PERCEPIC: PERC Rule Combined With Implicit Low Clinical Probability

Last updated: September 21, 2016
Sponsor: University Hospital, Angers
Overall Status: Completed

Phase

N/A

Condition

Lung Injury

Claudication

Deep Vein Thrombosis

Treatment

N/A

Clinical Study ID

NCT02360540
PHRC2014_02
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

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

  • Secondary exclusion criteria : curative anticoagulant therapy for more than 5 daysduring the 3 month follow-up for another reason than thromboembolic disease.

Study Design

Total Participants: 1773
Study Start date:
May 01, 2015
Estimated Completion Date:
July 31, 2016

Connect with a study center

  • Clinique Universitaire Saint-Luc

    Bruxelles,
    Belgium

    Site Not Available

  • UH Erasme

    Bruxelles,
    Belgium

    Site Not Available

  • UH Liège

    Liège,
    Belgium

    Site Not Available

  • Hospital of Agen

    Agen,
    France

    Site Not Available

  • UH Angers

    Angers,
    France

    Site Not Available

  • Hospital of Argenteuil

    Argenteuil,
    France

    Site Not Available

  • UH Clermont-Ferrand

    Clermont-Ferrand,
    France

    Site Not Available

  • Hospital of Le Mans

    Le Mans,
    France

    Site Not Available

  • UH Nantes

    Nantes,
    France

    Site Not Available

  • UH Poitiers

    Poitiers,
    France

    Site Not Available

  • UH Rennes

    Rennes,
    France

    Site Not Available

  • Hospital of Saint-Brieuc

    Saint-Brieuc,
    France

    Site Not Available

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