Ultrasound Elasticity Imaging of Venous Thrombi

NCT ID: NCT00726947

Last Updated: 2016-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

254 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2011-06-30

Brief Summary

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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

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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.

Conditions

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Thrombosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

Ultrasound imaging of Acute DVT (deep vein thrombosis)

Group Type EXPERIMENTAL

Ultrasound

Intervention Type PROCEDURE

Ultrasound imaging of Acute DVT

2

Ultrasound imaging of Chronic DVT (deep vein thrombosis)

Group Type EXPERIMENTAL

Ultrasound

Intervention Type PROCEDURE

Ultrasound imaging of Chronic DVT

Interventions

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Ultrasound

Ultrasound imaging of Acute DVT

Intervention Type PROCEDURE

Ultrasound

Ultrasound imaging of Chronic DVT

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Jonathan Rubin, M.D.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jonathan Rubin, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan Health System

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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NIH ROI HL 78656-01A1

Identifier Type: -

Identifier Source: secondary_id

HUM 0040239

Identifier Type: -

Identifier Source: org_study_id

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