Canadian Pulmonary Embolism Diagnosis Study (CANPEDS)

Deep Venous Thrombosis Clinical Trial

Official title:

Canadian Pulmonary Embolism Diagnosis Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00182546
• Other study ID #: CTMG-1999-CANPEDS
• Secondary ID: CIHR-CANPEDS
• Status: Terminated
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: April 27, 2006
• Start date: August 1998
• Est. completion date: January 2001

Study information

• Verified date: August 2005
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1126
• Est. completion date: January 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deep Venous Thrombosis
• Embolism
• Pulmonary Embolism
• Suspected Pulmonary Embolism
• Thrombosis
• Venous Thrombosis

Intervention

Procedure:
• Two diagnostic management strategies

Locations

Country	Name	City	State
Canada	Queen Elizabeth II Health Sciences Ctr.	Halifax	Nova Scotia
Canada	Alexander G. Turpie	Hamilton	Ontario
Canada	HHSC Henderson Campus	Hamilton	Ontario
Canada	James Douketis	Hamilton	Ontario
Canada	McMaster University Medical Centre	Hamilton	Ontario
Canada	London Health Sciences Centre	London	Ontario
Canada	Ottawa Civic Hospitals	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DVT or PE during 6 months follow-up
Secondary	bleeding