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D-Dimer and IPG for Recurrent Thrombosis (DIRECT)

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00182247
First Posted: September 16, 2005
Last Update Posted: September 16, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Heart and Stroke Foundation of Canada
Information provided by:
McMaster University
  Purpose
To simplify and improve the diagnostic approach to patients with clinically suspected recurrent DVT by determining whether the results of the combination of IPG and d-dimer testing, using a whole blood agglutination assay, can be used in the management of such patients.

Condition Intervention Phase
Deep Vein Thrombosis Pulmonary Embolism Procedure: venogram Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: D-Dimer and IPG for Recurrent Thrombosis (DIRECT) Study

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • symptomatic DVT and PE in follow-up

Secondary Outcome Measures:
  • death
  • deep vein thrombosis diagnosed by venography in those
  • randomized to that intervention

Estimated Enrollment: 600
Study Start Date: December 1998
Estimated Study Completion Date: January 2001
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • suspected deep vein thrombosis
  • history of previous DVT or PE

Exclusion Criteria:

  • comorbid condition limiting survival to less than 6 months
  • contraindication to contrast medium (allergy, renal dysfunction, creatinine > 150mcmol/L)
  • receiving long-term warfarin or heparin therapy
  • received full-dose heparin therapy for more than 48 hours
  • pregnancy
  • symptomatic for pulmonary embolism
  • absence of symptoms within 5 days of presentation
  • geographic inaccessibility which precludes follow-up
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00182247


Locations
Canada, Ontario
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
McMaster University Medical Centre
Hamilton, Ontario, Canada, L8N 3Z5
St. Joseph' Hospital
Hamilton, Ontario, Canada, L8N 4A6
Henderson General Hospital
Hamilton, Ontario, Canada, L8V 1C3
Chedoke Hospital
Hamilton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada, N6A 4G5
Canada
CHA - Pavillon Saint-Sacrement
Quebec, Canada, G1S 4L8
Italy
IRCCS Policlinico S. Matteo
Pavia, Italy, 27100
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Heart and Stroke Foundation of Canada
Investigators
Study Chair: Shannon Bates, M.D. Hamilton Health Sciences Corporation
Principal Investigator: Jeffrey Ginsberg, M.D. Hamilton Health Sciences Corporation
  More Information

ClinicalTrials.gov Identifier: NCT00182247     History of Changes
Other Study ID Numbers: CTMG-1998-DIRECT
First Submitted: September 13, 2005
First Posted: September 16, 2005
Last Update Posted: September 16, 2005
Last Verified: September 2005

Keywords provided by McMaster University:
deep vein thrombosis
DVT
pulmonary embolism
PE
venous thromboembolism
VTE
d-dimer
IPG

Additional relevant MeSH terms:
Thrombosis
Embolism
Pulmonary Embolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Fibrin fragment D
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants