ERASE PE: Clinical Outcomes After Acute Pulmonary Embolism

Sponsor

University Hospital Inselspital, Berne (Other)

Overall Status

Recruiting

CT.gov ID

NCT04355975

Collaborator

(none)

800

Enrollment

Locations

128

Anticipated Duration (Months)

400

Patients Per Site

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Embolism

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 [Patient Registry]

Anticipated Enrollment :

800 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 1, 2020

Anticipated Primary Completion Date :

Dec 31, 2030

Anticipated Study Completion Date :

Dec 31, 2030

Arms and Interventions

Arm	Intervention/Treatment
Medical Therapy / Anticoagulation
Systemic Lysis
Interventional Therapy for PE
Surgical Embolectomy

Outcome Measures

Primary Outcome Measures

In-hospital death [30 days]

Secondary Outcome Measures

Peri-procedural adverse events [30 days]
Recurrent VTE during follow-up [up to 5 years]
Respiratory and functional deterioration after treatment [6 months]
Development of chronic thromboembolic pulmonary hypertension (CTEPH) [up to 5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Bern - Inselspital	Bern	BE	Switzerland	3010
2	University Hospital Bern	Bern		Switzerland	3010

Sponsors and Collaborators

University Hospital Inselspital, Berne

Investigators

Principal Investigator: Stefan Stortecky, MD, Department of Cardiology, Bern University Hospital, University of Bern, Switzerland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital Inselspital, Berne

ClinicalTrials.gov Identifier:

NCT04355975

Other Study ID Numbers:

4303 - 2019-02042

First Posted:

Apr 21, 2020

Last Update Posted:

Jun 9, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Pulmonary Embolism

Embolism

Study Results

No Results Posted as of Jun 9, 2021