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Ultrasound Elasticity Imaging of Venous Thrombi

This study has been completed.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Jonathan Rubin, M.D., University of Michigan
ClinicalTrials.gov Identifier:
NCT00726947
First received: July 29, 2008
Last updated: May 23, 2016
Last verified: May 2016
  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 [ Time Frame: approximately one year ] [ 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 ]

Enrollment: 254
Study Start Date: December 2002
Study Completion Date: June 2011
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Ultrasound imaging of Acute DVT (deep vein thrombosis)
Procedure: Ultrasound
Ultrasound imaging of Acute DVT
Experimental: 2
Ultrasound imaging of Chronic DVT (deep vein thrombosis)
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

Ages Eligible for Study:   Child, Adult, Senior
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:

  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
National Institutes of Health (NIH)
Investigators
Principal Investigator: Jonathan Rubin, M.D. University of Michigan
  More Information

Responsible Party: Jonathan Rubin, M.D., Principal Investigator, University of Michigan
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: May 23, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

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

ClinicalTrials.gov processed this record on September 30, 2016