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

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.

Study Overview

• Status: Completed
• Conditions: Deep Vein Thrombosis
• Intervention / Treatment: Other: compression ultrasonography

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• Italy
  • Tuscany
    • Livorno, Tuscany, Italy, 57100
      • Azienda USL 6 Livorno

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All outpatients evaluated at home or at office by the GP with a first episode of suspected DVT of the lower limbs will be screened with CUS. GP may use his/her own ultrasound, or take advantage of the equipment of the Vascular Service of the Hospital. Shortly afterward, (i.e., within 2 hours), all outpatients will be re-evaluated by a doctor with expertize in vascular ultrasound

Description

Inclusion Criteria:

• first episode of DVT of lower limbs

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
first episode of suspected DVT of the lower limbs; patients with first suspected episode of DVT of the lower limbs	Other: compression ultrasonography; CUS in patients with a high pre-test clinical probability of DVT and/or a positive D-dimer

What is the study measuring?

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

Other Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Azienda Sanitaria Locale ASL 6, Livorno
• Investigators: Principal Investigator: Nicola Mumoli, MD, Section of Vascular Medicine - Livorno Hospital, Italy

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: April 13, 2014
• First Submitted That Met QC Criteria: April 13, 2014
• First Posted (Estimate): April 15, 2014

Study Record Updates

• Last Update Posted (Estimate): June 1, 2016
• Last Update Submitted That Met QC Criteria: May 29, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: ultrasound; diagnostic accuracy; deep vein thrombosis; general practitioner; test; compression ultrasonography
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis
• Other Study ID Numbers: MN-1