Clinical Outcomes After Acute Pulmonary Embolism

Pulmonary Embolism Clinical Trial

— ERASE PE  

Official title:

Clinical Outcomes After Acute Pulmonary Embolism - The Bern Acute Pulmonary Embolism Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04355975
• Other study ID #: 4303 - 2019-02042
• Status: Recruiting
• Start date: May 1, 2020
• Est. completion date: December 31, 2030

Study information

• Verified date: December 2022
• Source: University Hospital Inselspital, Berne
• Contact: Stefan Stortecky, MD
• Phone: +41 31 632 21 11
• Email: stefan.stortecky[@]insel.ch
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Locations

Country	Name	City	State
Switzerland	University Hospital Bern	Bern
Switzerland	University Hospital Bern - Inselspital	Bern	BE

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-hospital death		30 days
Secondary	Peri-procedural adverse events		30 days
Secondary	Recurrent VTE during follow-up		up to 5 years
Secondary	Respiratory and functional deterioration after treatment		6 months
Secondary	Development of chronic thromboembolic pulmonary hypertension (CTEPH)		up to 5 years