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 |
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Recruitment Status :
Recruiting
First Posted : November 10, 2015
Last Update Posted : October 26, 2016
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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 |
Show Detailed Description
| Study Type : | Observational |
| Estimated Enrollment : | 1100 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| 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 |
| Estimated Primary Completion Date : | December 2018 |
| Estimated Study Completion Date : | March 2019 |
- Other: No intervention
This is an observational study, without any specific intervention.
- The incidence of symptomatic thromboembolic events (objectively confirmed pulmonary embolism and/or deep vein thrombosis) during follow-up in patients with D-dimer levels below age-adjusted cutoff [ 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 [ Time Frame: Three months ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
- Consecutive out patients with suspected PE in whom PE has been considered ruled out by negative D-dimers using an age-adjusted cut-off.
Exclusion Criteria:
- Life expectancy less than 3 months.
- Geographic inaccessibility for follow-up.
- Therapeutic anticoagulation for any indication.
- Pregnancy.
- Age less than 18.
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
| Contact: Helia Robert-Ebadi, MD | helia.robert-ebadi@hcuge.ch | ||
| Contact: Marc Righini, MD | marc.righini@hcuge.ch |
| Belgium | |
| Cliniques Universitaires Saint-Luc | Recruiting |
| Brussels, Belgium | |
| Contact: Franck Verschuren, MD franck.verschuren@uclouvain.be | |
| Principal Investigator: Franck Verschuren, MD | |
| CHU de Liège | Recruiting |
| Liege, Belgium | |
| Contact: Alexandre Ghuysen, MD a.ghuysen@chu.ulg.ac.be | |
| Principal Investigator: Alexandre Ghuysen, MD | |
| Switzerland | |
| Hôpital Fribourgeois HFR | Not yet recruiting |
| Fribourg, Switzerland | |
| Contact: Daniel Hayoz, MD Daniel.Hayoz@h-fr.ch | |
| Principal Investigator: Daniel Hayoz, MD | |
| Geneva University Hospitals | Recruiting |
| Geneva, Switzerland | |
| Contact: Helia Robert-Ebadi, MD helia.robert-ebadi@hcuge.ch | |
| Principal Investigator: Helia Robert-Ebadi, MD | |
| Principal Investigator: Marc Righini, MD | |
| Centre Hospitalier Universitaire Vaudois | Recruiting |
| Lausanne, Switzerland | |
| Contact: Olivier Hügli, MD Olivier.Hugli@chuv.ch | |
| Groupement Hospitalier de l'Ouest Lémanique | Recruiting |
| Nyon, Switzerland | |
| Contact: Thierry Fumeaux, MD thierry.fumeaux@ghol.ch | |
| Principal Investigator: Thierry Fumeaux, MD | |
| Principal Investigator: | Helia Robert-Ebadi, MD | Geneva University Hospitals and Faculty of Medicine |
Publications:
| Responsible Party: | Helia Robert-Ebadi, Principal Investigator, University Hospital, Geneva |
| ClinicalTrials.gov Identifier: | NCT02601846 History of Changes |
| Other Study ID Numbers: |
Geneva 15-010 |
| First Posted: | November 10, 2015 Key Record Dates |
| Last Update Posted: | October 26, 2016 |
| Last Verified: | October 2016 |
Additional relevant MeSH terms:
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Emergencies Embolism Pulmonary Embolism Disease Attributes Pathologic Processes Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases |
Lung Diseases Respiratory Tract Diseases Fibrin fragment D Antifibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Hemostatics Coagulants |