General Practitioner-performed Compression Ultrasound for Deep Vein Thrombosis

NCT ID: NCT02114983

Last Updated: 2016-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-03-31

Brief Summary

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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

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Conditions

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Deep Vein Thrombosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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first episode of suspected DVT of the lower limbs

patients with first suspected episode of DVT of the lower limbs

compression ultrasonography

Intervention Type OTHER

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

Interventions

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compression ultrasonography

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* first episode of DVT of lower limbs

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Sanitaria Locale ASL 6, Livorno

OTHER_GOV

Sponsor Role lead

Responsible Party

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Nicola Mumoli

Dr Nicola Mumoli, M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nicola Mumoli, MD

Role: PRINCIPAL_INVESTIGATOR

Section of Vascular Medicine - Livorno Hospital, Italy

Locations

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Azienda USL 6 Livorno

Livorno, Tuscany, Italy

Site Status

Countries

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Italy

Other Identifiers

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MN-1

Identifier Type: -

Identifier Source: org_study_id

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