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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1
Emergency department Hospital Pitié-Salpêtrière
Paris, France, 75013
2
Emergency department
Barcelona, Spain