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临床试验/NCT06067997
NCT06067997已完成不适用

Prevalence Of Pulmonary Embolism In Patients With HEmoptysis (POPEIHE)

Società Italiana di Medicina di Emergenza-Urgenza1 个研究点 分布在 1 个国家目标入组 550 人开始时间: 2019年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
550
试验地点
1
主要终点
incidence of pulmonary embolism

研究概览

简要总结

Estimation of the incidence of pulmonary embolism in patients presenting to the Emergency Department with hemoptysis.

详细描述

Multicenter prospective observational cross-sectional study with non-commercial (non-profit) objectives.

The study population consists of consecutive patients who present to the Emergency Departments of the participating hospitals with hemoptysis.

The diagnosis of pulmonary embolism will be made using the diagnostic algorithm suggested by the 2019 European guidelines. The pre-test clinical probability of pulmonary embolism will be defined based on the simplified Wells score, which classifies pulmonary embolism as "likely" or "unlikely". In patients with a low pre-test clinical probability ("unlikely") and a D-dimer level below the threshold value (negative), the diagnosis of pulmonary embolism will be excluded, and further testing will not be necessary in this regard. The D-dimer level will be measured using the quantitative assay routinely used in each participating center; the threshold value for a positive result compared to a negative result is 500 μg per milliliter for patients under 50 years of age. For each additional decade of age, the exclusion cutoff will increase by 100 μg per milliliter.

For patients with a high pre-test clinical probability ("likely"), a positive D-dimer test, or both, a pulmonary CT angiography will be the diagnostic test of choice.

The criterion for the presence of pulmonary embolism is the detection of an intraluminal filling defect on CT.

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

入选标准

  • Consecutive patients who present to the Emergency Department of the participating centers with hemoptysis
  • consent to participate.

排除标准

  • Pregnancy.
  • Age below 18 years.
  • Terminal illnesses with an estimated prognosis of less than 3 months.

结局指标

主要结局

incidence of pulmonary embolism

时间窗: 30 days within initial evaluation

The incidence of pulmonary embolism in patients presenting to the Emergency Department with hemoptysis/haemoptysis.

次要结局

未报告次要终点

研究者

发起方
Società Italiana di Medicina di Emergenza-Urgenza
申办方类型
Other
责任方
Sponsor

研究点 (1)

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