D-Dimer Vs Serial Compression Ultrasound Study

This study has been completed.

Sponsors and Collaborators:	Hamilton Health Sciences National Health Research Development Program of Health Canada
Information provided by:	McMaster University
ClinicalTrials.gov Identifier:	NCT00182351

Purpose

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

Condition	Intervention	Phase
Deep Vein Thrombosis	Procedure: D-dimer Procedure: Serial Compression Ultrasound	Phase III

MedlinePlus related topics: Deep Vein Thrombosis Ultrasound

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Evaluation of the Safety, Efficacy and Cost-Effectiveness of Two Strategies for the Diagnosis of Deep Vein Thrombosis

Further study details as provided by McMaster University:

Primary Outcome Measures:

safety of withholding anticoagulants

Secondary Outcome Measures:

deep vein thrombosis
pulmonary embolism
death

Estimated Enrollment:	810
Study Start Date:	April 1996
Estimated Study Completion Date:	July 1999

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00182351

Locations

Canada, Ontario
Hamilton Health Sciences - Henderson Hospital
Hamilton, Ontario, Canada, L8V 1C3
Hamilton Health Sciences - Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
St. Joseph's Hospital
Hamilton, Ontario, Canada, L8N 4A6

Sponsors and Collaborators

Hamilton Health Sciences

National Health Research Development Program of Health Canada

Investigators

Study Chair:

Clive Kearon, MB

Hamilton Health Sciences and McMaster University

More Information

Publications of Results:

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. Summary for patients in: Ann Intern Med. 2005 Apr 5;142(7):I48.

Study ID Numbers:	CTMG-1995-DDCUS
Study First Received:	September 13, 2005
Last Updated:	September 7, 2006
ClinicalTrials.gov Identifier:	NCT00182351
Health Authority:	Canada: Health Canada

Keywords provided by McMaster University:

deep vein thrombosis
d-dimer
serial compression ultrasound

Study placed in the following topic categories:

Embolism and Thrombosis
Embolism
Vascular Diseases

Fibrin fragment D
Venous Thrombosis
Thrombosis

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009