Canadian Pulmonary Embolism Diagnosis Study (CANPEDS)

Phase 3TerminatedNCT00182546

Hamilton Health Sciences Corporation1,126 enrolled

Overview

The main objective of the trial is to determine whether D-dimer testing combined with assessment of Pre-Test-Probability (using a standardized clinical model) can be used to markedly simplify the diagnostic process for PE. It may be safe to omit additional diagnostic testing in selected patients with suspected pulmonary embolism who have a negative D-dimer test

To assess the value of the D-dimer in the diagnosis of PE, we had two sub-groups of patients with suspected PE, low and high pre-test probability. Patients could be randomized either to further or no further testing.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,126

Conditions

Suspected Pulmonary Embolism Deep Venous Thrombosis

Interventions

Two diagnostic management strategiesPROCEDURE

Eligibility

Sex: ALLMin age: 0 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with clinically suspected PE Exclusion Criteria: * Treatment with anticoagulants for greater than 24 hours of performance of D-d * Comorbid condition limiting survival to less than 3 months * Absence of acute symptoms within 7 days prior to presentation * Current pregnancy * Contraindication to contrast (e.g., allergy, renal failure) * Geographic inaccessibility which precludes follow-up * Physician believes patient is inappropriate for study * failure or inability to provide informed consent

Locations (7)

Queen Elizabeth II Health Sciences Ctr.

Halifax, Nova Scotia, Canada

Alexander G. Turpie

Hamilton, Ontario, Canada

McMaster University Medical Centre

Hamilton, Ontario, Canada

James Douketis

Hamilton, Ontario, Canada

Outcomes

Primary Outcomes

DVT or PE during 6 months follow-up

Secondary Outcomes

bleeding

Data from ClinicalTrials.gov

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