- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04355975
Clinical Outcomes After Acute Pulmonary Embolism (ERASE PE)
Clinical Outcomes After Acute Pulmonary Embolism - The Bern Acute Pulmonary Embolism Registry
Study Overview
Status
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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Stefan Stortecky, MD
- Phone Number: +41 31 632 21 11
- Email: stefan.stortecky@insel.ch
Study Locations
-
-
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Bern, Switzerland, 3010
- Recruiting
- University Hospital Bern
-
Contact:
- Stefan Stortecky, MD
- Phone Number: 0041316322111
- Email: stefan.stortecky@insel.ch
-
-
BE
-
Bern, BE, Switzerland, 3010
- Recruiting
- University Hospital Bern - Inselspital
-
Contact:
- Stefan Stortecky, MD
- Phone Number: 0041 31632 83 52
- Email: stefan.stortecky@insel.ch
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
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
Investigators
- Principal Investigator: Stefan Stortecky, MD, Department of Cardiology, Bern University Hospital, University of Bern, Switzerland
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
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.
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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