Influence of Diagnostic Errors on the Prognosis of Acute Pulmonary Embolism

• Conditions: Embolism; Diagnostic Errors; Pulmonary Vascular Disorder; Pulmonary Embolism; Pulmonary Embolism and Thrombosis
• Interventions: Other: Diagnostic error

• Registration Number: NCT03101384
• Lead Sponsor: European Georges Pompidou Hospital

Brief Summary

Diagnostic errors have been reported frequently in patient with pulmonary embolism since symptoms are not specific. However, there is only scarce evidence that the delay associated with diagnostic errors may impact patient prognosis. The aim of this study is to determine the frequency of diagnostic errors and if they are associated with more severe pulmonary embolism in term of initial presentation and complications.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-29
• Study First Submitted QC: 2017-03-29
• Study First Posted: 2017-04-05
• Study Start: 2017-04-11
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-01
• Last Update Posted: 2017-06-02
• Primary Completion: 2018-10
• Study Completion: 2019-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 302

Inclusion Criteria

• 18 years and older
• Episode of symptomatic acute pulmonary embolism objectively proven

Exclusion Criteria

• Below 18 years of age
• Patient chronically receiving therapeutic anticoagulation
• Pulmonary embolism complicating a current hospitalisation for another medical reason
• Asymptomatic pulmonary embolism

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient with a diagnostic error	Diagnostic error	Defined by one of : 1. Absence of prescribed test included in an accepted pulmonary diagnosis algorithm in the next 48h00 after the firts contact with a physician 2. Absence of prescribed test included in an accepted pulmonary diagnosis algorithm by the first contacted physician but the diagnostic is done before 48h00 because the patient went at the emergency room on his own initiative. 3. More than one doctor consulted before the diagnostic of pulmonary embolism (excluding the emergency physician if the patient was referred by the 1st contact doctor)

Primary Outcome Measures

Name	Time	Method
Severity of pulmonary embolism at the time of diagnosis	Day 1	According to the 2014 Europe Society of Cardiology classification that combine clinical characteristics, signs of right ventricular dysfunction on imaging test and cardiac laboratory biomarkers

Secondary Outcome Measures

Name	Time	Method
Frequency of diagnostic errors	Day 1	Frequency of diagnostic errors
Complication of pulmonary embolism	Day 30 and 180	Composite of death, shock and recurrence
Characteristic of patient with diagnosis errors	Day 30	Characteristic of patient with diagnosis errors

Trial Locations

Locations (1)

Hôpital européen Georges Pompidou; 🇫🇷 Paris, Ile de France, France