Limited Compression Ultrasound by Emergency Physicians to Exclude Deep Vein Thrombosis

NCT ID: NCT01007045

Last Updated: 2011-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

227 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Deep Vein Thrombosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Clinically "likely"

Subjects deemed clinically likely to have DVT based on modified Well's criteria

No interventions assigned to this group

Clinically "unlikely"

Subjects deemed clinically unlikely to have DVT based on modified Well's criteria

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Physicians' Services Incorporated Foundation

OTHER

Sponsor Role collaborator

Queen's University

OTHER

Sponsor Role lead

Responsible Party

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Queen's University

Principal Investigators

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Rachel Poley, MD

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Locations

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Kingston General Hospital

Kingston, Ontario, Canada

Site Status

Hotel Dieu Hospital

Kingston, Ontario, Canada

Site Status

Countries

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Canada

References

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Poley RA, Newbigging JL, Sivilotti ML. Estimated effect of an integrated approach to suspected deep venous thrombosis using limited-compression ultrasound. Acad Emerg Med. 2014 Sep;21(9):971-80. doi: 10.1111/acem.12459.

Reference Type DERIVED
PMID: 25269577 (View on PubMed)

Other Identifiers

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EMED-123-09

Identifier Type: -

Identifier Source: org_study_id

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