PERCEPIC: PERC Rule Combined With Implicit Low Clinical Probability

Pulmonary Embolism Clinical Trial

— PERCEPIC  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02360540
• Other study ID #: PHRC2014_02
• Status: Completed
• Phase: N/A
• First received: February 5, 2015
• Last updated: September 21, 2016
• Start date: May 2015
• Est. completion date: July 2016

Study information

• Verified date: September 2016
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: Commission nationale de l'informatique et des libertés
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1773
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chest Pain
• Dyspnea
• Embolism
• Pulmonary Embolism
• Thoracic Pain

Intervention

Other:
• Gestalt estimation

Locations

Country	Name	City	State
Belgium	Clinique Universitaire Saint-Luc	Bruxelles
Belgium	UH Erasme	Bruxelles
Belgium	UH Liège	Liège
France	Hospital of Agen	Agen
France	UH Angers	Angers
France	Hospital of Argenteuil	Argenteuil
France	UH Clermont-Ferrand	Clermont-Ferrand
France	Hospital of Le Mans	Le Mans
France	UH Nantes	Nantes
France	UH Poitiers	Poitiers
France	UH Rennes	Rennes
France	Hospital of Saint-Brieuc	Saint-Brieuc

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Angers	Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the accuracy of the combination of low implicit clinical probability (gestalt) and negative PERC rule (8 criteria absents)	Rate of thromboembolic events or death related or possibly related to PE in patients with low implicit clinical probability and negative PERC rule. Upper limit of confidence interval of this rate must be equal or lower than 3% to consider PERC rule as safe in this combination	3 months	Yes
Secondary	To assess usefulness of PERC and implicit low clinical probability combination to reduce the use of further exams	Mean number of further exams performed per diagnostic strategy	During emergency managment	No
Secondary	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)	For each methods, AUC in receiver operating characteristic analyses of the 3-level classification scheme will be compared.	3 months	No
Secondary	To compare performances of clinical probability assessment methods : implicit assessment, revised Geneva Score, Wells Score and implicit overridden Geneva Score	For each methods, AUC in receiver operating characteristic analyses of the 3-level classification scheme will be compared	3 months	No