Clinical Outcomes After Acute Pulmonary Embolism - The Bern Acute Pulmonary Embolism Registry
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 800
- Locations
- 2
- Primary Endpoint
- In-hospital death
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Consecutive patients with pulmonary embolism matching the criteria for treatment according to the decision of the PERT.
- •Written informed consent
Exclusion Criteria
- •High probability of non-adherence to the follow up requirements
Outcomes
Primary Outcomes
In-hospital death
Time Frame: 30 days
Secondary Outcomes
- 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)