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Completed

NCT Number: NCT02114983

General Practitioner-performed Compression Ultrasound for 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.

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Key information

Conditions

Deep Vein Thrombosis Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda USL 6 Livorno

Livorno, Tuscany, 57100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • first episode of DVT of lower limbs

Exclusion criteria

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

Treatment and study plan

compression ultrasonography

Other

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

Primary outcomes

  1. Diagnostic accuracy of General Practitioner in performing CUS for the diagnosis of DVT

    Time frame: 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 outcomes

  1. Precision of CUS performed by General Practitioner for the diagnosis of DVT

    Time frame: 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.

Other outcomes

  1. To assess the prevalence of DVT in patients with a high pre-test probability and/or a positive D-dimer

    Time frame: Up to 2 h hours after ambulatory admission

Sponsors and collaborators

Lead sponsor

Azienda Sanitaria Locale ASL 6, Livorno

Other Gov

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 15, 2014
Registry last updated
Jun 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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