Clinical trial NCT00182546: Canadian Pulmonary Embolism Diagnosis Study (CANPEDS)
Official title: Canadian Pulmonary Embolism Diagnosis Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Suspected Pulmonary Embolism
Deep Venous Thrombosis
Keywords: Pulmonary Embolism
DVT
Venous Thrombosis
D dimer
DD
Thrombosis
Diagnosis
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2005-09-16
Enrollment: 1126
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: DVT or PE during 6 months follow-up
Secondary outcomes:
measure: bleeding
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Ctr.
state: Nova Scotia
city: Hamilton
country: Canada
facility: Alexander G. Turpie
state: Ontario
city: Hamilton
country: Canada
facility: McMaster University Medical Centre
state: Ontario
city: Hamilton
country: Canada
facility: James Douketis
state: Ontario
city: Hamilton
country: Canada
facility: HHSC Henderson Campus
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Civic Hospitals
state: Ontario
Study officials:
affiliation: McMaster University
name: Clive Kearon, MD, PhD
role: STUDY_CHAIR
affiliation: McMaster University
name: Jeffrey S Ginsberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: James Douketis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Alexander G Turpie, MB
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Shannon M Bates, MDCM
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Mark A Crowther, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Jeffrey I Weitz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Michael Gent, DSc
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Agnes Y Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: