D-Dimer Vs Serial Compression Ultrasound Study

NCT ID: NCT00182351

Last Updated: 2006-09-08

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

Clinical Phase

PHASE3

Total Enrollment

810 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-04-30

Study Completion Date

1999-07-31

Brief Summary

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To determine whether d-dimer testing can be used to simplify and reduce the costs of the diagnostic approach to patients with clinically suspected deep vein thrombosis

Detailed Description

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Conditions

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Deep Vein Thrombosis

Keywords

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deep vein thrombosis d-dimer serial compression ultrasound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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D-dimer

Intervention Type PROCEDURE

Serial Compression Ultrasound

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* first suspected deep vein thrombosis
* no previous venous thromboembolism
* referred to thromboembolism outpatient clinic

Exclusion Criteria

* comorbid condition limiting survival to less than six months
* contraindication to venography (contrast allergy, etc.)
* receiving long term warfarin therapy
* receiving full dose heparin therapy for more than 48 hours
* absence of symptoms during the five days immediately prior to presentation
* symptoms of pulmonary embolism
* pregnancy
* geographic inaccessibility which precludes follow-up
Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Health Canada

OTHER_GOV

Sponsor Role collaborator

Hamilton Health Sciences Corporation

OTHER

Sponsor Role lead

Principal Investigators

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Clive Kearon, MB

Role: STUDY_CHAIR

Hamilton Health Sciences and McMaster University

Locations

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Hamilton Health Sciences - Hamilton General Hospital

Hamilton, Ontario, Canada

Site Status

St. Joseph's Hospital

Hamilton, Ontario, Canada

Site Status

Hamilton Health Sciences - Henderson Hospital

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

References

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Kearon C, Ginsberg JS, Douketis J, Crowther MA, Turpie AG, Bates SM, Lee A, Brill-Edwards P, Finch T, Gent M. A randomized trial of diagnostic strategies after normal proximal vein ultrasonography for suspected deep venous thrombosis: D-dimer testing compared with repeated ultrasonography. Ann Intern Med. 2005 Apr 5;142(7):490-6. doi: 10.7326/0003-4819-142-7-200504050-00007.

Reference Type RESULT
PMID: 15809460 (View on PubMed)

Other Identifiers

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CTMG-1995-DDCUS

Identifier Type: -

Identifier Source: org_study_id