General Practitioner-performed Compression Ultrasound for Deep Vein Thrombosis

Deep Vein Thrombosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02114983
• Other study ID #: MN-1
• Status: Completed
• Phase: N/A
• First received: April 13, 2014
• Last updated: May 29, 2016
• Start date: January 2015
• Est. completion date: March 2016

Study information

• Verified date: May 2016
• Source: Azienda Sanitaria Locale ASL 6, Livorno
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Azienda Sanitaria Locale ASL 6 Livorno
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

Other:
• compression ultrasonography
CUS in patients with a high pre-test clinical probability of DVT and/or a positive D-dimer

Locations

Country	Name	City	State
Italy	Azienda USL 6 Livorno	Livorno	Tuscany

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Sanitaria Locale ASL 6, Livorno

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	No
Secondary	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	No