Clinical Outcomes After Acute Pulmonary Embolism

Recruiting

• Conditions: Pulmonary Embolism

• Registration Number: NCT04355975
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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 Timeline

• Study First Submitted: 2020-04-17
• Study First Submitted QC: 2020-04-17
• Study First Posted: 2020-04-21
• Study Start: 2020-05-01
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-14
• Last Update Posted: 2022-12-15
• Primary Completion: 2030-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
In-hospital death	30 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

University Hospital Bern - Inselspital; 🇨🇭 Bern, BE, Switzerland

University Hospital Bern; 🇨🇭 Bern, Switzerland