D-Dimer Vs Serial Compression Ultrasound Study

This study has been completed.
Sponsor:
Collaborator:
Health Canada
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00182351
First received: September 13, 2005
Last updated: September 7, 2006
Last verified: September 2006
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of the Safety, Efficacy and Cost-Effectiveness of Two Strategies for the Diagnosis of Deep Vein Thrombosis

Resource links provided by NLM:


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
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: 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 Corporation
Health Canada
Investigators
Study Chair: Clive Kearon, MB Hamilton Health Sciences and McMaster University
  More Information

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

Keywords provided by McMaster University:
deep vein thrombosis
d-dimer
serial compression ultrasound

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Fibrin fragment D
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 31, 2014