Clinical Outcomes After Acute Pulmonary Embolism

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04355975

Acronym

ERASE PE

Enrollment

800

Registered

2020-04-21

Start date

2020-05-01

Completion date

2030-12-31

Last updated

2022-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Embolism

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame
In-hospital death	30 days

Secondary

Measure	Time frame
Respiratory and functional deterioration after treatment	6 months
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

Countries

Switzerland

Contacts

Primary ContactStefan Stortecky, MD

stefan.stortecky@insel.ch+41 31 632 21 11

Outcome results