PERCEPIC: PERC Rule Combined With Implicit Low Clinical Probability (PERCEPIC)

• ClinicalTrials.gov Identifier: NCT02360540
• Recruitment Status: Completed
• First Posted: February 10, 2015
• Last Update Posted: September 22, 2016
• Sponsor: University Hospital, Angers
• Collaborator: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Information provided by (Responsible Party): University Hospital, Angers

Study Description

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.

Condition or disease	Intervention/treatment
Pulmonary Embolism; Dyspnea; Thoracic Pain	Other: Gestalt estimation

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 1773 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 3 Months
• 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 Start Date: May 2015
• Actual Primary Completion Date: July 2016
• Actual Study Completion Date: July 2016

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. To assess the accuracy of the combination of low implicit clinical probability (gestalt) and negative PERC rule (8 criteria absents) [ Time Frame: 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 :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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

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.

Contacts and Locations

Locations

Belgium

Clinique Universitaire Saint-Luc

Bruxelles, Belgium

UH Erasme

Bruxelles, Belgium

UH Liège

Liège, Belgium

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, France

Sponsors and Collaborators

University Hospital, Angers

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

• Study Chair: Pierre-Marie ROY, MD-PhD; UH Angers
• Study Director: Andréa PENALOZA, MD-PhD; Clinique Universitaire Saint-Luc, Bruxelles

More Information

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University Hospital, Angers
• ClinicalTrials.gov Identifier: NCT02360540
• Other Study ID Numbers: PHRC2014_02
• First Posted: February 10, 2015
• Last Update Posted: September 22, 2016
• Last Verified: September 2016

Keywords provided by University Hospital, Angers:

Pulmonary Embolism; Diagnostic strategy; Exclusion; Clinical probability; Implicit Judgment (Gestalt); PERC

Additional relevant MeSH terms:

Pulmonary Embolism; Dyspnea; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory