Canadian Pulmonary Embolism Diagnosis Study (CANPEDS)

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

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

1126 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-08-31

Study Completion Date

2001-01-31

Brief Summary

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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

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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.

Conditions

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Suspected Pulmonary Embolism Deep Venous Thrombosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Two diagnostic management strategies

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Canada

Other Identifiers

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CIHR-CANPEDS

Identifier Type: -

Identifier Source: secondary_id

CTMG-1999-CANPEDS

Identifier Type: -

Identifier Source: org_study_id

Canadian Pulmonary Embolism Diagnosis Study (CANPEDS)

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Interventions

Two diagnostic management strategies

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Canadian Institutes of Health Research (CIHR)

Hamilton Health Sciences Corporation

Principal Investigators

Clive Kearon, MD, PhD

Jeffrey S Ginsberg, MD

James Douketis, MD

Alexander G Turpie, MB

Shannon M Bates, MDCM

Mark A Crowther, MD

Jeffrey I Weitz, MD

Michael Gent, DSc

Agnes Y Lee, MD

Locations

Queen Elizabeth II Health Sciences Ctr.

Alexander G. Turpie

McMaster University Medical Centre

James Douketis

HHSC Henderson Campus

London Health Sciences Centre

Ottawa Civic Hospitals

Countries

Other Identifiers

CIHR-CANPEDS

CTMG-1999-CANPEDS