Polish Multicenter PERTs PE Outcomes Registry (PolPERTs)
Polish Multicenter Pulmonary Embolism Response Teams Outcomes Registry
研究概览
地位
条件
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
注册 (预期的)
联系人和位置
学习联系方式
- 姓名:Aleksander Araszkiewicz
- 电话号码:+48 8549146
- 邮箱:aaraszkiewicz@ump.edu.pl
研究联系人备份
- 姓名:Sylwia Sławek-Szmyt
- 电话号码:+48 8549293
- 邮箱:sylwia.slawek@skpp.edu.pl
学习地点
-
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GreaterPoland
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Poznań、GreaterPoland、波兰、61-848
- 招聘中
- Poznan University of Medical Sciences
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接触:
- Aleksander Araszkiewicz, Prof.
- 电话号码:+48 8549149
- 邮箱:aaraszkiewicz@ump.edu.pl
-
接触:
- Sylwia Sławek-Szmyt, MD, PhD
- 邮箱:sylwia.slawek@skpp.edu.pl
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- PE confirmed by computed tomography pulmonary angiography.
- PE symptoms duration ≤ 14 days.
High-risk PE with hemodynamic instability (one of):
- cardiac arrest
- obstructive shock
- persistent hypotension.
- 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
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:
|
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
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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
调查人员
- 首席研究员:Aleksander Araszkiewicz, Prof.、Poznan University of Medical Sciences
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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