Ultrasound Elasticity Imaging of Venous Thrombi

Early Phase 1

Completed

• Conditions: Thrombosis
• Interventions: Procedure: Ultrasound

• Registration Number: NCT00726947
• Lead Sponsor: University of Michigan

Brief Summary

The purpose of this study is to see if the investigators can use ultrasound imaging to determine the type of clots in patients to help better manage their care.

Detailed Description

Deep vein thrombosis (DVT) is a blood clot and is a common illness that can result in pain and death if not recognized and treated well. Death can occur when the venous clots break off and form pulmonary emboli (PE), which can block the arteries of the lungs. DVT and PE most often complicate the course of sick patients but may also affect healthy persons. DVT can also be a chronic disease. In those instances in which DVT and PE develop, in addition to the death risk, hospitalization is drawn out and healthcare costs are increased. Therefore, the purpose of this study is to see if we can use ultrasound imaging to determine the type of clots in patients to help better manage their care.

Study Timeline

• Study Start: 2002-12
• Study First Submitted: 2008-07-29
• Study First Submitted QC: 2008-07-29
• Study First Posted: 2008-08-01
• Primary Completion: 2010-05
• Study Completion: 2011-06
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-23
• Last Update Posted: 2016-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 254

Inclusion Criteria

• Male or female subjects who have a diagnosis of chronic DVT that is at least 2 weeks old and are free from an acute DVT on top of your chronic DVT.
• Male and female patients who have been diagnosed with an acute blood clot by the Diagnostic Vascular Lab and w/symptoms occurring within the previous 2 weeks.
• Patients under the age of 18 who give assent (permission) and whose parents give consent.
• Adult patients who give consent.

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2	Ultrasound	Ultrasound imaging of Chronic DVT (deep vein thrombosis)
1	Ultrasound	Ultrasound imaging of Acute DVT (deep vein thrombosis)

Primary Outcome Measures

Name	Time	Method
To determine if ultrasound imaging will aid in the diagnosis and classification of venous blood clots	approximately one year

Secondary Outcome Measures

Name	Time	Method
Follow-up with subjects who have been diagnosed with Acute DVT to see if they develop post-thrombotic syndrome (PTS)	first year following diagnosis of acute DVT

Trial Locations

Locations (1)

University of Michigan Health System; 🇺🇸 Ann Arbor, Michigan, United States