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Polish Multicenter PERTs PE Outcomes Registry (PolPERTs)

2021年5月4日 更新者:Aleksander Araszkiewicz、Poznan University of Medical Sciences

Polish Multicenter Pulmonary Embolism Response Teams Outcomes Registry

Pulmonary embolism (PE) is the third leading cause of cardiovascular mortality. The Pulmonary Embolism Response Team (PERT) concept offers a rapid and multidisciplinary approach focused on improving outcomes for patients with PE. All institutionalized PERTs in Poland have been invited to join the study. The goal of this registry is to describe current practice and outcomes in patients with acute PE treated by Polish PERTs.

研究概览

地位

招聘中

详细说明

Pulmonary embolism (PE) is the third leading cause of cardiovascular mortality. The presentation of PE may vary from asymptomatic or mild exertion disturbances (low-risk PE) treated with anticoagulants only to hemodynamic "obstructive" collapse and death (high-risk PE). Patient outcome depends on ability of the right ventricle to sustain the increased afterload caused by the embolic burden. Careful risk stratification is crucial, and the Pulmonary Embolism Response Team (PERT) concept offers a rapid and multidisciplinary approach focused on improving outcomes for patients with PE by advancing its recognition, diagnosis, and treatment. All institutionalized PERTs in Poland have been invited to join the study. The data is administrated by the Poznan University of Medical Sciences on the basis of an agreement between the PERT centres.

The goal of this registry is to describe current practice and outcomes in patients with acute PE guided by Polish PERTs. The primary data recorded include details of each patient's clinical status, co-morbidities, the administered treatment modalities, the results of additional studies (ab tests results, ECG, imaging studies), and the outcome.

The data collection will have no impact on the way the patient is diagnosed and treated.The study endpoints comprise respiratory failure, shock, death distal systemic embolization (i.e. stroke) and major or minor bleeding complications classified according to the International Society on Thrombosis and Haemostasis classification.

研究类型

观察性的

注册 (预期的)

10000

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

    • GreaterPoland
      • Poznań、GreaterPoland、波兰、61-848

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Consecutive patients hospitalized due to high-risk or intermediate-high risk PE.

描述

Inclusion Criteria:

  1. PE confirmed by computed tomography pulmonary angiography.
  2. PE symptoms duration ≤ 14 days.
  3. High-risk PE with hemodynamic instability (one of):

    • cardiac arrest
    • obstructive shock
    • persistent hypotension.
  4. Intermediate-high risk PE patients with right ventricle dysfunction confirmed by imaging studies and elevated troponin level.

Exclusion Criteria:

1. Refusal to sign the informed consent form.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
Intermediate-high risk PE
Confirmed PE causing right ventricle dysfunction confirmed by computed tomography pulmonary angiography or transthoracic echocardiography and elevated troponin level
High-risk PE

Confirmed PE causing hemodynamic instability:

  1. Cardiac arrest (need for cardiopulmonary resuscitation) or,
  2. Obstructive shock (systolic blood pressure < 90 mmHg or vasopressors required to achieve a systolic blood pressure ≥90 mmHg despite adequate filling status and end-organ hypoperfusion), or
  3. Persistent hypotension (systolic blood pressure < 90 mmHg for at least 15 minutes)

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Clinical improvement during hospitalization
大体时间:24 hours after specific PE treatment implementation
Incidence of arterial blood saturation increase >92%
24 hours after specific PE treatment implementation
Ventricular strain reduction
大体时间:24 hours after specific PE treatment implementation
Rate of right ventricular strain reduction (right ventricle/left ventricle ratio assessment) in echocardiography
24 hours after specific PE treatment implementation
Early mortality rate from pulmonary embolism
大体时间:Two weeks since PE diagnosis
Number of patients who died from pulmonary embolism (right heart failure)
Two weeks since PE diagnosis

次要结果测量

结果测量
措施说明
大体时间
Total mortality rate from pulmonary embolism
大体时间:3 months since PE diagnosis
Number of patients who died from pulmonary embolism (right heart failure)
3 months since PE diagnosis
Bleeding events incidence
大体时间:3 months since PE diagnosis
Incidence of major bleedings assessed using ISTH criteria
3 months since PE diagnosis

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Aleksander Araszkiewicz, Prof.、Poznan University of Medical Sciences

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年6月1日

初级完成 (预期的)

2023年6月1日

研究完成 (预期的)

2030年12月1日

研究注册日期

首次提交

2021年5月4日

首先提交符合 QC 标准的

2021年5月4日

首次发布 (实际的)

2021年5月10日

研究记录更新

最后更新发布 (实际的)

2021年5月10日

上次提交的符合 QC 标准的更新

2021年5月4日

最后验证

2021年5月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

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研究美国 FDA 监管的设备产品

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