Age-adjusted D-dimer Cut-off to Rule Out Pulmonary Embolism in the Emergency Department : A Real Life Impact Study

NCT02601846 | Completed

• 1 other identifier: Geneva 15-010
• Study Type: observational
• Target: 1,507
• Locations: 3 countries
• Sites: 10

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.

Conditions

Pulmonary Embolism

Outcome Measures

Primary Outcomes (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

  Adjudicated objectively confirmed pulmonary embolism and/or deep vein thrombosis

  Three months

Secondary Outcomes (1)

• Additional diagnostic yield of the age-adjusted D-dimer cut-off compared with the standard cut-off of 500µg/L

  Three months

Interventions

No intervention OTHER

This is an observational study, without any specific intervention.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Consecutive out patients with suspected PE in whom PE has been considered ruled out by negative D-dimers using an age-adjusted cut-off.

You may not qualify if:

• Life expectancy less than 3 months.
• Geographic inaccessibility for follow-up.
• Therapeutic anticoagulation for any indication.
• Pregnancy.
• Age less than 18.

Sponsors & Collaborators

• University Hospital, Geneva: lead
• University Hospital, Brest: collaborator
• European Georges Pompidou Hospital: collaborator
• University Hospital St Luc, Brussels: collaborator
• Centre Hospitalier Universitaire Vaudois: collaborator
• University Hospital, Angers: collaborator
• Centre Hospitalier d'Agen: collaborator
• University Hospital, Clermont-Ferrand: collaborator

Study Sites (10)

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Location

Albert Trinh-Duc

Agen, France

Location

Angers Univeristy Hospital

Angers, France

Location

Brest University Hospital

Brest, France

Location

Jeannot Schmidt

Clermont-Ferrand, France

Location

Guy Meyer

Paris, France

Location

Hôpital Fribourgeois HFR

Fribourg, Switzerland

Location

Geneva University Hospitals

Geneva, Switzerland

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, Switzerland

Location

Groupement Hospitalier de l'Ouest Lémanique

Nyon, Switzerland

Location

Related Publications (2)

• Righini M, Van Es J, Den Exter PL, Roy PM, Verschuren F, Ghuysen A, Rutschmann OT, Sanchez O, Jaffrelot M, Trinh-Duc A, Le Gall C, Moustafa F, Principe A, Van Houten AA, Ten Wolde M, Douma RA, Hazelaar G, Erkens PM, Van Kralingen KW, Grootenboers MJ, Durian MF, Cheung YW, Meyer G, Bounameaux H, Huisman MV, Kamphuisen PW, Le Gal G. Age-adjusted D-dimer cutoff levels to rule out pulmonary embolism: the ADJUST-PE study. JAMA. 2014 Mar 19;311(11):1117-24. doi: 10.1001/jama.2014.2135.

  PMID: 24643601 BACKGROUND

• Robert-Ebadi H, Robin P, Hugli O, Verschuren F, Trinh-Duc A, Roy PM, Schmidt J, Fumeaux T, Meyer G, Hayoz D, Carron PN, Salaun PY, Sarasin F, Rutschmann O, Le Gal G, Righini M. Impact of the Age-Adjusted D-Dimer Cutoff to Exclude Pulmonary Embolism: A Multinational Prospective Real-Life Study (the RELAX-PE Study). Circulation. 2021 May 4;143(18):1828-1830. doi: 10.1161/CIRCULATIONAHA.120.052780. Epub 2021 May 3. No abstract available.

  PMID: 33939529 DERIVED

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Helia Robert-Ebadi, MD

  Geneva University Hospitals and Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 14, 2015
• First Posted: November 10, 2015
• Study Start: November 1, 2015
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: May 6, 2021

Record last verified: 2021-05

Locations

CH (4); BE (1); FR (5)