General Practitioner-performed Compression Ultrasound for Deep Vein Thrombosis

NCT02114983 | Completed

• 1 other identifier: MN-1
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Deep Vein Thrombosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Precision of CUS performed by General Practitioner for the diagnosis of DVT

  Up to 2 h hours after ambulatory admission

Other Outcomes (1)

• 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

Study Arms (1)

first episode of suspected DVT of the lower limbs

patients with first suspected episode of DVT of the lower limbs

Other: compression ultrasonography

Interventions

compression ultrasonography OTHER

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

first episode of suspected DVT of the lower limbs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• first episode of DVT of lower limbs

You may not qualify if:

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

Sponsors & Collaborators

• Azienda Sanitaria Locale ASL 6, Livorno: lead

Study Sites (1)

Azienda USL 6 Livorno

Livorno, Tuscany, 57100, Italy

Location

Biospecimen

d-dimer

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Nicola Mumoli, MD

  Section of Vascular Medicine - Livorno Hospital, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Nicola Mumoli, M.D.

Study Record Dates

• First Submitted: April 13, 2014
• First Posted: April 15, 2014
• Study Start: January 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: June 1, 2016

Record last verified: 2016-05

Locations

IT (1)