Canadian Pulmonary Embolism Diagnosis Study (CANPEDS)

NCT00182546 | Terminated Phase 3

• 2 other identifiers: CTMG-1999-CANPEDSCIHR-CANPEDS
• Study Type: interventional
• Target: 1,126
• Locations: 1 country
• Sites: 7

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

Conditions

Suspected Pulmonary Embolism; Deep Venous Thrombosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• DVT or PE during 6 months follow-up

Secondary Outcomes (1)

• bleeding

Interventions

Two diagnostic management strategies PROCEDURE

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with clinically suspected PE

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (7)

Queen Elizabeth II Health Sciences Ctr.

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Alexander G. Turpie

Hamilton, Ontario, L8L 2X2, Canada

Location

McMaster University Medical Centre

Hamilton, Ontario, L8N 3Z5, Canada

Location

James Douketis

Hamilton, Ontario, L8N 4A6, Canada

Location

HHSC Henderson Campus

Hamilton, Ontario, L8V 1C3, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 4G5, Canada

Location

Ottawa Civic Hospitals

Ottawa, Ontario, K1Y 1J8, Canada

Location

MeSH Terms

Conditions

Venous Thrombosis; Pulmonary Embolism; Thrombosis; Disease

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Clive Kearon, MD, PhD

  McMaster University

  STUDY CHAIR

• Jeffrey S Ginsberg, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

• James Douketis, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Alexander G Turpie, MB

  McMaster University

  PRINCIPAL INVESTIGATOR

• Shannon M Bates, MDCM

  McMaster University

  PRINCIPAL INVESTIGATOR

• Mark A Crowther, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Jeffrey I Weitz, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Michael Gent, DSc

  McMaster University

  PRINCIPAL INVESTIGATOR

• Agnes Y Lee, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: August 1, 1998
• Study Completion: January 1, 2001
• Last Updated: May 3, 2006

Record last verified: 2005-08

Locations

CA (7)