Study Stopped
Investigator left the institution
Point of Care Ultrasound (US) Versus Detailed Radiology US for Deep Vein Thrombosis (DVT)
Intensivist Performed Limited B Mode Compression Ultrasound for Diagnosis of Deep Vein Thrombosis in the Intensive Care Unit
1 other identifier
observational
150
1 country
1
Brief Summary
We propose an observational study to assess the ability of intensivists to evaluate for deep vein thrombosis using 2 point compression ultrasonography.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2009
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 7, 2010
CompletedFirst Posted
Study publicly available on registry
January 11, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedSeptember 30, 2016
September 1, 2016
5.5 years
January 7, 2010
September 29, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The agreement between physician performed ultrasound and formal duplex ultrasonography for detection of proximal deep vein thrombosis.
48 hours window from detailed US
Secondary Outcomes (11)
Subgroup analysis: location of thrombus (proximal or distal)
48 hours window from detailed US
Subgroup analysis: number of days in the hospital prior to exam
48 hours window from detailed US
Subgroup analysis: body mass index (BMI)
48 hours window from detailed US
Subgroup analysis: weight gain from admission to the time of the exam
48 hours window from detailed US
Subgroup analysis: training level of examiner
48 hours window from detailed US
- +6 more secondary outcomes
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of missouri healthcare
Columbia, Missouri, 65212, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Casey Stahlheber, MD
University of Missouri-Columbia
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2010
First Posted
January 11, 2010
Study Start
November 1, 2009
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
September 30, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will not share