Clinical Outcomes After Acute Pulmonary Embolism - The Bern Acute Pulmonary Embolism Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 2
- 主要终点
- In-hospital death
研究概览
简要总结
To investigate safety and effectiveness of PE treatment according to the decision of the multi-disciplinary pulmonary embolism response team (PERT) and to define and optimize treatment indications, institutional algorithms and interventional techniques for PE.
详细描述
This single-center cohort study is designed to retrospectively and prospectively collect treatment and outcome data related to patients with PE and after activation of the PERT. Treatment information and outcomes after advanced treatment modalities, including systemic thrombolysis, catheter directed thrombolysis and surgical embolectomy, will be collected.
Retrospective patient data will consist of treatment and health related outcomes of consecutive patients treated for acute and chronic PE between October 2017 and April 2020 (to assess the learning curve of the PERT) and of patients receiving surgical embolectomy between January 2001 and April 2020. The retrospective data will be derived from the local institutional dataset and will be transferred to the study database. Prospective patients will be included after May 2020.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive patients with pulmonary embolism matching the criteria for treatment according to the decision of the PERT.
- •Written informed consent
排除标准
- •High probability of non-adherence to the follow up requirements
结局指标
主要结局
In-hospital death
时间窗: 30 days
次要结局
- Development of chronic thromboembolic pulmonary hypertension (CTEPH)(up to 5 years)
- Peri-procedural adverse events(30 days)
- Recurrent VTE during follow-up(up to 5 years)
- Respiratory and functional deterioration after treatment(6 months)