondary

Measure	Time frame	Description
Precision of CUS performed by General Practitioner for the diagnosis of DVT	Up to 2 h hours after ambulatory admission	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.

Other

Measure	Time frame
To assess the prevalence of DVT in patients with a high pre-test probability and/or a positive D-dimer	Up to 2 h hours after ambulatory admission

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026