Back to results

Canadian Pulmonary Embolism Diagnosis Study (CANPEDS)

Primary Purpose

Suspected Pulmonary Embolism, Deep Venous Thrombosis

Status

Terminated

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

Two diagnostic management strategies

About this trial

This is an interventional treatment trial for Suspected Pulmonary Embolism focused on measuring Pulmonary Embolism, DVT, Venous Thrombosis, D dimer, DD, Thrombosis, Diagnosis

Eligibility Criteria

0 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / 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

Outcomes

Primary Outcome Measures

DVT or PE during 6 months follow-up

Secondary Outcome Measures

bleeding

Full Information

NCT ID

NCT00182546

First Posted

September 13, 2005

Last Updated

April 27, 2006

Sponsor

Hamilton Health Sciences Corporation

Collaborators

Canadian Institutes of Health Research (CIHR)

1. Study Identification

Unique Protocol Identification Number

NCT00182546

Brief Title

Canadian Pulmonary Embolism Diagnosis Study (CANPEDS)

Official Title

Canadian Pulmonary Embolism Diagnosis Study

Study Type

Interventional

2. Study Status

Record Verification Date

August 2005

Overall Recruitment Status

Terminated

Study Start Date

August 1998 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

January 2001 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Hamilton Health Sciences Corporation

Collaborators

Canadian Institutes of Health Research (CIHR)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Suspected Pulmonary Embolism, Deep Venous Thrombosis

Keywords

Pulmonary Embolism, DVT, Venous Thrombosis, D dimer, DD, Thrombosis, Diagnosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1126 (false)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Two diagnostic management strategies

Primary Outcome Measure Information:

Title

DVT or PE during 6 months follow-up

Secondary Outcome Measure Information:

Title

bleeding

10. Eligibility

Sex

All

Minimum Age & Unit of Time

0 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials: