D-Dimer and IPG for Recurrent Thrombosis (DIRECT)

This study has been terminated.
Heart and Stroke Foundation of Canada
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
First received: September 13, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Genders Eligible for Study:   Both
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
  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: NCT00182247

Canada, Ontario
Chedoke Hospital
Hamilton, Ontario, Canada
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
Henderson General Hospital
Hamilton, Ontario, Canada, L8V 1C3
McMaster University Medical Centre
Hamilton, Ontario, Canada, L8N 3Z5
St. Joseph' Hospital
Hamilton, Ontario, Canada, L8N 4A6
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
Study Chair: Shannon Bates, M.D. Hamilton Health Sciences Corporation
Principal Investigator: Jeffrey Ginsberg, M.D. Hamilton Health Sciences Corporation
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00182247     History of Changes
Other Study ID Numbers: CTMG-1998-DIRECT
Study First Received: September 13, 2005
Last Updated: September 13, 2005
Health Authority: Canada: Health Canada

Keywords provided by McMaster University:
deep vein thrombosis
pulmonary embolism
venous thromboembolism

Additional relevant MeSH terms:
Pulmonary Embolism
Venous Thrombosis
Cardiovascular Diseases
Embolism and Thrombosis
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 30, 2015