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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

2038 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-11

Study Completion Date

2019-09-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety of a Diagnostic Strategy With D-Dimer Testing for PE

NCT00182221

Venous Thromboembolism

COMPLETED PHASE3

Canadian Pulmonary Embolism Diagnosis Study (CANPEDS)

NCT00182546

Suspected Pulmonary Embolism Deep Venous Thrombosis

TERMINATED PHASE3

Age-adjusted D-dimer Cut-off Levels to Rule Out Pulmonary Embolism

NCT01134068

Pulmonary Embolism

COMPLETED PHASE4

Emergency Medicine Pulmonary Embolism Testing Multicentre Study

NCT06320236

Pulmonary Embolism D-dimer Diagnosis

RECRUITING

Diagnostic Accuracy of Arterial-alveolar Oxygen Gradient in Low Risk Patients With Suspected Pulmonary Embolism

NCT06043726

Pulmonary Embolism

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Embolism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

No CT Pulmonary Angiography

Low Clinical Pretest Probability with D-dimer \< 1000 ug/L and Moderate Clinical Pretest Probability with D-dimer \< 500ug/L

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No