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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
Sponsor:
Collaborators:
University Hospital, Brest
European Georges Pompidou Hospital
University Hospital St Luc, Brussels
Centre Hospitalier Universitaire Vaudois
University Hospital, Angers
Centre Hospitalier d'Agen
University Hospital, Clermont-Ferrand
Information provided by (Responsible Party):
Helia Robert-Ebadi, University Hospital, Geneva

Brief Summary:

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

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Study Type : Observational
Actual Enrollment : 1507 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
Actual Primary Completion Date : June 2019
Actual Study Completion Date : June 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: No intervention
    This is an observational study, without any specific intervention.


Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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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
Study Population
All consecutive patients admitted to the emergency department with suspected PE defined as acute onset of new or worsening shortness of breath or chest pain without any other obvious etiology in whom PE has been considered ruled out by negative D-dimers using an age-adjusted cut-off will be screened for inclusion. Those with non-high probability and negative D-dimer (PE excluded by the non-invasive strategy using "new" D-dimer cut-off) will be included and followed-up for 3 months. The aim of including both patients above and under 50 years of age is to be able to compare the difference in thromboembolic event rates between patients with a D-dimer level between 500 µg/L and their age-ajusted cut-off and those with a D-dimer < 500 µg/L.
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium
France
Albert Trinh-Duc
Agen, France
Angers Univeristy Hospital
Angers, France
Brest University Hospital
Brest, France
Jeannot Schmidt
Clermont-Ferrand, France
Guy Meyer
Paris, France
Switzerland
Hôpital Fribourgeois HFR
Fribourg, Switzerland
Geneva University Hospitals
Geneva, Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland
Groupement Hospitalier de l'Ouest Lémanique
Nyon, Switzerland
Sponsors and Collaborators
University Hospital, Geneva
University Hospital, Brest
European Georges Pompidou Hospital
University Hospital St Luc, Brussels
Centre Hospitalier Universitaire Vaudois
University Hospital, Angers
Centre Hospitalier d'Agen
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Helia Robert-Ebadi, MD Geneva University Hospitals and Faculty of Medicine
Publications:
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Responsible Party: Helia Robert-Ebadi, Principal Investigator, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT02601846    
Other Study ID Numbers: Geneva 15-010
First Posted: November 10, 2015    Key Record Dates
Last Update Posted: May 6, 2021
Last Verified: May 2021
Additional relevant MeSH terms:
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Pulmonary Embolism
Embolism
Emergencies
Disease Attributes
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases