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Canadian Pulmonary Embolism Diagnosis Study (CANPEDS)

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00182546
First Posted: September 16, 2005
Last Update Posted: May 3, 2006
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.
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
McMaster University
  Purpose

The main objective of the trial is to determine whether D-dimer testing combined with assessment of Pre-Test-Probability (using a standardized clinical model) can be used to markedly simplify the diagnostic process for PE.

It may be safe to omit additional diagnostic testing in selected patients with suspected pulmonary embolism who have a negative D-dimer test


Condition Intervention Phase
Suspected Pulmonary Embolism Deep Venous Thrombosis Procedure: Two diagnostic management strategies Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Canadian Pulmonary Embolism Diagnosis Study

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • DVT or PE during 6 months follow-up

Secondary Outcome Measures:
  • bleeding

Estimated Enrollment: 1126
Study Start Date: August 1998
Estimated Study Completion Date: January 2001
Detailed Description:
To assess the value of the D-dimer in the diagnosis of PE, we had two sub-groups of patients with suspected PE, low and high pre-test probability. Patients could be randomized either to further or no further testing.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Patients with clinically suspected PE

Exclusion Criteria:

  • Treatment with anticoagulants for greater than 24 hours of performance of D-d
  • Comorbid condition limiting survival to less than 3 months
  • Absence of acute symptoms within 7 days prior to presentation
  • Current pregnancy
  • Contraindication to contrast (e.g., allergy, renal failure)
  • Geographic inaccessibility which precludes follow-up
  • Physician believes patient is inappropriate for study
  • failure or inability to provide informed consent
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00182546


Locations
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Ctr.
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Alexander G. Turpie
Hamilton, Ontario, Canada, L8L 2X2
McMaster University Medical Centre
Hamilton, Ontario, Canada, L8N 3Z5
James Douketis
Hamilton, Ontario, Canada, L8N 4A6
HHSC Henderson Campus
Hamilton, Ontario, Canada, L8V 1C3
London Health Sciences Centre
London, Ontario, Canada, N6A 4G5
Ottawa Civic Hospitals
Ottawa, Ontario, Canada, K1Y 1J8
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Canadian Institutes of Health Research (CIHR)
Investigators
Study Chair: Clive Kearon, MD, PhD McMaster University
Principal Investigator: Jeffrey S Ginsberg, MD McMaster University
Principal Investigator: James Douketis, MD McMaster University
Principal Investigator: Alexander G Turpie, MB McMaster University
Principal Investigator: Shannon M Bates, MDCM McMaster University
Principal Investigator: Mark A Crowther, MD McMaster University
Principal Investigator: Jeffrey I Weitz, MD McMaster University
Principal Investigator: Michael Gent, DSc McMaster University
Principal Investigator: Agnes Y Lee, MD McMaster University
  More Information

ClinicalTrials.gov Identifier: NCT00182546     History of Changes
Other Study ID Numbers: CTMG-1999-CANPEDS
CIHR-CANPEDS
First Submitted: September 13, 2005
First Posted: September 16, 2005
Last Update Posted: May 3, 2006
Last Verified: August 2005

Keywords provided by McMaster University:
Pulmonary Embolism
DVT
Venous Thrombosis
D dimer
DD
Thrombosis
Diagnosis

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