D-Dimer and IPG for Recurrent Thrombosis (DIRECT)

This study has been terminated.
Sponsor:
Collaborator:
Heart and Stroke Foundation of Canada
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00182247
First received: September 13, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted

September 13, 2005
September 13, 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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
600
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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Italy
 
NCT00182247
CTMG-1998-DIRECT
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