Ultrasound Elasticity Imaging of Venous Thrombi

Thrombosis Clinical Trial

Official title:

Aging Venous Thrombi With Ultrasound Elasticity Imaging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00726947
• Other study ID #: HUM 0040239
• Secondary ID: NIH ROI HL 78656
• Status: Completed
• Phase: Phase 0
• First received: July 29, 2008
• Last updated: May 23, 2016
• Start date: December 2002
• Est. completion date: June 2011

Study information

• Verified date: May 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 254
• Est. completion date: June 2011
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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:

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Thrombosis

Intervention

Procedure:
• Ultrasound
Ultrasound imaging of Acute DVT
• Ultrasound
Ultrasound imaging of Chronic DVT

Locations

Country	Name	City	State
United States	University of Michigan Health System	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine if ultrasound imaging will aid in the diagnosis and classification of venous blood clots		approximately one year	No
Secondary	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	No