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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02360540
Other study ID # PHRC2014_02
Secondary ID
Status Completed
Phase N/A
First received February 5, 2015
Last updated September 21, 2016
Start date May 2015
Est. completion date July 2016

Study information

Verified date September 2016
Source University Hospital, Angers
Contact n/a
Is FDA regulated No
Health authority France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: Commission nationale de l'informatique et des libertés
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1773
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
Gestalt estimation


Locations

Country Name City State
Belgium Clinique Universitaire Saint-Luc Bruxelles
Belgium UH Erasme Bruxelles
Belgium UH Liège Liège
France Hospital of Agen Agen
France UH Angers Angers
France Hospital of Argenteuil Argenteuil
France UH Clermont-Ferrand Clermont-Ferrand
France Hospital of Le Mans Le Mans
France UH Nantes Nantes
France UH Poitiers Poitiers
France UH Rennes Rennes
France Hospital of Saint-Brieuc Saint-Brieuc

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Angers Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type Measure Description Time frame Safety issue
Primary To assess the accuracy of the combination of low implicit clinical probability (gestalt) and negative PERC rule (8 criteria absents) 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 Yes
Secondary To assess usefulness of PERC and implicit low clinical probability combination to reduce the use of further exams Mean number of further exams performed per diagnostic strategy During emergency managment No
Secondary 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) For each methods, AUC in receiver operating characteristic analyses of the 3-level classification scheme will be compared. 3 months No
Secondary To compare performances of clinical probability assessment methods : implicit assessment, revised Geneva Score, Wells Score and implicit overridden Geneva Score For each methods, AUC in receiver operating characteristic analyses of the 3-level classification scheme will be compared 3 months No
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