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PERCEPIC: PERC Rule Combined With Implicit Low Clinical Probability

NCT02360540 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1773

Last updated 2016-09-22

No results posted yet for this study

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

Interventions

OTHER

Gestalt estimation

Sponsors & Collaborators

  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    collaborator OTHER

  • University Hospital, Angers

    lead OTHER_GOV

Principal Investigators

  • Pierre-Marie ROY, MD-PhD · UH Angers

  • Andréa PENALOZA, MD-PhD · Clinique Universitaire Saint-Luc, Bruxelles

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • Belgium
  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02360540 on ClinicalTrials.gov