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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

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
Change History
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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
Responsible Party Nicola Mumoli, Azienda Sanitaria Locale ASL 6, Livorno
Study Sponsor Azienda Sanitaria Locale ASL 6, Livorno
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