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General Practitioner-performed Compression Ultrasound for Deep Vein Thrombosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02114983
Recruitment Status : Completed
First Posted : April 15, 2014
Last Update Posted : June 1, 2016
Sponsor:
Information provided by (Responsible Party):
Nicola Mumoli, Azienda Sanitaria Locale ASL 6, Livorno

Study Description
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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.


Condition or disease Intervention/treatment
Deep Vein Thrombosis Other: compression ultrasonography

Study Design
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Study Type : Observational
Actual Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Precision and Diagnostic Accuracy of General Practitioner-performed Compression Ultrasound for Proximal Symptomatic Deep Vein Thrombosis
Study Start Date : January 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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 ]

Biospecimen Description:
d-dimer

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

  • first episode of DVT of lower limbs

Exclusion Criteria:

  • previous episodes of DVT
  • ongoing anticoagulation
  • age younger than 18 years
  • pregnancy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02114983


Locations
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Italy
Azienda USL 6 Livorno
Livorno, Tuscany, Italy, 57100
Sponsors and Collaborators
Azienda Sanitaria Locale ASL 6, Livorno
Investigators
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Principal Investigator: Nicola Mumoli, MD Section of Vascular Medicine - Livorno Hospital, Italy
More Information
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Responsible Party: Nicola Mumoli, Dr Nicola Mumoli, M.D., Azienda Sanitaria Locale ASL 6, Livorno
ClinicalTrials.gov Identifier: NCT02114983    
Other Study ID Numbers: MN-1
First Posted: April 15, 2014    Key Record Dates
Last Update Posted: June 1, 2016
Last Verified: May 2016
Keywords provided by Nicola Mumoli, Azienda Sanitaria Locale ASL 6, Livorno:
deep vein thrombosis
diagnostic accuracy
general practitioner
 test
compression ultrasonography
ultrasound
Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases