Limited Compression Ultrasound by Emergency Physicians to Exclude Deep Vein Thrombosis

This study has been completed.
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by:
Queen's University
ClinicalTrials.gov Identifier:
NCT01007045
First received: November 2, 2009
Last updated: June 8, 2011
Last verified: June 2011
  Purpose

Deep vein thrombosis is a common condition seen in the Emergency Department. Standard of care for diagnosis of DVT includes a combination of a clinical pre-test probability rule known as Well's criteria, D-dimer blood testing, and Radiology department ultrasound.

The purpose of this study is to determine whether Emergency Physicians can safely rule out deep vein thrombosis using Well's criteria and D-dimer blood testing combined with Emergency department bedside ultrasound.


Condition
Deep Vein Thrombosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Can Emergency Physicians Safely Exclude Proximal Deep Vein Thrombosis Using Limited Compression Emergency Department Ultrasound?

Resource links provided by NLM:


Further study details as provided by Queen's University:

Primary Outcome Measures:
  • First co-primary outcome: sensitivity/specificity of LC U/S vs D-dimer in clinically "unlikely" DVT patients. [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Second co-primary outcome: sensitivity/specificity of LC U/S plus D-dimer vs formal ultrasound in clinically "likely" DVT patients. [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • interobserver reliability of modified Well's criteria [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • learning curve for LC U/S by emergency physicians and residents [ Time Frame: 365 days ] [ Designated as safety issue: No ]
  • difference in diagnostic time interval for patients grouped by pre-test probability [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • number of return visits for formal ultrasound imaging [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • number of patients receiving empirical anticoagulation while formal ultrasound imaging is pending [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Enrollment: 227
Study Start Date: November 2009
Study Completion Date: June 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Clinically "likely"
Subjects deemed clinically likely to have DVT based on modified Well's criteria
Clinically "unlikely"
Subjects deemed clinically unlikely to have DVT based on modified Well's criteria

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

emergency patients suspected of deep vein thrombosis

Criteria

Inclusion Criteria:

  • Age > 16 years
  • Clinically suspected lower extremity DVT

Exclusion Criteria:

  • Known chronic DVT
  • Acute DVT confirmed by prior formal imaging
  • Inability to assess common femoral or popliteal area (due to cast, above knee amputation, etc.)
  • Anticoagulation >48 hours prior to imaging (formal or LCU)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01007045

Locations
Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
Hotel Dieu Hospital
Kingston, Ontario, Canada, K7L 5G2
Sponsors and Collaborators
Queen's University
The Physicians' Services Incorporated Foundation
Investigators
Principal Investigator: Rachel Poley, MD Queen's University
  More Information

No publications provided

Responsible Party: Dr. Rachel Poley, Queen's University
ClinicalTrials.gov Identifier: NCT01007045     History of Changes
Other Study ID Numbers: EMED-123-09
Study First Received: November 2, 2009
Last Updated: June 8, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Queen's University:
deep vein thrombosis
venous thromboembolic disorders
diagnostic ultrasound

Additional relevant MeSH terms:
Emergencies
Thrombosis
Venous Thrombosis
Disease Attributes
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 22, 2014