Clinical Outcomes After Acute Pulmonary Embolism (ERASE PE)

December 14, 2022 updated by: University Hospital Inselspital, Berne

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

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Recruiting
        • University Hospital Bern
        • Contact:
    • BE
      • Bern, BE, Switzerland, 3010
        • Recruiting
        • University Hospital Bern - Inselspital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  • Patients with Acute PE
  • Patients developing CTEPH

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Medical Therapy / Anticoagulation
Systemic Lysis
Interventional Therapy for PE
Surgical Embolectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
In-hospital death
Time Frame: 30 days
30 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2020

Primary Completion (Anticipated)

December 31, 2030

Study Completion (Anticipated)

December 31, 2030

Study Registration Dates

First Submitted

April 17, 2020

First Submitted That Met QC Criteria

April 17, 2020

First Posted (Actual)

April 21, 2020

Study Record Updates

Last Update Posted (Actual)

December 15, 2022

Last Update Submitted That Met QC Criteria

December 14, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4303 - 2019-02042

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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