Canadian Pulmonary Embolism Diagnosis Study (CANPEDS)

April 27, 2006 updated by: Hamilton Health Sciences Corporation

Canadian Pulmonary Embolism Diagnosis Study

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

1126

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Queen Elizabeth II Health Sciences Ctr.
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • McMaster University Medical Centre
      • Hamilton, Ontario, Canada, L8L 2X2
        • Alexander G. Turpie
      • Hamilton, Ontario, Canada, L8N 4A6
        • James Douketis
      • Hamilton, Ontario, Canada, L8V 1C3
        • HHSC Henderson Campus
      • London, Ontario, Canada, N6A 4G5
        • London Health Sciences Centre
      • Ottawa, Ontario, Canada, K1Y 1J8
        • Ottawa Civic Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
DVT or PE during 6 months follow-up

Secondary Outcome Measures

Outcome Measure
bleeding

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamilton Health Sciences Corporation

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: James Douketis, MD, McMaster University
  • Principal Investigator: Mark A Crowther, MD, McMaster University
  • Study Chair: Clive Kearon, MD, PhD, McMaster University
  • Principal Investigator: Jeffrey S Ginsberg, MD, McMaster University
  • Principal Investigator: Alexander G Turpie, MB, McMaster University
  • Principal Investigator: Shannon M Bates, MDCM, 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1998

Study Completion

January 1, 2001

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 15, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

May 3, 2006

Last Update Submitted That Met QC Criteria

April 27, 2006

Last Verified

August 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTMG-1999-CANPEDS
  • CIHR-CANPEDS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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