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Point of Care Ultrasound (US) Versus Detailed Radiology US for Deep Vein Thrombosis (DVT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by University of Missouri-Columbia.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT01045759
First received: January 7, 2010
Last updated: February 8, 2010
Last verified: February 2010
History of Changes
  Purpose

Deep vein thrombosis is a common problem in the intensive care unit and diagnosis is often delayed due to limited availability of a formal duplex ultrasound. Physician performed 2 point compression ultrasonography has been shown to have reasonable accuracy when performed in the emergency department and outpatient setting, but has not been studied on patients in the intensive care unit. We propose an observational study to assess the ability of intensivists to evaluate for deep vein thrombosis using 2 point compression ultrasonography.


Condition
Deep Vein Thrombosis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Intensivist Performed Limited B Mode Compression Ultrasound for Diagnosis of Deep Vein Thrombosis in the Intensive Care Unit

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:
  • The agreement between physician performed ultrasound and formal duplex ultrasonography for detection of proximal deep vein thrombosis. [ Time Frame: 48 hours window from detailed US ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subgroup analysis: location of thrombus (proximal or distal) [ Time Frame: 48 hours window from detailed US ] [ Designated as safety issue: No ]
  • Subgroup analysis: number of days in the hospital prior to exam [ Time Frame: 48 hours window from detailed US ] [ Designated as safety issue: No ]
  • Subgroup analysis: body mass index (BMI) [ Time Frame: 48 hours window from detailed US ] [ Designated as safety issue: No ]
  • Subgroup analysis: weight gain from admission to the time of the exam [ Time Frame: 48 hours window from detailed US ] [ Designated as safety issue: No ]
  • Subgroup analysis: training level of examiner [ Time Frame: 48 hours window from detailed US ] [ Designated as safety issue: No ]
  • Subgroup analysis: difficulty of exam [ Time Frame: 48 hours window from detailed US ] [ Designated as safety issue: No ]
  • Subgroup analysis: specific examiner [ Time Frame: 48 hours window from detailed US ] [ Designated as safety issue: No ]
  • Subgroup analysis: presence or absence of calf vein thrombosis [ Time Frame: at study conclusion ] [ Designated as safety issue: No ]
  • Subgroup analysis: presence or absence of pulmonary embolism [ Time Frame: at study conclusion ] [ Designated as safety issue: No ]
  • Subgroup analysis: DVT location [ Time Frame: at study conclusion ] [ Designated as safety issue: No ]
  • Subgroup analysis: calf vein thrombosis [ Time Frame: at study conclusion ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: November 2009
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The study population will consist of adult patients admitted to the intensive care units at University hospital who have a duplex ultrasound of the lower extremities for detection of deep vein thrombosis ordered by the primary team.

Criteria

Inclusion Criteria:

  • Male and female adults at least 18 years of age
  • Duplex ultrasonography ordered by treating team
  • Admission to the Medical, Cardiac, Burn, or Surgical intensive care units

Exclusion Criteria:

  • Patients less than 18 years of age
  • Patients with a known current DVT
  • patients on whom the exam cannot be performed (above the knee amputation, severe cellulitis of groin or popliteal fossa, hip or knee fracture)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01045759

Contacts
Contact: OUSAMA DABBAGH, MD FCCP 573 882 0808 dabbagho@health.missouri.edu
Contact: Casey Stahlheber, MD 573 882 0808 stahlheberc@health.missouri.edu

Locations
United States, Missouri
University of missouri healthcare Recruiting
Columbia, Missouri, United States, 65212
Contact: DABBAGH, MD         dabbagho@health.missouri.edu    
Sponsors and Collaborators
University of Missouri-Columbia
  More Information

No publications provided

Responsible Party: Casey Stahlheber MD and Ousama Dabbagh MD, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT01045759     History of Changes
Other Study ID Numbers: 1143800
Study First Received: January 7, 2010
Last Updated: February 8, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Missouri-Columbia:
VENOUS THROMBOSIS
ultrasonography
intensive care unit

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

ClinicalTrials.gov processed this record on May 23, 2013