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Ultrasound Elasticity Imaging of Venous Thrombi

Primary Purpose

Thrombosis

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ultrasound
Ultrasound
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Thrombosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Ultrasound imaging of Acute DVT (deep vein thrombosis)

Ultrasound imaging of Chronic DVT (deep vein thrombosis)

Outcomes

Primary Outcome Measures

To determine if ultrasound imaging will aid in the diagnosis and classification of venous blood clots

Secondary Outcome Measures

Follow-up with subjects who have been diagnosed with Acute DVT to see if they develop post-thrombotic syndrome (PTS)

Full Information

First Posted
July 29, 2008
Last Updated
May 23, 2016
Sponsor
University of Michigan
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00726947
Brief Title
Ultrasound Elasticity Imaging of Venous Thrombi
Official Title
Aging Venous Thrombi With Ultrasound Elasticity Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
254 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Ultrasound imaging of Acute DVT (deep vein thrombosis)
Arm Title
2
Arm Type
Experimental
Arm Description
Ultrasound imaging of Chronic DVT (deep vein thrombosis)
Intervention Type
Procedure
Intervention Name(s)
Ultrasound
Intervention Description
Ultrasound imaging of Acute DVT
Intervention Type
Procedure
Intervention Name(s)
Ultrasound
Intervention Description
Ultrasound imaging of Chronic DVT
Primary Outcome Measure Information:
Title
To determine if ultrasound imaging will aid in the diagnosis and classification of venous blood clots
Time Frame
approximately one year
Secondary Outcome Measure Information:
Title
Follow-up with subjects who have been diagnosed with Acute DVT to see if they develop post-thrombotic syndrome (PTS)
Time Frame
first year following diagnosis of acute DVT

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Rubin, M.D.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Ultrasound Elasticity Imaging of Venous Thrombi

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