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

Pulmonary Embolism Clinical Trial

— PEGeD  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02483442
• Other study ID #: OCOG-2014-PEGeD
• Status: Completed
• Start date: December 11, 2015
• Est. completion date: September 24, 2019

Study information

• Verified date: February 2023
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2038
• Est. completion date: September 24, 2019
• Est. primary completion date: February 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Locations

Country	Name	City	State
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	HHS - McMaster University Medical Centre	Hamilton	Ontario
Canada	HHS- Hamilton General Hospital	Hamilton	Ontario
Canada	Juravinski Hospital	Hamilton	Ontario
Canada	St Joseph's Healthcare Hamilton	Hamilton	Ontario
Canada	London Health Sciences	London	Ontario
Canada	Jewish General Hospital	Montreal
Canada	Ottawa Hospital - General Campus	Ottawa	Ontario
Canada	Sherbrooke University Hospital	Sherbrooke	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of patients with bleeding	Major and minor bleeding	90 days (+ or - 7days)
Secondary	Number of patient Deaths	All deaths and cause specific deaths	90 days (+ or - 7days)
Secondary	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.	90 days (+ or - 7days)