Safety of a Diagnostic Strategy With D-Dimer Testing for PE
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.
Study Design
Allocation: Non-Randomized, Control: Historical Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Conditions
Venous Thromboembolism
Intervention
MDA D-Dimer Testing
Location
Hamilton Health Sciences-McMaster Campus
Hamilton
Ontario
Canada
L8V 1C3
Status
Completed
Source
McMaster University
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00182221
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Venous Insufficiency
Impaired venous blood flow or venous return (venous stasis), usually caused by inadequate venous valves. Venous insufficiency often occurs in the legs, and is associated with EDEMA and sometimes with VENOUS STASIS ULCERS at the ankle.
Venous Thromboembolism
Obstruction of a vein or VEINS (embolism) by a blood clot (THROMBUS) in the blood stream.
Intermittent Pneumatic Compression Devices
Instruments that generate intermittent forces, uniformed or graduated, to facilitate the emptying of VEINS. These devices are used to reduce limb EDEMA and prevent venous THROMBOEMBOLISM, such as deep vein thrombosis in the legs.
Genetic Testing
Detection of or testing for certain ALLELES, mutations, genotypes, or karyotypes that are associated with genetic traits, heritable diseases, or with a predisposition to a disease, or that may lead to the disease in descendants. It includes prenatal genetic testing.
Anonymous Testing
Testing in which the source of the specimen or the person being tested is not individually identified.
Clinical Trials
D-Dimer to Predict Recurrence in Patients With Multiple Episodes of Venous Thromboembolism
Optimal duration of oral anticoagulant therapy in patients with recurrent episodes of venous thromboembolism (VTE) is a matter of debate and recommendations are based on inadequate evidenc...
The purpose of this study is to determine if the risk of recurrent venous thromboembolism (VTE) after stopping therapy is low and acceptable in patients with a first unprovoked proximal de...
The results of the Prolong study, currently submitted for publication, show that patients with a first unprovoked venous thromboembolic event who have altered D-dimer levels, measured one...
D-Dimer Guided Oral Anticoagulant Treatment (OAT)
This clinical trial will investigate the hypothesis that D-Dimer testing can be successfully used to tailor the duration of OAT in patients after an unprovoked episode of deep venous throm...
Fetal Loss in Women With Unprovoked Thromboembolism (FLUTE)
The purpose of this study is to determine the risk of fetal loss in women with unprovoked venous thromboembolism (VTE) who do not have identifiable inherited thrombophilia compared with wo...
PubMed Articles
Aspirin for preventing venous thromboembolism.
To the Editor: In their report on the Aspirin to Prevent Recurrent Venous Thromboembolism (ASPIRE) trial, Brighton et al. (Nov. 22 issue)(1) describe a nonsignificant decrease in the rate of recurrent...
Aspirin for preventing venous thromboembolism.
To the Editor: In their report on the Aspirin to Prevent Recurrent Venous Thromboembolism (ASPIRE) trial, Brighton et al. (Nov. 22 issue)(1) describe a nonsignificant decrease in the rate of recurrent...
Aspirin for preventing venous thromboembolism.
To the Editor: In their report on the Aspirin to Prevent Recurrent Venous Thromboembolism (ASPIRE) trial, Brighton et al. (Nov. 22 issue)(1) describe a nonsignificant decrease in the rate of recurrent...
Aspirin for preventing the recurrence of venous thromboembolism.
About 20% of patients with unprovoked venous thromboembolism have a recurrence within 2 years after the withdrawal of oral anticoagulant therapy. Extending anticoagulation prevents recurrences but is...
Invited commentary: diet and risk of venous thromboembolism--a hard nut to crack.
Recently, there has been interest in determining whether diet is associated with the risk of venous thromboembolism. The article by Varraso et al. (Am J Epidemiol. 2012;175(2):114-126) published in th...
