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NCT Number: NCT04355975

Clinical Outcomes After Acute Pulmonary Embolism

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.

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Key information

Conditions

Pulmonary Embolism Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Respiratory Tract Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Bern - Inselspital, Bern, Canton of Bern, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. In-hospital death

    Time frame: 30 days

Secondary outcomes

  1. Peri-procedural adverse events

    Time frame: 30 days

  2. Recurrent VTE during follow-up

    Time frame: up to 5 years

  3. Respiratory and functional deterioration after treatment

    Time frame: 6 months

  4. Development of chronic thromboembolic pulmonary hypertension (CTEPH)

    Time frame: up to 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Stefan Stortecky, MD

CONTACT

[email protected]

+41 31 632 21 11

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

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

Acronym: ERASE PE

Important dates

Study start
2020
Primary completion
2030
Study completion
2030
First posted
Apr 21, 2020
Registry last updated
Dec 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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