MOdified DIagnostic strateGy to Safely ruLe-out Pulmonary Embolism In the Emergency depArtment: A Non-Inferiority Cluster Cross-over Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,414
- 试验地点
- 2
- 主要终点
- the failure percentage of the diagnostic strategy, defined as a diagnosed thrombo-embolic event at 3 month follow-up
研究概览
简要总结
Because a missed PE could be potentially lethal, several researches reported that PE is both overinvestigated and overdiagnosed. The diagnostic gold standard for PE is the computed tomographic pulmonary angiogram (CTPA) and has been shown to have clear risks and other downsides. To limit the use of CTPA, two rules were recently reported to be safe to exclude PE: the PERC rule and the YEARS rule. PERC is an 8 item block of clinical criteria that has recently been validated to safely exclude PE in low risk patients. YEARS is a clinical rule that allow to raise the threshold of D-dimer for the order of CTPA. However, whether a modified diagnostic algorithm that includes these two rules combined could safely reduce imaging study use in the ED is unknown.
This is a non-inferiority, cluster cross-over randomized, international trial.
Each center will be randomized on the sequence of period intervention: 4 months intervention (MOdified Diagnostic Strategy: MODS) followed by 4 months control (usual care), or 4 months control followed by 4 months intervention with 1 month of "wash-out" between the two periods.
All centers will recruit adult emergency patients with a suspicion of PE.
In the control group (usual strategy), patients will be tested for D-dimer, followed if positive by a CTPA.
In the intervention group (MODS) :
All included patients will be tested with quantitative D-dimer. The MODS work-up will be based on YEARS rule :
- If all YEARS criteria are absent, the threshold of D-Dimer for ordering a CTPA will be raised.
If at least one criterion of YEARS is present, then the D-dimer threshold for ordering a CTPA will be as usual.
详细描述
The diagnosis of Pulmonary Embolism (PE) is a crucial matter in the Emergency Department (ED). Because a missed PE could be potentially lethal, several researches reported that PE is both overinvestigated and overdiagnosed. The diagnostic gold standard for PE is the computed tomographic pulmonary angiogram (CTPA) and has been shown to have clear risks (allergic reaction, acute renal failure, delayed solid tumor) and other downsides such as prolonged ED stay and increased cost. To limit the use of CTPA, two rules were recently reported to be safe to exclude PE: the PERC rule and the YEARS rule.
PERC is an 8 item block of clinical criteria that has recently been validated to safely exclude PE in low risk patients.
YEARS is a clinical rule that allow to raise the threshold of D-dimer for the order of CTPA. However, whether a modified diagnostic algorithm that includes these two rules combined could safely reduce imaging study use in the ED is unknown.
The primary objective of this trial is to assess the safety of a modified diagnostic strategy (MODS) with the YEARS for patients in whom PE was not excluded by PERC score in the ED.
The primary endpoint is the failure percentage of the diagnostic strategy, defined as a diagnosed thrombo-embolic event at 3 month follow-up (either a PE or a deep venous thrombosis), among patients in whom PE has been initially ruled out.
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
- •Patient aged ≥ 18 years that presents to an ED
- •With new onset of or worsening of shortness of breath or chest pain or syncope
排除标准
- •Opposition to the participation to the study
- •Anticipated inability to follow up at 3 month
- •Other obvious cause than PE for chest pain, syncope or dyspnea
- •High clinical probability of PE (estimated by the physician gestalt as > 50%) or low clinical probability and PERC negative patients
- •Low clinical probability (estimated by the physician gestalt as < 15%) and no item of the PERC score (heart rate > 100, Sa02 < 95, unilateral leg swelling, hemoptysis, past history of thrombo-embolism, exogen estrogen intake, recent trauma or surgery, age ≥ 50)
- •Acute severe presentation (clinical signs of respiratory distress, hypotension, SpO2<90%, shock)
- •Concurrent anticoagulation treatment
- •Current diagnosed thrombo-embolic event (in the past 6 months)
- •Prisoners
- •Pregnancy
- •No social security
- •Participation in another intervention trial
研究组 & 干预措施
Modified strategy MODS
the threshold of D-dimer will depend on the YEARS rule (MODS strategy):
- If all the three items of YEARS are negative (i.e. No hemoptysis, No clinical sign of deep venous thrombosis and PE is not the most likely diagnosis), then the threshold of D-dimer will be raised at 1000 ng/ml.
- If at least one item of YEARS is positive, then the threshold will remain unchanged (">500 ng/ml" for patients aged < 50 and "> agex10" for patients aged 50 and over).
- A positive result of D-dimer and the absence of other obvious cause for PE will mandate a CTPA, or V/Q scan if CTPA is contra-indicated.
- A negative result of D-dimer will rule out PE.
干预措施: MODS (MOdified Diagnostic Strategy) (Other)
Control group
All included patients will be tested with D-Dimer, threshold for ordering a CTPA as usual
结局指标
主要结局
the failure percentage of the diagnostic strategy, defined as a diagnosed thrombo-embolic event at 3 month follow-up
时间窗: 3 months follow up
existence of a diagnosed thrombo embolic event (PE or DVT) among patients in whom PE has been initially ruled out.
次要结局
- reduced irradiative imaging studies(3 months follow up)
- hospital re admission(3 months)
- mortality(3 months)
- hospital admission(3 months follow up)
- total cost and cost effectiveness(3 months)
- ED length of stay(Through ED Discharge within 24 hours)
- Safety of the PEPS score(3 months)
- anticoagulant therapy administration(3 months follow up)