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D-dimer Testing Tailored to Clinical Pretest Probability in Suspected Pulmonary Embolism (PEGeD)

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ClinicalTrials.gov Identifier: NCT02483442
Recruitment Status : Active, not recruiting
First Posted : June 29, 2015
Last Update Posted : May 11, 2018
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
McMaster University

Brief Summary:
Prospective, multicentre, cohort study assessing a diagnostic management strategy for suspected Pulmonary Embolism with independent central adjudication of outcomes

Condition or disease
Pulmonary Embolism

Detailed Description:
This is a prospective, multi-centre, cohort study that will assess a new diagnostic management strategy for suspected Pulmonary Embolism (inpatients and outpatients). The new diagnostic strategy is designed to reduce the use of imaging tests for Pulmonary Embolism, particularly Computed Tomography Pulmonary Angiogram, by excluding Pulmonary Embolism with combinations of Clinical Pretest Probability and D-dimer results in a higher proportion of patients. The safety of this management strategy will be established by demonstrating a very low rate of proximal Deep Vein Thrombosis or Pulmonary Embolism during 90 days of follow-up in patients who had anticoagulant therapy withheld in response to negative diagnostic testing. Diagnostic test utilization will be assessed. All clinical outcomes will be adjudicated by a central independent adjudication committee that will be blind to initial D-dimer measurements and patient management.

Study Type : Observational
Actual Enrollment : 2038 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: D-dimer Testing,Tailored to Clinical Pretest Probability to Reduce the Use of CT Pulmonary Angiography in Suspected Pulmonary Embolism: A Management Study (The Pulmonary Embolism Graduated D-dimer [PEGeD] Study)
Actual Study Start Date : December 11, 2015
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Group/Cohort
No CT Pulmonary Angiography
Low Clinical Pretest Probability with D-dimer < 1000 ug/L and Moderate Clinical Pretest Probability with D-dimer < 500ug/L
CT Pulmonary Angiography Required
Low Clinical Pretest Probability with D-dimer > or = 1000ug/L and Moderate Clinical Pretest Probability with D-dimer > or = 500 ug/L and High Clinical Pretest Probability



Primary Outcome Measures :
  1. Number of patients with confirmed symptomatic proximal Deep Vein Thrombosis or Pulmonary Embolism [ Time Frame: 90 Days (+ or - 7days) ]
    Proximal Deep Vein Thrombosis includes thrombosis confined to the calf vein trifurcation but not isolated more distal Deep Vein Thrombosis. Pulmonary Embolism does not include isolated sub-segmental abnormalities on Computed Tomography Pulmonary Angiography.


Secondary Outcome Measures :
  1. Number of patients with bleeding [ Time Frame: 90 days (+ or - 7days) ]
    Major and minor bleeding

  2. Number of patient Deaths [ Time Frame: 90 days (+ or - 7days) ]
    All deaths and cause specific deaths

  3. Number of patients with Venous Thromboembolism [ Time Frame: 90 days (+ or - 7days) ]
    Venous Thromboembolism, including events that do not satisfy the primary outcome (e.g. isolated distal Deep Vein Thrombosis or subsegmental Pulmonary Embolism) but that are confirmed by the adjudication committee.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male or female patients (either outpatients or inpatients) with clinically suspected Pulmonary Embolism.
Criteria

Inclusion Criteria:

  • Patients (either outpatients or inpatients) with clinically suspected Pulmonary Embolism.

Exclusion Criteria:

  1. Age less than 18 years.
  2. Treated with full-dose anticoagulation for ≥ 24 hours before D-dimer was measured.
  3. Major surgery (general or spinal anesthesia) in the past 21 days.
  4. Result of the D-dimer assay that will be used to manage the patient in the study is known before Clinical Pretest Probability was done.
  5. Computed Tomography Pulmonary Angiogram or Ventilation Perfusion Scan was performed:

    1. before Clinical Pretest Probability was documented, or
    2. in a patient with Low Clinical Pretest Probability and a D-dimer level <1,000 ug/L (or equivalent), or
    3. in a patient with Moderate Clinical Pretest Probability and a D-dimer level <500 ug/L (or equivalent).
  6. Computed Tomography of the chest with contrast will be performed for another reason (e.g. to assess for malignant disease or aortic dissection), and would be performed even if Pulmonary Embolism is excluded by Clinical Pretest Probability and D-dimer testing.
  7. Ongoing need for anticoagulant therapy.
  8. Life expectancy less than 3 months.
  9. Geographic inaccessibility which precludes follow-up.
  10. Known pregnancy.
  11. Inability to provide informed consent.

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): NCT02483442


Locations
Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G2V2
Canada, Ontario
HHS- Hamilton General Hospital
Hamilton, Ontario, Canada, L8L2X2
St Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
HHS - McMaster University Medical Centre
Hamilton, Ontario, Canada, L8S 4K1
Juravinski Hospital
Hamilton, Ontario, Canada
London Health Sciences
London, Ontario, Canada, N6A5W9
Ottawa Hospital - General Campus
Ottawa, Ontario, Canada, K1H8L6
Canada, Quebec
Sherbrooke University Hospital
Sherbrooke, Quebec, Canada, J1H5N4
Canada
Jewish General Hospital
Montreal, Canada
Sponsors and Collaborators
McMaster University
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Clive Kearon, MD McMaster University

Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT02483442     History of Changes
Other Study ID Numbers: OCOG-2014-PEGeD
First Posted: June 29, 2015    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Fibrin fragment D
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants