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

This study has been completed.
Sponsor:
Collaborator:
Deseret Foundation
Information provided by:
Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier:
NCT00333697
First received: June 2, 2006
Last updated: March 17, 2011
Last verified: March 2011
  Purpose

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 Intervention
Deep Vein Thrombosis
Other: Comprehensive Duplex Ultrasound (diagnostic study)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Ultrasound-sparing Strategy for Suspected DVT: A Prospective Clinical Cohort Study

Resource links provided by NLM:


Further study details as provided by Intermountain Health Care, Inc.:

Primary Outcome Measures:
  • Symptomatic VTE [ Time Frame: Three months ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 199
Study Start Date: November 2005
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
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.
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00333697

Locations
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
Principal Investigator: Scott M Stevens, MD Intermountain Medical Center
Principal Investigator: Charles G Elliott, MD Intermountain Medical Center
  More Information

Publications:
Responsible Party: Scott M. Stevens, MD, Intermountain Healthcare
ClinicalTrials.gov Identifier: NCT00333697     History of Changes
Other Study ID Numbers: 05.2033
Study First Received: June 2, 2006
Last Updated: March 17, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Intermountain Health Care, Inc.:
Deep vein thrombosis
Duplex ultrasound
Pulmonary embolism

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

ClinicalTrials.gov processed this record on April 15, 2014