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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,773
- 试验地点
- 12
- 主要终点
- To assess the accuracy of the combination of low implicit clinical probability (gestalt) and negative PERC rule (8 criteria absents)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
To assess the accuracy of the combination of low implicit clinical probability (gestalt) and negative PERC rule (8 criteria absents)
时间窗: 3 months
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
次要结局
- To assess usefulness of PERC and implicit low clinical probability combination to reduce the use of further exams(During emergency managment)
- 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)(3 months)
- To compare performances of clinical probability assessment methods : implicit assessment, revised Geneva Score, Wells Score and implicit overridden Geneva Score(3 months)