The Pulmonary Embolism Rule Out Criteria (PERC) Rule to Exclude the Diagnosis of Pulmonary Embolism in Emergency Low Risk Patients: a Non-inferiority Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,922
- 试验地点
- 1
- 主要终点
- Failure percentage of the diagnostic strategy (diagnosed deep venous thrombosis or pulmonary embolism) at 3 month follow up
研究概览
简要总结
The Pulmonary Embolism Rule Out Criteria (PERC) is an 8-item rule, that was derived and tested to rule out the diagnosis of Pulmonary Embolism (PE) in the Emergency Department (ED) amongst low risk patients. Even though meta analyses have confirmed the safety of its utilization, equipoise remains - especially in European country where the prevalence of PE is higher than in the US- on whether this rule could be safely applied to all low risk emergency patients with a suspicion of PE.
The PROPER Trial is a non inferiority , cluster randomized trial. All centers will recruit patients with a suspicion of PE and a low pre test probability. To rule out the diagnosis of PE, center will use the usual diagnostic strategies with D-dimeres measurement for 6 months, and PERC based strategy for 6 months.
In the control group (usual strategy), patients will be tested for D-dimeres, followed if positive by a Computed Tomography of Pulmonary Artery (CTPA).
In the intervention group (PERC Based), patients will be first assessed with PERC score. If PERC=0, then the diagnosis of PE will be exclude with no supplemental investigations. If PERC>0, then patients will undergo the usual strategy, with D-dimeres measurement +/- CTPA.
The primary outcome is the failure percentage of the diagnostic strategy, defined as diagnosed deep venous thrombosis (DVT) or PE at 3 month follow up, among patients for whom PE has been initially ruled out.
详细描述
The diagnosis of Pulmonary Embolism (PE) in the Emergency Department (ED) is crucial. As emergency physicians fear to miss this potential lethal condition, PE tends to be overdiagnosed with potential source of unnecessary risks and no clear benefit in terms of outcome. PERC is an 8-item block of clinical criteria that can identify patients who can safely be discharged without further investigation in the ED for the diagnosis of PE. The endorsement of this rule could markedly reduce the number of irradiative imaging studies, length of stay in the ED, and rate of adverse event resulting from both diagnostic and therapeutic means. Several retrospective and prospective studies have shown the safety and benefits of PERC rule for PE diagnosis in low risk patients. However, no randomized study has yet compared the benefit/risk ratio of PERC based strategy with the standard diagnosis strategy and thus validated its endorsement in this setting. We hypothesize that in patients with a low gestalt clinical probability and a PERC negative, PE can be safely ruled out and the patient discharged with no further testing
This is a controlled, cluster randomized trial in Europe (N=15). Each center will be randomized on the sequence of period intervention: 6 months intervention (PERC based strategy) followed by 6 months control (usual care), or 6 months control followed by 6 months intervention with 2 months of "wash-out" between the two periods.
The primary objective of this study is to assess the non inferiority of a PERC based diagnosis strategy for PE low risk emergency patients, compared to the standard strategy of D-dimer testing, on the occurrence of non-diagnosed thrombo-embolic event.
The primary outcome is the failure percentage of the diagnostic strategy, defined as diagnosed DVT or PE at 3 month follow up, among patients for whom PE has been initially ruled out. Exclusion of PE in the ED is made upon negative D-dimere result or negative CTPA in both groups, or negative PERC in the intervention group.
Secondary objectives are :
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Acute onset of, or worsening of dyspnea Or chest pain
- •Low clinical pretest probability of PE, empiricially estimated by the gestalt.
排除标准
- •Other obvious cause than PE for dyspnea or chest pain
- •Acute severe presentation
- •Contra-indication to CTPA
- •Concurrent anticoagulation treatment
- •Current diagnosed thrombo-embolic event
- •Inability to follow up
- •Prisoners
- •Pregnancy
- •No social security
- •Participation in another intervention trial
研究组 & 干预措施
Control
Emergency physician will assess low risk patients for PE with conventional strategy, using D-Dimer testing with subsequent CTPA if positive
Intervention
PERC based Strategy : Emergency physician will assess low risk patients for PE first with calculation of PERC score. If all PERC criteria are negative, then no further testing for PE is recommended. If at least one criterion is positive, then the patient undergoes D-Dimer testing with subsequent CTPA if positive
干预措施: PERC based Strategy (Other)
结局指标
主要结局
Failure percentage of the diagnostic strategy (diagnosed deep venous thrombosis or pulmonary embolism) at 3 month follow up
时间窗: 3 months
次要结局
- Rate of Computed Tomography Pulmonary Angiogram (CTPA) and related adverse event(3 months)
- Length of stay in the Emergency Department(From date of entry in the emergency department to date of exit)
- Anticoagulation therapy administration (number of day with treatment within three months)(3 months)
- Rate of patients admitted in the hospital following Emergency Department visit(3 months)
- All causes re hospitalization at 3 months(3 months)
- Death from all causes at 3 months(3 months)