Age-adjusted D-dimer Cut-off to Rule Out Pulmonary Embolism in the Emergency Department : A Real Life Impact Study (RELAX-PE)
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|ClinicalTrials.gov Identifier: NCT02601846|
Recruitment Status : Completed
First Posted : November 10, 2015
Last Update Posted : May 6, 2021
A multicentre multinational prospective management outcome study has recently proven the safety of a diagnostic strategy combining clinical probability assessment with an age-adjusted D-dimer cut-off, defined as a value of (age x 10) in patients > 50 years, for ruling out PE in outpatients, with a very low likelihood of subsequent symptomatic VTE. Moreover, this study showed that such a strategy increased the diagnostic yield of D-dimers, as it allowed ruling out PE without further investigation in a significantly higher proportion of patients than when using standard cut-off, particularly so in patients 75 years or older.
The objective of the present study is to confirm in a prospective cohort of "real life" patients the usefulness of the age-adjusted D-dimer cut-off to rule out PE in patients presenting to the emergency department with suspected PE.
|Condition or disease||Intervention/treatment|
|Pulmonary Embolism||Other: No intervention|
|Study Type :||Observational|
|Actual Enrollment :||1507 participants|
|Official Title:||Age-adjusted D-dimer Cut-off to Rule Out Pulmonary Embolism in the Emergency Department : A Real Life Impact Study|
|Study Start Date :||November 2015|
|Actual Primary Completion Date :||June 2019|
|Actual Study Completion Date :||June 2019|
- Other: No intervention
This is an observational study, without any specific intervention.
- The incidence of symptomatic thromboembolic events during follow-up in patients with PE excluded based on a negative D-dimer using the age-adjusted cutoff [ Time Frame: Three months ]Adjudicated objectively confirmed pulmonary embolism and/or deep vein thrombosis
- Additional diagnostic yield of the age-adjusted D-dimer cut-off compared with the standard cut-off of 500µg/L [ Time Frame: Three months ]Proportion of patients with a non-high clinical probability and a D-dimer result between 500µg/L and their age-adjusted cut-off value
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02601846
|Cliniques Universitaires Saint-Luc|
|Angers Univeristy Hospital|
|Brest University Hospital|
|Hôpital Fribourgeois HFR|
|Geneva University Hospitals|
|Centre Hospitalier Universitaire Vaudois|
|Groupement Hospitalier de l'Ouest Lémanique|
|Principal Investigator:||Helia Robert-Ebadi, MD||Geneva University Hospitals and Faculty of Medicine|