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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
  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
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:

U.S. FDA Resources

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00182247

Locations
Canada, Ontario
McMaster University Medical Centre
Hamilton, Ontario, Canada, L8N 3Z5
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
Henderson General Hospital
Hamilton, Ontario, Canada, L8V 1C3
St. Joseph' Hospital
Hamilton, Ontario, Canada, L8N 4A6
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

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
DVT
pulmonary embolism
PE
 venous thromboembolism
VTE
d-dimer
IPG

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

ClinicalTrials.gov processed this record on May 19, 2013