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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01007045
Other study ID # EMED-123-09
Secondary ID
Status Completed
Phase N/A
First received November 2, 2009
Last updated June 8, 2011
Start date November 2009
Est. completion date June 2011

Study information

Verified date June 2011
Source Queen's University
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 227
Est. completion date June 2011
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility 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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Canada Hotel Dieu Hospital Kingston Ontario
Canada Kingston General Hospital Kingston Ontario

Sponsors (2)

Lead Sponsor Collaborator
Queen's University The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary First co-primary outcome: sensitivity/specificity of LC U/S vs D-dimer in clinically "unlikely" DVT patients. 3 days No
Primary Second co-primary outcome: sensitivity/specificity of LC U/S plus D-dimer vs formal ultrasound in clinically "likely" DVT patients. 3 days No
Secondary interobserver reliability of modified Well's criteria 3 days No
Secondary learning curve for LC U/S by emergency physicians and residents 365 days No
Secondary difference in diagnostic time interval for patients grouped by pre-test probability 3 days No
Secondary number of return visits for formal ultrasound imaging 3 days No
Secondary number of patients receiving empirical anticoagulation while formal ultrasound imaging is pending 3 days No
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