PERCEPIC: PERC Rule Combined With Implicit Low Clinical Probability

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

COMPLETED

Total Enrollment

1773 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-07-31

Brief Summary

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PERC rule was created to rule out pulmonary embolism (PE) without further exams, with residual PE risk \<2%. Its safety is currently confirmed in low PE prevalence populations as north-American. In European high PE prevalence population, it has been showed that PERC rule used alone or associated with low clinical probability assessed by revised Geneva score (RGS) was not safe. In retrospective study, we suggest that the combination of PERC rule with implicit clinical probability (gestalt) could allow the use of the PERC rule.

PERCEPIC, an observational prospective multicenter study performed in France and Belgium, will test this hypothesis. Therefore, 3000 patients will be included in 12 centers. Primary outcome will be the rate of thromboembolic events or death related or possibly related to PE in patients with low implicit clinical probability and negative PERC rule (8 criteria absents). Upper limit of confidence interval of this rate must be equal or lower than 3% to consider PERC rule as safe in this combination.

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Detailed Description

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Conditions

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Pulmonary Embolism Dyspnea Thoracic Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Gestalt estimation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\- Patients admitted to the emergency department for one of the following criteria :

* Dyspnea and/or Thoracic pain without another obvious cause
* Pulmonary embolism suspicion whatever the reason

Exclusion Criteria

* Age lower than 18
* Patients hospitalized for more than 48h
* Ongoing curative anticoagulant therapy for more than 48h before admission
* Patients with thromboembolic disease diagnosed before the admission
* Unavailability for follow-up (short life expectancy, no phone number…)
* Patient refusing to be contacted by phone at 3 month
* Patient refusing that medical data were collected

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No