Pulmonary Embolism Clinical Trial
Official 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
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.
n/a
Observational Model: Cohort, Time Perspective: Prospective
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