Pulmonary EmbolismPEGeDNCT02483442
D-dimer Testing Tailored to Clinical Pretest Probability in Suspected Pulmonary Embolism
An observational study of Pulmonary Embolism, run by McMaster University at 9 sites in Canada.
Trial summary
Prospective, multicentre, cohort study assessing a diagnostic management strategy for suspected Pulmonary Embolism with independent central adjudication of outcomes Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- How many people
- 2,038 participants
- Where
- 9 sitesCanada
- Study dates
- 11 Dec 2015to 24 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male or female patients (either outpatients or inpatients) with clinically suspected Pulmonary Embolism.
Who may be able to join
- Patients (either outpatients or inpatients) with clinically suspected Pulmonary Embolism.
Who cannot join
- 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
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- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Canada9 sites
University of Alberta Hospital
Edmonton, Alberta, T6G2V2
HHS- Hamilton General Hospital
Hamilton, Ontario, L8L2X2
St Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
HHS - McMaster University Medical Centre
Hamilton, Ontario, L8S 4K1
Juravinski Hospital
Hamilton, Ontario
London Health Sciences
London, Ontario, N6A5W9
Jewish General Hospital
Montreal
Ottawa Hospital - General Campus
Ottawa, Ontario, K1H8L6
Sherbrooke University Hospital
Sherbrooke, Quebec, J1H5N4
About this study
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)
Prospective, multicentre, cohort study assessing a diagnostic management strategy for suspected Pulmonary Embolism with independent central adjudication of outcomes
Read the 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.
- Conditions
- Pulmonary Embolism
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 Days (+ or - 7days)
Secondary outcomes (3)
Number of patients with bleeding
Major and minor bleeding
Measured: 90 days (+ or - 7days)
Number of patient Deaths
All deaths and cause specific deaths
Measured: 90 days (+ or - 7days)
Number of patients with Venous Thromboembolism
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.
Measured: 90 days (+ or - 7days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study start11 Dec 2015
- Primary completion7 Feb 2019
- Study completion24 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,038 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Clive Kearon, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02483442
- Sponsor's protocol ID
- OCOG-2014-PEGeD
- Acronym
- PEGeD
- Status last verified
- Feb 2023
- First submitted
- 18 Jun 2015
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 31774957
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02483442
- Acronym / sponsor ID
- PEGeD / OCOG-2014-PEGeD
- Conditions
- Pulmonary Embolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,038 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 11 Dec 2015 (actual)
- Primary completion
- 7 Feb 2019 (actual)
- Study completion
- 24 Sep 2019 (actual)
- First posted
- 29 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, multicentre, cohort study assessing a diagnostic management strategy for suspected Pulmonary Embolism with independent central adjudication of outcomes
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male or female patients (either outpatients or inpatients) with clinically suspected Pulmonary Embolism.
Key inclusion criteria (1 listed)
- Patients (either outpatients or inpatients) with clinically suspected Pulmonary Embolism.
Key exclusion criteria (14 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Number of patients with bleeding
Time frame: 90 days (+ or - 7days)
Number of patient Deaths
Time frame: 90 days (+ or - 7days)
Number of patients with Venous Thromboembolism
Time frame: 90 days (+ or - 7days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Derived from this study: PubMed 31774957Kearon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clive Kearon, MD principal investigator
McMaster University
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism, run by McMaster University at 9 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with confirmed symptomatic proximal Deep Vein Thrombosis or Pulmonary Embolism (time frame: 90 Days (+ or - 7days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02483442, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2023.