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Recruiting NCT04355975

Clinical Outcomes After Acute Pulmonary Embolism

Observational Pulmonary Embolism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Pulmonary Embolism. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • In-hospital death [Time frame: 30 days]
Secondary outcome measures (4)
  • Peri-procedural adverse events [Time frame: 30 days]
  • Recurrent VTE during follow-up [Time frame: up to 5 years]
  • Respiratory and functional deterioration after treatment [Time frame: 6 months]
  • Development of chronic thromboembolic pulmonary hypertension (CTEPH) [Time frame: up to 5 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Switzerland · 2 centers
  • University Hospital Bern - Inselspital — Bern
  • University Hospital Bern — Bern

Publications

  • Draxler DF, Johannes JK, Nakase M, Heg D, Dobner S, Turovskij E, Furholz M, Haner J, Lanz J, Pilgrim T, Hunziker L, Praz F, Raber L, Rohla M, Siontis GCM, Susuri-Pfammatter N, Windecker S, Stortecky S. Clinical Outcomes in Patients With Acute Pulmonary Embolism Undergoing Ultrasound-Assisted Catheter-Directed Thrombolysis. J Am Heart Assoc. 2025 May 6;14(9):e035916. doi: 10.1161/JAHA.124.035916. E PMID 40281654

Identifiers

NCT: NCT04355975 · 4303 - 2019-02042

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗