Polish Multicenter Pulmonary Embolism Response Teams Outcomes Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Ventricular strain reduction
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 否
入选标准
- •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.
排除标准
- •Refusal to sign the informed consent form.
结局指标
主要结局
Ventricular strain reduction
时间窗: 24 hours after specific PE treatment implementation
Rate of right ventricular strain reduction (right ventricle/left ventricle ratio assessment) in echocardiography
Clinical improvement during hospitalization
时间窗: 24 hours after specific PE treatment implementation
Incidence of arterial blood saturation increase \>92%
Early mortality rate from pulmonary embolism
时间窗: Two weeks since PE diagnosis
Number of patients who died from pulmonary embolism (right heart failure)
次要结局
- Total mortality rate from pulmonary embolism(3 months since PE diagnosis)
- Bleeding events incidence(3 months since PE diagnosis)
研究者
Aleksander Araszkiewicz
Professor of Medicine
Poznan University of Medical Sciences
