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

September 21, 2016 updated by: University Hospital, Angers

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1773

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium
        • Clinique Universitaire Saint-Luc
      • Bruxelles, Belgium
        • UH Erasme
      • Liège, Belgium
        • UH Liège
  • France
      • Agen, France
        • Hospital of Agen
      • Angers, France
        • Uh Angers
      • Argenteuil, France
        • Hospital of Argenteuil
      • Clermont-Ferrand, France
        • UH Clermont-Ferrand
      • Le Mans, France
        • Hospital of Le Mans
      • Nantes, France
        • Uh Nantes
      • Poitiers, France
        • UH Poitiers
      • Rennes, France
        • UH Rennes
      • Saint-Brieuc, France
        • Hospital of Saint-Brieuc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
Time Frame: 3 months
For each methods, AUC in receiver operating characteristic analyses of the 3-level classification scheme will be compared.
3 months
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

February 5, 2015

First Submitted That Met QC Criteria

February 9, 2015

First Posted (Estimate)

February 10, 2015

Study Record Updates

Last Update Posted (Estimate)

September 22, 2016

Last Update Submitted That Met QC Criteria

September 21, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHRC2014_02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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