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

September 13, 2005
September 16, 2005
September 16, 2005
December 1998
Not Provided
symptomatic DVT and PE in follow-up
Same as current
No Changes Posted
  • death
  • deep vein thrombosis diagnosed by venography in those
  • randomized to that intervention
Same as current
Not Provided
Not Provided
D-Dimer and IPG for Recurrent Thrombosis (DIRECT)
D-Dimer and IPG for Recurrent Thrombosis (DIRECT) Study
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.
Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
  • Deep Vein Thrombosis
  • Pulmonary Embolism
Procedure: venogram
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
January 2001
Not Provided

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
Sexes Eligible for Study: All
Child, Adult, Senior
Contact information is only displayed when the study is recruiting subjects
Canada,   Italy
Not Provided
Not Provided
Not Provided
Not Provided
Hamilton Health Sciences Corporation
Heart and Stroke Foundation of Canada
Study Chair: Shannon Bates, M.D. Hamilton Health Sciences Corporation
Principal Investigator: Jeffrey Ginsberg, M.D. Hamilton Health Sciences Corporation
McMaster University
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP