Safety of a Diagnostic Strategy With D-Dimer Testing for PE
This study has been completed.
Sponsor:
Hamilton Health Sciences Corporation
Collaborator:
Heart and Stroke Foundation of Ontario
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00182221
First received: September 13, 2005
Last updated: April 18, 2008
Last verified: April 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Venous Thromboembolism |
Procedure: MDA D-Dimer Testing |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | A Cohort Study Evaluating the Safety of a Diagnostic Strategy Involving D-Dimer Testing in Patients With Suspected Pulmonary Embolism |
Resource links provided by NLM:
Further study details as provided by McMaster University:
Primary Outcome Measures:
- Venousthromboembolism [ Time Frame: 3 months ]
| Estimated Enrollment: | 1000 |
| Study Start Date: | August 2003 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00182221
Locations
| Canada, Ontario | |
| Hamilton Health Sciences-McMaster Campus | |
| Hamilton, Ontario, Canada, L8V 1C3 | |
| Hamilton Health Sciences-Henderson Campus | |
| Hamilton, Ontario, Canada, L8V !C3 | |
| St Joseph's Health Care Centre | |
| Hamilton, Ontario, Canada, L8N 4A6 | |
| Hamilton Health Sciences, General | |
| Hamilton, Ontario, Canada | |
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Heart and Stroke Foundation of Ontario
Investigators
| Principal Investigator: | Shannon M Bates, MDCM,MSc | Hamilton Health Sciences Corporation |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00182221 History of Changes |
| Other Study ID Numbers: | CTMG-2005-SIMPLE, Grant #NA 5154 |
| Study First Received: | September 13, 2005 |
| Last Updated: | April 18, 2008 |
| Health Authority: | Canada: Health Canada |
Keywords provided by McMaster University:
|
Pulmonary Embolism Deep Vein Thrombosis MDA D-Dimer Testing Diagnostic Algorithm |
Additional relevant MeSH terms:
|
Pulmonary Embolism Thromboembolism Venous Thromboembolism Venous Thrombosis Lung Diseases Respiratory Tract Diseases Embolism Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases |
Thrombosis Fibrin fragment D Antifibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Hemostatics Coagulants Hematologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013