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Canadian Pulmonary Embolism Diagnosis Study (CANPEDS)

This study has been terminated.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00182546
First received: September 13, 2005
Last updated: April 27, 2006
Last verified: August 2005
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Canadian Pulmonary Embolism Diagnosis Study

Resource links provided by NLM:

U.S. FDA Resources

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00182546

Locations
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Ctr.
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
McMaster University Medical Centre
Hamilton, Ontario, Canada, L8N 3Z5
HHSC Henderson Campus
Hamilton, Ontario, Canada, L8V 1C3
Alexander G. Turpie
Hamilton, Ontario, Canada, L8L 2X2
James Douketis
Hamilton, Ontario, Canada, L8N 4A6
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

No publications provided

ClinicalTrials.gov Identifier: NCT00182546     History of Changes
Other Study ID Numbers: CTMG-1999-CANPEDS, CIHR-CANPEDS
Study First Received: September 13, 2005
Last Updated: April 27, 2006
Health Authority: Canada: Ethics Review Committee

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

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

ClinicalTrials.gov processed this record on May 16, 2013