改良诊断策略在急诊科安全排除肺栓塞的研究：非劣效性 MODIGLIANI 聚类交叉随机试验研究方案。
MOdified DIagnostic strateGy to safely ruLe-out pulmonary embolism In the emergency depArtment: study protocol for the Non-Inferiority MODIGLIANI cluster cross-over randomized trial.
机构信息
Emergency department, Hôpital Pitié-Salpêtrière, Assistance Publique - Hôpitaux de Paris, APHP, Sorbonne Université, Paris, France.
Emergency Department, Hospital Clinic, Barcelona, Spain.
出版信息
Trials. 2020 Jun 3;21(1):458. doi: 10.1186/s13063-020-04379-y.
INTRODUCTION
In the work-up strategy for pulmonary embolism (PE) in the ED, the recently introduced YEARS rule allows the raising of the D-dimer threshold to 1000 ng/ml in patients with no signs of deep venous thrombosis and no hemoptysis and in whom PE is not the most likely diagnosis. However, this decision rule has never been prospectively compared to the usual strategy. Furthermore, it is unclear if the YEARS rule can be used on top of the Pulmonary Embolism Rule-out Criteria (PERC). We aim to assess the non-inferiority of YEARS compared to current guidelines to rule out PE among PERC-positive ED patients with suspicion of PE.
METHODS/DESIGN: The MODIGLIANI study is a multicenter, European, non-inferiority, cluster-randomized, two periods cross-over, controlled trial. Each center will be randomized for the sequence of two 4-month periods: intervention (MOdified Diagnostic Strategy: MODS) followed by control (usual care), or control followed by intervention with 1 month of "wash-out" between the two periods. In the control period, the threshold will be as usual (500 ng/ml for patients aged 50 years or younger and age × 10 for older patients). In the MODS period, the threshold of D-dimers to rule out PE will be raised to 1000 ng/ml if no item of the YEARS score is present or will remain unchanged otherwise. Patients will be included if they have a suspicion of PE, defined as chest pain, dyspnea, or syncope. Non-inclusion criteria comprise a high clinical probability of PE or PERC-negative patients with low clinical probability.
ETHICS AND DISSEMINATION
The study has received the following approvals: Comité de protection des personnes Ile de France XI (France) and Comité de Ética de la Investigación con medicamentos del Hospital Clínic de Barcelona (Spain). Results will be made available to all included participants and other researchers.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT04032769. Registered on 24 July 2019.
简介
在急诊科（ED）进行肺栓塞（PE）的检查策略中，最近引入的 YEARS 规则允许在没有深静脉血栓形成迹象且无咯血且 PE 不太可能诊断的患者中，将 D-二聚体阈值提高至 1000ng/ml。然而，该决策规则从未前瞻性地与常规策略进行比较。此外，尚不清楚 YEARS 规则是否可用于 Pulmonary Embolism Rule-out Criteria（PERC）之上。我们旨在评估 YEARS 规则与目前的指南相比，在怀疑患有 PE 的 PERC 阳性 ED 患者中排除 PE 的非劣效性。
方法/设计：MODIGLIANI 研究是一项多中心、欧洲、非劣效性、聚类随机、两期交叉、对照试验。每个中心将随机分配两个为期 4 个月的时间段的顺序：干预期（改良诊断策略：MODS）后为对照组（常规护理），或对照组后为干预组，两者之间有 1 个月的“洗脱期”。在对照组中，阈值将如前所述（50 岁及以下患者为 500ng/ml，年龄较大的患者为年龄×10）。在 MODS 期间，如果 YEARS 评分没有一项存在，将提高 D-二聚体排除 PE 的阈值至 1000ng/ml，否则保持不变。如果患者有 PE 疑似症状，定义为胸痛、呼吸困难或晕厥，则将其纳入研究。排除标准包括 PE 临床高度可能或 PERC 阴性且临床低度可能的患者。
伦理和传播
该研究已获得以下批准：法兰西岛 XI 区保护委员会（法国）和巴塞罗那临床医院药物研究伦理委员会（西班牙）。结果将提供给所有纳入的参与者和其他研究人员。
试验注册
ClinicalTrials.gov，NCT04032769。于 2019 年 7 月 24 日注册。
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