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Ultrasound Elasticity Imaging of Venous Thrombi

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by University of Michigan.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00726947
First received: July 29, 2008
Last updated: September 23, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Thrombosis
Procedure: Ultrasound
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Aging Venous Thrombi With Ultrasound Elasticity Imaging

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • To determine if ultrasound imaging will aid in the diagnosis and classification of venous blood clots [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 86
Study Start Date: December 2002
Arms Assigned Interventions
Experimental: 1
Ultrasound imaging of Acute DVT
Procedure: Ultrasound
Ultrasound imaging of Acute DVT
Experimental: 2
Ultrasound imaging of Chronic DVT
Procedure: Ultrasound
Ultrasound imaging of Chronic DVT

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00726947

Locations
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Jonathan Rubin, M.D. University of Michigan
  More Information

No publications provided

Responsible Party: Jonathan Rubin, M.D., University of Michigan Health System
ClinicalTrials.gov Identifier: NCT00726947     History of Changes
Other Study ID Numbers: HUM 0040239, NIH ROI HL 78656-01A1
Study First Received: July 29, 2008
Last Updated: September 23, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Thrombosis
Cardiovascular Diseases
Embolism and Thrombosis
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014