Safety of a Diagnostic Strategy With D-Dimer Testing for PE

Venous Thromboembolism Clinical Trial

Official title:

A Cohort Study Evaluating the Safety of a Diagnostic Strategy Involving D-Dimer Testing in Patients With Suspected Pulmonary Embolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00182221
• Other study ID #: CTMG-2005-SIMPLE
• Secondary ID: Grant #NA 5154
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: March 28, 2017
• Start date: August 2003
• Est. completion date: April 2008

Study information

• Verified date: March 2017
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine whether D-Dimer testing, using the MDA D-Dimer assay, can be used to simplify the diagnostic process for pulmonary embolism (PE). This will be assessed by performing a cohort study in 1000 patients with suspected PE.

To ascertain if an MDA D-Dimer result of less than 0.75 ug/mL FEU obviates the need for further testing and therapy in patients with suspected PE.

Description:

Prospective cohort study of 1000 patients in which those with a negative D-Dimer result undergo no further testing and are followed for 3 months for venous thromboembolism. Patients with a positive D-Dimer undergo standardized testing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: April 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 years or older

• Suspected PE

Exclusion Criteria:

• Treatment with full-dose anticoagulants for 24 hours or more OR an ongoing requirement for anticoagulants

• Other tests for PE performed prior to eligibility assessment (e.g.other D-Dimer, V/Q scan, pulmonary angiogram, spiral CT, compression ultrasound, venogram).

• Cardiorespiratory instability requiring immediate performance of other tests to diagnose or exclude PE (i.e. inability to wait 30-60 minutes for MDA D-Dimer result)

• Comorbid condition limiting survival to less than three months

• Patient has been asymptomatic for seven days prior to presentation

• Current pregnancy

• Contraindication to contrast (e.g., allergy, renal failure).

• Geographic in accessibility which precludes follow-up

• Presence of central venous catheter (permanent or temporary, including PICC line) at the time of eligibility assessment

Related Conditions & MeSH terms

• Pulmonary Embolism
• Thromboembolism
• Venous Thromboembolism

Intervention

Procedure:
• MDA D-Dimer Testing

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences, General	Hamilton	Ontario
Canada	Hamilton Health Sciences-Henderson Campus	Hamilton	Ontario
Canada	Hamilton Health Sciences-McMaster Campus	Hamilton	Ontario
Canada	St Joseph's Health Care Centre	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Heart and Stroke Foundation of Ontario

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Venousthromboembolism		3 months