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NCT Number: NCT02360540

PERCEPIC: PERC Rule Combined With Implicit Low Clinical Probability

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.

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Key information

Conditions

Pulmonary Embolism Cardiovascular Diseases Chest Pain Dyspnea Embolism Embolism and Thrombosis Lung Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Thoracic Pain Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique Universitaire Saint-Luc, Brussels, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gestalt estimation

Other

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Collaborators

  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Registry information

Official study 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

Acronym: PERCEPIC

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 10, 2015
Registry last updated
Sep 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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