PERCEPIC: PERC Rule Combined With Implicit Low Clinical Probability

NCT02360540 | Completed

• 1 other identifier: PHRC2014_02
• Study Type: observational
• Target: 1,773
• Locations: 2 countries
• Sites: 12

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.

Conditions

Pulmonary Embolism; Dyspnea; Thoracic Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• To assess usefulness of PERC and implicit low clinical probability combination to reduce the use of further exams

  During emergency managment

• 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

• To compare performances of clinical probability assessment methods : implicit assessment, revised Geneva Score, Wells Score and implicit overridden Geneva Score

  3 months

Interventions

Gestalt estimation OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead
• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: collaborator

Study Sites (12)

Clinique Universitaire Saint-Luc

Brussels, Belgium

Location

UH Erasme

Brussels, Belgium

Location

UH Liège

Liège, Belgium

Location

Hospital of Agen

Agen, France

Location

UH Angers

Angers, France

Location

Hospital of Argenteuil

Argenteuil, France

Location

UH Clermont-Ferrand

Clermont-Ferrand, France

Location

Hospital of Le Mans

Le Mans, France

Location

UH Nantes

Nantes, France

Location

UH Poitiers

Poitiers, France

Location

UH Rennes

Rennes, France

Location

Hospital of Saint-Brieuc

Saint-Brieuc, France

Location

Related Publications (1)

• 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.

  PMID: 29150390 DERIVED

MeSH Terms

Conditions

Pulmonary Embolism; Dyspnea; Chest Pain

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations

Study Officials

• Pierre-Marie ROY, MD-PhD

  UH Angers

  STUDY CHAIR

• Andréa PENALOZA, MD-PhD

  Clinique Universitaire Saint-Luc, Bruxelles

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2015
• First Posted: February 10, 2015
• Study Start: May 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 22, 2016

Record last verified: 2016-09

Locations

BE (3); FR (9)