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Single Comprehensive Ultrasound to Rule Out DVT in High-risk Patients

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ClinicalTrials.gov Identifier: NCT00333697
Recruitment Status : Completed
First Posted : June 6, 2006
Last Update Posted : March 21, 2011
Sponsor:
Collaborator:
Deseret Foundation
Information provided by:
Intermountain Health Care, Inc.

Brief Summary:
To determine the rate of thromboembolic complications (including death attributed to thromboembolic disease) in patients with a score rated as "DVT likely" on a formalized scoring system, when anticoagulation therapy is withheld on the basis of a negative comprehensive duplex ultrasound examination. Participants are followed for three months after a normal ultrasound to determine if any symptoms attributable to deep vein thrombosis develop. Any such symptoms are verified by objective tests.

Condition or disease Intervention/treatment Phase
Deep Vein Thrombosis Other: Comprehensive Duplex Ultrasound (diagnostic study) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 199 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Ultrasound-sparing Strategy for Suspected DVT: A Prospective Clinical Cohort Study
Study Start Date : November 2005
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

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Intervention Details:
  • Other: Comprehensive Duplex Ultrasound (diagnostic study)
    A sigle duplex ultrasound examination of the deep venous system of the leg(s) suspected of deep vein thrombosis. Deep veins of the leg are examined for evidence of thrombosis from the inguinal ligament to the level of the malleolus.


Primary Outcome Measures :
  1. Symptomatic VTE [ Time Frame: Three months ]
    The rate of objectively-confirmed thromboembolic complications (including death attributed to thromboembolic disease) in patients with a score rated as "DVT likely" on a formalized scoring system, when anticoagulation therapy is withheld based on a single, negative comprehensive duplex ultrasound.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be referred for suspected first ipsilateral episode of acute DVT of the lower extremities.
  • Be > 18 y.o.
  • Provide written informed consent

Exclusion Criteria:

  • Pregnant.
  • Compression ultrasonography cannot be performed due to physical or technical reasons.
  • Long-term follow-up will not be possible due to geographic inaccessibility, homelessness or lack of a telephone.
  • Therapeutic doses of an anticoagulant have been received for more than 24 hours before enrollment.
  • Informed consent cannot be obtained.
  • Long term anticoagulation will be required for another diagnosis (e.g. atrial fibrillation).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00333697


Locations
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United States, Utah
Intermoutain Medical Center
Murray, Utah, United States, 84157
LDS Hospital
Salt Lake City, Utah, United States, 84093
Sponsors and Collaborators
Intermountain Health Care, Inc.
Deseret Foundation
Investigators
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Principal Investigator: Scott M Stevens, MD Intermountain Medical Center
Principal Investigator: Charles G Elliott, MD Intermountain Medical Center

Publications:
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Responsible Party: Scott M. Stevens, MD, Intermountain Healthcare
ClinicalTrials.gov Identifier: NCT00333697    
Other Study ID Numbers: 05.2033
First Posted: June 6, 2006    Key Record Dates
Last Update Posted: March 21, 2011
Last Verified: March 2011
Keywords provided by Intermountain Health Care, Inc.:
Deep vein thrombosis
Duplex ultrasound
Pulmonary embolism
Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases