Influence of Diagnostic Errors on the Prognosis of Acute Pulmonary Embolism

NCT ID: NCT03101384

Last Updated: 2017-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

302 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-11

Study Completion Date

2019-04-30

Brief Summary

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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

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Conditions

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Pulmonary Embolism Pulmonary Embolism and Thrombosis Diagnostic Errors Embolism Pulmonary Vascular Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient with a 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)

Diagnostic error

Intervention Type OTHER

There is no intervention in our study. Patient will be managed with usual care. We will divide patients in the 2 groups according to the presence of diagnostic error.

Patient without a diagnostic error

Any patient that did not meet the criteria to define the diagnostic error

No interventions assigned to this group

Interventions

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Diagnostic error

There is no intervention in our study. Patient will be managed with usual care. We will divide patients in the 2 groups according to the presence of diagnostic error.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Georges Pompidou Hospital

OTHER

Sponsor Role lead

Responsible Party

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Guy Meyer

Professeur des Universités

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guy Meyer, Pr

Role: PRINCIPAL_INVESTIGATOR

Hôpital Européen Georges Pompidou, AP-HP

Locations

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Hôpital européen Georges Pompidou

Paris, Île-de-France Region, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Guy Meyer, Pr

Role: CONTACT

06 25 50 04 58

Benoit Côté, Md

Role: CONTACT

06 25 50 04 58

Facility Contacts

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Guy Meyer, Pr.

Role: primary

Benoit Côté, Dr.

Role: backup

06 25 50 04 58

Other Identifiers

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N° ID RCB : 2017-A00433-50

Identifier Type: -

Identifier Source: org_study_id

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