NCT02483442

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,038

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2015

Typical duration for all trials

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 29, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

December 11, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2019

Completed
Last Updated

February 6, 2023

Status Verified

February 1, 2023

Enrollment Period

3.2 years

First QC Date

June 18, 2015

Last Update Submit

February 3, 2023

Conditions

Pulmonary Embolism

Outcome Measures

Primary Outcomes (1)

  • Number of patients with confirmed symptomatic proximal Deep Vein Thrombosis or Pulmonary Embolism

    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.

    90 Days (+ or - 7days)

Secondary Outcomes (3)

  • Number of patients with bleeding

    90 days (+ or - 7days)

  • Number of patient Deaths

    90 days (+ or - 7days)

  • Number of patients with Venous Thromboembolism

    90 days (+ or - 7days)

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Male or female patients (either outpatients or inpatients) with clinically suspected Pulmonary Embolism.

You may qualify if:

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

You may not qualify if:

  • Age less than 18 years.
  • Treated with full-dose anticoagulation for ≥ 24 hours before D-dimer was measured.
  • Major surgery (general or spinal anesthesia) in the past 21 days.
  • 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.
  • Computed Tomography Pulmonary Angiogram or Ventilation Perfusion Scan was performed:
  • before Clinical Pretest Probability was documented, or
  • in a patient with Low Clinical Pretest Probability and a D-dimer level \<1,000 ug/L (or equivalent), or
  • in a patient with Moderate Clinical Pretest Probability and a D-dimer level \<500 ug/L (or equivalent).
  • 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.
  • Ongoing need for anticoagulant therapy.
  • Life expectancy less than 3 months.
  • Geographic inaccessibility which precludes follow-up.
  • Known pregnancy.
  • Inability to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

University of Alberta Hospital

Edmonton, Alberta, T6G2V2, Canada

Location

HHS- Hamilton General Hospital

Hamilton, Ontario, L8L2X2, Canada

Location

St Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

HHS - McMaster University Medical Centre

Hamilton, Ontario, L8S 4K1, Canada

Location

Juravinski Hospital

Hamilton, Ontario, Canada

Location

London Health Sciences

London, Ontario, N6A5W9, Canada

Location

Ottawa Hospital - General Campus

Ottawa, Ontario, K1H8L6, Canada

Location

Sherbrooke University Hospital

Sherbrooke, Quebec, J1H5N4, Canada

Location

Jewish General Hospital

Montreal, Canada

Location

Related Publications (1)

  • Kearon C, de Wit K, Parpia S, Schulman S, Afilalo M, Hirsch A, Spencer FA, Sharma S, D'Aragon F, Deshaies JF, Le Gal G, Lazo-Langner A, Wu C, Rudd-Scott L, Bates SM, Julian JA; PEGeD Study Investigators. Diagnosis of Pulmonary Embolism with d-Dimer Adjusted to Clinical Probability. N Engl J Med. 2019 Nov 28;381(22):2125-2134. doi: 10.1056/NEJMoa1909159.

    PMID: 31774957DERIVED

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Clive Kearon, MD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2015

First Posted

June 29, 2015

Study Start

December 11, 2015

Primary Completion

February 7, 2019

Study Completion

September 24, 2019

Last Updated

February 6, 2023

Record last verified: 2023-02

Locations

CA(9)