Status:

COMPLETED

Modified Strategy to Safely Rule Out Pulmonary Embolism in the Emergency Department

Lead Sponsor:

Assistance Publique - Hôpitaux de Paris

Conditions:

Pulmonary Embolism

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Because a missed PE could be potentially lethal, several researches reported that PE is both overinvestigated and overdiagnosed. The diagnostic gold standard for PE is the computed tomographic pulmona...

Detailed Description

The diagnosis of Pulmonary Embolism (PE) is a crucial matter in the Emergency Department (ED). Because a missed PE could be potentially lethal, several researches reported that PE is both overinvestig...

Eligibility Criteria

Inclusion

  • Patient aged ≥ 18 years that presents to an ED
  • With new onset of or worsening of shortness of breath or chest pain or syncope

Exclusion

  • Opposition to the participation to the study
  • Anticipated inability to follow up at 3 month
  • Other obvious cause than PE for chest pain, syncope or dyspnea
  • High clinical probability of PE (estimated by the physician gestalt as \> 50%) or low clinical probability and PERC negative patients
  • Low clinical probability (estimated by the physician gestalt as \< 15%) and no item of the PERC score (heart rate \> 100, Sa02 \< 95, unilateral leg swelling, hemoptysis, past history of thrombo-embolism, exogen estrogen intake, recent trauma or surgery, age ≥ 50)
  • Acute severe presentation (clinical signs of respiratory distress, hypotension, SpO2\<90%, shock)
  • Concurrent anticoagulation treatment
  • Current diagnosed thrombo-embolic event (in the past 6 months)
  • Prisoners
  • Pregnancy
  • No social security
  • Participation in another intervention trial

Key Trial Info

Start Date :

October 1 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 20 2020

Estimated Enrollment :

1414 Patients enrolled

Trial Details

Trial ID

NCT04032769

Start Date

October 1 2019

End Date

November 20 2020

Last Update

May 3 2021

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Emergency department Hospital Pitié-Salpêtrière

Paris, France, 75013

2

Emergency department

Barcelona, Spain