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D-Dimer and IPG for Recurrent Thrombosis (DIRECT)

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. Identifier: NCT00182247
Recruitment Status : Terminated
First Posted : September 16, 2005
Last Update Posted : September 16, 2005
Heart and Stroke Foundation of Canada
Information provided by:
McMaster University

Brief Summary:
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 or disease Intervention/treatment Phase
Deep Vein Thrombosis Pulmonary Embolism Procedure: venogram Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: D-Dimer and IPG for Recurrent Thrombosis (DIRECT) Study
Study Start Date : December 1998
Study Completion Date : January 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots

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

Secondary Outcome Measures :
  1. death
  2. deep vein thrombosis diagnosed by venography in those
  3. randomized to that intervention

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT00182247

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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
CHA - Pavillon Saint-Sacrement
Quebec, Canada, G1S 4L8
IRCCS Policlinico S. Matteo
Pavia, Italy, 27100
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Heart and Stroke Foundation of Canada
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Study Chair: Shannon Bates, M.D. Hamilton Health Sciences Corporation
Principal Investigator: Jeffrey Ginsberg, M.D. Hamilton Health Sciences Corporation

Layout table for additonal information Identifier: NCT00182247    
Other Study ID Numbers: CTMG-1998-DIRECT
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: September 16, 2005
Last Verified: September 2005
Keywords provided by McMaster University:
deep vein thrombosis
pulmonary embolism
venous thromboembolism
Additional relevant MeSH terms:
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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