Clinical Trial: Age-adjusted D-dimer Cut-off Levels to Rule Out Pulmonary Embolism

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Age-adjusted D-dimer Cut-off Levels to Rule Out Pulmonary Embolism: a Prospective Outcome Study.

Brief Summary:

Suspected pulmonary embolism (PE) is a frequent clinical problem and remains a diagnostic challenge. The diagnostic approach of PE relies on sequential diagnostic tests, such as plasma D-dimer measurement, multi-slice computed tomography (MSCT) and pulmonary angiography. In addition, the diagnostic workup is usually stratified according to the clinical probability of pulmonary embolism. Clinical probability has a fair predictive accuracy either evaluated implicitly or by clinical prediction rules1 and is useful for identifying patients with a low prevalence of pulmonary embolism who can be usually fully investigated by non invasive tests.The D-dimer test has been extensively evaluated in the exclusion of pulmonary embolism, particularly in outpatients. ELISA D-dimer and second-generation latex agglutination (immuno-turbidimetric tests) have a remarkably high sensitivity and have been proved safe first-line tests in association with clinical probability to rule out pulmonary embolism in outcome studies. The clinical usefulness of D-dimer is defined by the proportion of patients in whom pulmonary embolism may be ruled out by a normal result and it is determined by the specificity. However, ELISA and second-generation latex agglutination (immuno-turbidimetric tests) tests have a quite limited overall specificity of around 35% to 40%. Therefore, many investigators tried to increase the D-dimer thresholds in particular in elderly patients to increase the rate of patients in whom the diagnosis could be excluded by this easy and inexpensive test. Several studies have shown that D-dimer levels increase with age and which turns in a decreased specificity of the D-dimer test at the usual threshold in the elderly, and thus to a less useful test to exclude PE in older patients. Indeed, ELISA D-dimer is able to rule out PE in 60% of patients aged less than 40 years, but in only 5% of patients above the age of 80.8 In this study, rais

Detailed Summary:
Sponsor: Marc Righini

Current Primary Outcome: The main outcome is the rate of thromboembolic events during a formal 3-month follow-up in patients not anticoagulated on the basis of a PE ruled out by the association mentioned here above. [ Time Frame: 3 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Prospective validation of the simplified revised Geneva score. [ Time Frame: 3 years ]

Original Secondary Outcome: Same as current

Information By: University Hospital, Geneva

Dates:
Date Received: May 28, 2010
Date Started: October 2010
Date Completion:
Last Updated: May 27, 2015
Last Verified: April 2013