Clinical trial NCT02483442: D-dimer Testing Tailored to Clinical Pretest Probability in Suspected Pulmonary Embolism
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Embolism
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2015-06-29
Enrollment: 2038
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male or female patients (either outpatients or inpatients) with clinically suspected Pulmonary Embolism.

Brief summary: 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.

Eligibility 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.

Primary outcomes:
measure: Number of patients with confirmed symptomatic proximal Deep Vein Thrombosis or Pulmonary Embolism
timeFrame: 90 Days (+ or - 7days)
Secondary outcomes:
measure: Number of patients with bleeding
timeFrame: 90 days (+ or - 7days)
measure: Number of patient Deaths
timeFrame: 90 days (+ or - 7days)
measure: Number of patients with Venous Thromboembolism
timeFrame: 90 days (+ or - 7days)
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Hamilton
country: Canada
facility: HHS- Hamilton General Hospital
state: Ontario
city: Hamilton
country: Canada
facility: St Joseph's Healthcare Hamilton
state: Ontario
city: Hamilton
country: Canada
facility: HHS - McMaster University Medical Centre
state: Ontario
city: Hamilton
country: Canada
facility: Juravinski Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital - General Campus
state: Ontario
city: Sherbrooke
country: Canada
facility: Sherbrooke University Hospital
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital
Study officials:
affiliation: McMaster University
name: Clive Kearon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.