PERCEPIC: PERC Rule Combined With Implicit Low Clinical Probability

Completed

• Conditions: Pulmonary Embolism; Dyspnea; Thoracic Pain

• Registration Number: NCT02360540
• Lead Sponsor: University Hospital, Angers

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-05
• Study First Submitted QC: 2015-02-09
• Study First Posted: 2015-02-10
• Study Start: 2015-05
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-21
• Last Update Posted: 2016-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1773

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the accuracy of the combination of low implicit clinical probability (gestalt) and negative PERC rule (8 criteria absents)	3 months	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

Secondary Outcome Measures

Name	Time	Method
To assess usefulness of PERC and implicit low clinical probability combination to reduce the use of further exams	During emergency managment	Mean number of further exams performed per diagnostic strategy
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)	3 months	For each methods, AUC in receiver operating characteristic analyses of the 3-level classification scheme will be compared.
To compare performances of clinical probability assessment methods : implicit assessment, revised Geneva Score, Wells Score and implicit overridden Geneva Score	3 months	For each methods, AUC in receiver operating characteristic analyses of the 3-level classification scheme will be compared

Trial Locations

Locations (12)

Clinique Universitaire Saint-Luc; 🇧🇪 Bruxelles, Belgium

UH Liège; 🇧🇪 Liège, Belgium

Hospital of Agen; 🇫🇷 Agen, France

UH Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

UH Angers; 🇫🇷 Angers, France

Hospital of Argenteuil; 🇫🇷 Argenteuil, France

UH Nantes; 🇫🇷 Nantes, France

UH Poitiers; 🇫🇷 Poitiers, France

UH Rennes; 🇫🇷 Rennes, France

Hospital of Le Mans; 🇫🇷 Le Mans, France

Hospital of Saint-Brieuc; 🇫🇷 Saint-Brieuc, France

UH Erasme; 🇧🇪 Bruxelles, Belgium