General Practitioner-performed Compression Ultrasound for Deep Vein Thrombosis

• ClinicalTrials.gov Identifier: NCT02114983
• Recruitment Status: Completed
• First Posted: April 15, 2014
• Last Update Posted: June 1, 2016
• Sponsor: Azienda Sanitaria Locale ASL 6, Livorno
• Information provided by (Responsible Party): Nicola Mumoli, Azienda Sanitaria Locale ASL 6, Livorno

Tracking Information

• First Submitted Date: April 13, 2014
• First Posted Date: April 15, 2014
• Last Update Posted Date: June 1, 2016
• Study Start Date: January 2015
• Actual Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 13, 2014)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 13, 2014)

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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures (submitted: April 13, 2014): 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 ]
• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: General Practitioner-performed Compression Ultrasound for Deep Vein Thrombosis
• Official Title: Precision and Diagnostic Accuracy of General Practitioner-performed Compression Ultrasound for Proximal Symptomatic Deep Vein Thrombosis

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.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: d-dimer
• 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
• Condition: Deep Vein Thrombosis

Intervention

Other: compression ultrasonography

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

Study Groups/Cohorts

first episode of suspected DVT of the lower limbs

patients with first suspected episode of DVT of the lower limbs

Intervention: Other: compression ultrasonography

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 13, 2014): 1000
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: March 2016
• Actual Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• first episode of DVT of lower limbs

Exclusion Criteria:

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT02114983
• Other Study ID Numbers: MN-1
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Nicola Mumoli, Azienda Sanitaria Locale ASL 6, Livorno
• Original Responsible Party: Same as current
• Current Study Sponsor: Azienda Sanitaria Locale ASL 6, Livorno
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Nicola Mumoli, MD; Section of Vascular Medicine - Livorno Hospital, Italy

• PRS Account: Azienda Sanitaria Locale ASL 6, Livorno
• Verification Date: May 2016