A New Technique to Diagnose Acute and Chronic Deep Vein Thrombosis

Deep Vein Thrombosis Clinical Trial

Official title:

Ultrasound Elastography: a New Technique to Diagnose Acute and Chronic Deep Vein Thrombosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02809638
• Other study ID #: Azienda USL Toscana Nord Ovest
• Status: Completed
• Start date: August 2015
• Est. completion date: June 21, 2017

Study information

• Verified date: January 2019
• Source: Azienda Sanitaria Locale ASL 6, Livorno
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In clinical practice, compression ultrasound (CUS) has become an easy and reliable noninvasive tool for the diagnosis of deep vein thrombosis (DVT).

Currently there are not validated methods to assess the biological age of venous thrombus, and the date of onset of thrombosis. One potential technique to age DVT is ultrasound elastography (UE). UE is a noninvasive technique to measure tissue hardness, and it is well known that thrombi harden as they age. The aim of this study will be to assess the ability of UE to distinguish acute from chronic DVT. The investigators will evaluate prospectively all consecutive outpatients presenting with clinically suspected unprovoked DVT of the lower limbs, and those having a previous diagnosis of DVT for the scheduled 3 months visit of follow-up, for a period of about one year. All the enrolled patients will undergo to the CUS of the lower limbs, and at the same time to the ultrasound elastography by the physician expert in vascular ultrasound. The specialist performing both examinations will be unaware of the time of onset of DVT (acute or chronic). Then the patients will be divided into two groups (group A: patients with acute DVT; group B: patients with chronic DVT at the 3rd month of follow-up). Each examination (CUS and ultrasound elastography) will be repeated three times in the same patient at the same visit, to assess the reproducibility of the technique. The demographic data, medical history, physical examination and the results of CUS and ultrasound elastography will be collected in a case report form (CRF) by another investigator who does not perform the examinations. The blinded CRF will be submitted to a dedicated committee for statistical analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 21, 2017
• Est. primary completion date: June 21, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• acute first episode of unprovoked DVT of lower limbs

• chronic first episode of unprovoked DVT of lower limbs (at third month of follow up)

Exclusion Criteria:

• previous episodes of DVT

• ongoing anticoagulation

• age younger than 18 years

• pregnancy

Related Conditions & MeSH terms

• Compression Ultrasound
• Deep Vein Thrombosis
• Elasticity Imaging Techniques
• Elastography
• Thrombosis
• Venous Thrombosis

Intervention

Other:
• ultrasound elastography

Locations

Country	Name	City	State
Italy	Azienda USL 6 Livorno	Livorno	Tuscany

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Sanitaria Locale ASL 6, Livorno

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Density of clots in patients having acute or 3 month DVT of the lower limb, using the technique of elastosonography.		1 year
Secondary	Change of the density of the clots measured by elastosonography, assessing the elastic deformability of the thrombus, and correlating it with the time of occurrence of the thrombosis (fresh or three month aged clots)		1 year