General Practitioner-performed Compression Ultrasound for Deep Vein Thrombosis

Completed

• Conditions: Deep Vein Thrombosis
• Interventions: Other: compression ultrasonography

• Registration Number: NCT02114983
• Lead Sponsor: Azienda Sanitaria Locale ASL 6, Livorno

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-13
• Study First Submitted QC: 2014-04-13
• Study First Posted: 2014-04-15
• Study Start: 2015-01
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-29
• Last Update Posted: 2016-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• first episode of DVT of lower limbs

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
first episode of suspected DVT of the lower limbs	compression ultrasonography	patients with first suspected episode of DVT of the lower limbs

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Azienda USL 6 Livorno; 🇮🇹 Livorno, Tuscany, Italy