General Practitioner-performed Compression Ultrasound for Deep Vein Thrombosis
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|ClinicalTrials.gov Identifier: NCT02114983|
Recruitment Status : Completed
First Posted : April 15, 2014
Last Update Posted : June 1, 2016
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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.
|Condition or disease||Intervention/treatment|
|Deep Vein Thrombosis||Other: compression ultrasonography|
|Study Type :||Observational|
|Actual Enrollment :||1000 participants|
|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|
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
- 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.
- 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.
- 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 ]
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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|
- first episode of DVT of lower limbs
- previous episodes of DVT
- ongoing anticoagulation
- age younger than 18 years
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
|Azienda USL 6 Livorno|
|Livorno, Tuscany, Italy, 57100|
|Principal Investigator:||Nicola Mumoli, MD||Section of Vascular Medicine - Livorno Hospital, Italy|
|Responsible Party:||Nicola Mumoli, Dr Nicola Mumoli, M.D., Azienda Sanitaria Locale ASL 6, Livorno|
|Other Study ID Numbers:||
|First Posted:||April 15, 2014 Key Record Dates|
|Last Update Posted:||June 1, 2016|
|Last Verified:||May 2016|
deep vein thrombosis
Embolism and Thrombosis