PERCEPIC: PERC Rule Combined With Implicit Low Clinical Probability

• Register: ClinicalTrials.gov
• Last refreshed on: 3 October 2016
• Main ID: NCT02360540
• Date of registration: 05/02/2015
• Prospective Registration: Yes
• Primary sponsor: University Hospital, Angers
• Public title: PERCEPIC: PERC Rule Combined With Implicit Low Clinical Probability PERCEPIC
• Scientific 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
• Date of first enrolment: May 2015
• Target sample size: 1773
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02360540
• Study type: Observational [Patient Registry]
• Study design: Observational Model: Cohort, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

Belgium, France

Contacts

• Name: Andréa PENALOZA, MD-PhD
• Affiliation: Clinique Universitaire Saint-Luc, Bruxelles

• Name: Pierre-Marie ROY, MD-PhD
• Affiliation: UH Angers

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Pulmonary Embolism

Thoracic Pain

Dyspnea

Intervention(s)

Other: Gestalt estimation

Primary Outcome(s)

To assess the accuracy of the combination of low implicit clinical probability (gestalt) and negative PERC rule (8 criteria absents) [Time Frame: 3 months]

Secondary Outcome(s)

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]

To assess usefulness of PERC and implicit low clinical probability combination to reduce the use of further exams [Time Frame: During emergency managment]

To compare performances of clinical probability assessment methods : implicit assessment, revised Geneva Score, Wells Score and implicit overridden Geneva Score [Time Frame: 3 months]

Secondary ID(s)

PHRC2014_02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Cliniques universitaires Saint-Luc- Université Catholique de Louvain