An observational study in Deep Vein Thrombosis, Compression Ultrasound and Elastography, sponsored by Azienda Sanitaria Locale ASL 6, Livorno. Completed at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-09.
Sponsored by Azienda Sanitaria Locale ASL 6, Livorno · Observational
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.
1,508 studies on the registry are indexed under Thrombosis; 239 are open to participants now.
This study's enrollment of 150 is below the median of 213 across 588 observational studies indexed under Thrombosis.
Browse Thrombosis studies →Azienda Sanitaria Locale ASL 6, Livorno is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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In this study, we 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.
Exclusion Criteria:
patients with first suspected episode of unprovoked DVT of the lower limbs and patients with episode of unprovoked DVT of the lower limbs at third month of follow-up
Other: ultrasound elastography
Density of clots in patients having acute or 3 month DVT of the lower limb, using the technique of elastosonography.
Time frame: 1 year
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)
Time frame: 1 year
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Azienda Sanitaria Locale ASL 6, Livorno