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

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ClinicalTrials.gov Identifier: NCT01045759
Recruitment Status : Terminated (Investigator left the institution)
First Posted : January 11, 2010
Last Update Posted : September 30, 2016
Sponsor:
Information provided by (Responsible Party):
University of Missouri-Columbia

Brief Summary:
We propose an observational study to assess the ability of intensivists to evaluate for deep vein thrombosis using 2 point compression ultrasonography.

Condition or disease
DEEP VEIN THROMBOSIS

Detailed Description:
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.

Study Type : Observational
Actual Enrollment : 150 participants
Time Perspective: Prospective
Official Title: Intensivist Performed Limited B Mode Compression Ultrasound for Diagnosis of Deep Vein Thrombosis in the Intensive Care Unit
Study Start Date : November 2009
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Subgroup analysis: location of thrombus (proximal or distal) [ Time Frame: 48 hours window from detailed US ]
  2. Subgroup analysis: number of days in the hospital prior to exam [ Time Frame: 48 hours window from detailed US ]
  3. Subgroup analysis: body mass index (BMI) [ Time Frame: 48 hours window from detailed US ]
  4. Subgroup analysis: weight gain from admission to the time of the exam [ Time Frame: 48 hours window from detailed US ]
  5. Subgroup analysis: training level of examiner [ Time Frame: 48 hours window from detailed US ]
  6. Subgroup analysis: difficulty of exam [ Time Frame: 48 hours window from detailed US ]
  7. Subgroup analysis: specific examiner [ Time Frame: 48 hours window from detailed US ]
  8. Subgroup analysis: presence or absence of calf vein thrombosis [ Time Frame: at study conclusion ]
  9. Subgroup analysis: presence or absence of pulmonary embolism [ Time Frame: at study conclusion ]
  10. Subgroup analysis: DVT location [ Time Frame: at study conclusion ]
  11. Subgroup analysis: calf vein thrombosis [ Time Frame: at study conclusion ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)

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): NCT01045759


Locations
United States, Missouri
University of missouri healthcare
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Casey Stahlheber, MD University of Missouri-Columbia

Responsible Party: University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT01045759     History of Changes
Other Study ID Numbers: 1143800
First Posted: January 11, 2010    Key Record Dates
Last Update Posted: September 30, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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