Ultrasound Elasticity Imaging of Venous Thrombi

May 23, 2016 updated by: Jonathan Rubin, M.D., University of Michigan

Aging Venous Thrombi With Ultrasound Elasticity Imaging

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

254

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Ultrasound imaging of Acute DVT (deep vein thrombosis)
Procedure: Ultrasound
Ultrasound imaging of Acute DVT
Procedure: Ultrasound
Ultrasound imaging of Chronic DVT
EXPERIMENTAL: 2
Ultrasound imaging of Chronic DVT (deep vein thrombosis)
Procedure: Ultrasound
Ultrasound imaging of Acute DVT
Procedure: Ultrasound
Ultrasound imaging of Chronic DVT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine if ultrasound imaging will aid in the diagnosis and classification of venous blood clots
Time Frame: approximately one year
approximately one year

Secondary Outcome Measures

Outcome Measure
Time Frame
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
first year following diagnosis of acute DVT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Jonathan Rubin, M.D., University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2002

Primary Completion (ACTUAL)

May 1, 2010

Study Completion (ACTUAL)

June 1, 2011

Study Registration Dates

First Submitted

July 29, 2008

First Submitted That Met QC Criteria

July 29, 2008

First Posted (ESTIMATE)

August 1, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

May 24, 2016

Last Update Submitted That Met QC Criteria

May 23, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM 0040239
  • NIH ROI HL 78656-01A1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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