Clinical trial NCT02360540: PERCEPIC: PERC Rule Combined With Implicit Low Clinical Probability
Official title: Performance of the Pulmonary Embolism Rule-out Criteria (the PERC Rule) Combined With Implicit Low Clinical Probability (Gestalt) to Rule-out PE Without Further Exams
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Embolism
Dyspnea
Thoracic Pain
Keywords: Pulmonary Embolism
Diagnostic strategy
Exclusion
Clinical probability
Implicit Judgment (Gestalt)
PERC
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
Collaborators: name: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
First posted: 2015-02-10
Enrollment: 1773
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted to the emergency department for dyspnea or thoracic pain without another obvious cause or suspected PE

Brief 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 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
* Secondary exclusion criteria : curative anticoagulant therapy for more than 5 days during the 3 month follow-up for another reason than thromboembolic disease.

Primary outcomes:
measure: To assess the accuracy of the combination of low implicit clinical probability (gestalt) and negative PERC rule (8 criteria absents)
timeFrame: 3 months
Secondary outcomes:
measure: To assess usefulness of PERC and implicit low clinical probability combination to reduce the use of further exams
timeFrame: During emergency managment
measure: To assess the accuracy of PERC and low clinical probability combination depending of clinical probability assessment method (implicit assessment, revised Geneva Score, Wells Score and implicit overridden Geneva Score)
timeFrame: 3 months
measure: To compare performances of clinical probability assessment methods : implicit assessment, revised Geneva Score, Wells Score and implicit overridden Geneva Score
timeFrame: 3 months
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Clinique Universitaire Saint-Luc
city: Bruxelles
country: Belgium
facility: UH Erasme
city: Liège
country: Belgium
facility: UH Liège
city: Agen
country: France
facility: Hospital of Agen
city: Angers
country: France
facility: UH Angers
city: Argenteuil
country: France
facility: Hospital of Argenteuil
city: Clermont-Ferrand
country: France
facility: UH Clermont-Ferrand
city: Le Mans
country: France
facility: Hospital of Le Mans
city: Nantes
country: France
facility: UH Nantes
city: Poitiers
country: France
facility: UH Poitiers
city: Rennes
country: France
facility: UH Rennes
city: Saint-Brieuc
country: France
facility: Hospital of Saint-Brieuc
Study officials:
affiliation: UH Angers
name: Pierre-Marie ROY, MD-PhD
role: STUDY_CHAIR
affiliation: Clinique Universitaire Saint-Luc, Bruxelles
name: Andréa PENALOZA, MD-PhD
role: STUDY_DIRECTOR
References:
citation: Penaloza A, Soulie C, Moumneh T, Delmez Q, Ghuysen A, El Kouri D, Brice C, Marjanovic NS, Bouget J, Moustafa F, Trinh-Duc A, Le Gall C, Imsaad L, Chretien JM, Gable B, Girard P, Sanchez O, Schmidt J, Le Gal G, Meyer G, Delvau N, Roy PM. Pulmonary embolism rule-out criteria (PERC) rule in European patients with low implicit clinical probability (PERCEPIC): a multicentre, prospective, observational study. Lancet Haematol. 2017 Dec;4(12):e615-e621. doi: 10.1016/S2352-3026(17)30210-7. Epub 2017 Nov 14.