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

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

MDA D-Dimer Testing

About this trial

This is an interventional diagnostic trial for Venous Thromboembolism focused on measuring Pulmonary Embolism, Deep Vein Thrombosis, MDA D-Dimer Testing, Diagnostic Algorithm

Eligibility Criteria

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

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

Sites / Locations

St Joseph's Health Care Centre
Hamilton Health Sciences-Henderson Campus
Hamilton Health Sciences-McMaster Campus
Hamilton Health Sciences, General

Outcomes

Primary Outcome Measures

Venousthromboembolism

Secondary Outcome Measures

Full Information

NCT ID

NCT00182221

First Posted

September 13, 2005

Last Updated

March 28, 2017

Sponsor

McMaster University

Collaborators

Heart and Stroke Foundation of Ontario

1. Study Identification

Unique Protocol Identification Number

NCT00182221

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

August 2003 (undefined)

Primary Completion Date

February 2008 (Actual)

Study Completion Date

April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

McMaster University

Collaborators

Heart and Stroke Foundation of Ontario

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

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

Venous Thromboembolism

Keywords

Pulmonary Embolism, Deep Vein Thrombosis, MDA D-Dimer Testing, Diagnostic Algorithm

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

1000 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

MDA D-Dimer Testing

Primary Outcome Measure Information:

Title

Venousthromboembolism

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shannon M Bates, MDCM,MSc

Organizational Affiliation

Hamilton Health Sciences Corporation

Official's Role

Principal Investigator

Facility Information:

Facility Name

St Joseph's Health Care Centre

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 4A6

Country

Canada

Facility Name

Hamilton Health Sciences-Henderson Campus

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8V !C3

Country

Canada

Facility Name

Hamilton Health Sciences-McMaster Campus

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8V 1C3

Country

Canada

Facility Name

Hamilton Health Sciences, General

City

Hamilton

State/Province

Ontario

Country

Canada

Venous Thromboembolism

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial