NCT02360540

PERCEPIC: PERC Rule Combined With Implicit Low Clinical Probability

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,773 (actual)
• Sponsor: University Hospital, Angers · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	Gestalt estimation

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2015-02-10
• Last updated: 2016-09-22

Locations

12 sites across 2 countries: Belgium, France