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

Completed

• Conditions: Pulmonary Embolism

• Registration Number: NCT02483442
• Lead Sponsor: McMaster University

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.

Study Timeline

• Study First Submitted: 2015-06-18
• Study First Submitted QC: 2015-06-24
• Study First Posted: 2015-06-29
• Study Start: 2015-12-11
• Primary Completion: 2019-02-07
• Study Completion: 2019-09-24
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-03
• Last Update Posted: 2023-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2038

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients with confirmed symptomatic proximal Deep Vein Thrombosis or Pulmonary Embolism	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

Name	Time	Method
Number of patients with Venous Thromboembolism	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.
Number of patients with bleeding	90 days (+ or - 7days)	Major and minor bleeding
Number of patient Deaths	90 days (+ or - 7days)	All deaths and cause specific deaths

Trial Locations

Locations (9)

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada

HHS- Hamilton General Hospital; 🇨🇦 Hamilton, Ontario, Canada

HHS - McMaster University Medical Centre; 🇨🇦 Hamilton, Ontario, Canada

Juravinski Hospital; 🇨🇦 Hamilton, Ontario, Canada

Ottawa Hospital - General Campus; 🇨🇦 Ottawa, Ontario, Canada

Sherbrooke University Hospital; 🇨🇦 Sherbrooke, Quebec, Canada

London Health Sciences; 🇨🇦 London, Ontario, Canada

Jewish General Hospital; 🇨🇦 Montreal, Canada

St Joseph's Healthcare Hamilton; 🇨🇦 Hamilton, Ontario, Canada