Pulmonary EmbolismERASE PENCT04355975
Clinical Outcomes After Acute Pulmonary Embolism
An observational study of Pulmonary Embolism, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Embolism
- How many people
- 800 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 May 2020to 31 Dec 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: * Patients with Acute PE * Patients developing CTEPH
Who may be able to join
- Consecutive patients with pulmonary embolism matching the criteria for treatment according to the decision of the PERT.
- Written informed consent
Who cannot join
- High probability of non-adherence to the follow up requirements
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites, 2 recruiting
- Recruiting
University Hospital Bern - Inselspital
Bern, Canton of Bern, 3010
Stefan Stortecky, MD, 0041 31632 83 52, stefan.stortecky@insel.ch
- Recruiting
University Hospital Bern
Bern, 3010
Stefan Stortecky, MD, 0041316322111, stefan.stortecky@insel.ch
About this study
Official title: 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.
Read the 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.
- Conditions
- Pulmonary Embolism
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Medical Therapy / Anticoagulation | Not described | |
| Systemic Lysis | Not described | |
| Interventional Therapy for PE | Not described | |
| Surgical Embolectomy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital death
Measured: 30 days
Secondary outcomes (4)
Peri-procedural adverse events
Measured: 30 days
Recurrent VTE during follow-up
Measured: up to 5 years
Respiratory and functional deterioration after treatment
Measured: 6 months
Development of chronic thromboembolic pulmonary hypertension (CTEPH)
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start1 May 2020
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan Stortecky, MD, Principal investigator, Department of Cardiology, Bern University Hospital, University of Bern, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04355975
- Sponsor's protocol ID
- 4303 - 2019-02042
- Acronym
- ERASE PE
- Status last verified
- Dec 2022
- First submitted
- 17 Apr 2020
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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. Epub 2025 Apr 25.
PubMed 40281654
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes After Acute Pulmonary Embolism - The Bern Acute Pulmonary Embolism Registry
- ClinicalTrials.gov ID
- NCT04355975
- Acronym / sponsor ID
- ERASE PE / 4303 - 2019-02042
- Conditions
- Pulmonary Embolism
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 21 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Medical Therapy / Anticoagulation | – | – |
| Systemic Lysis | – | – |
| Interventional Therapy for PE | – | – |
| Surgical Embolectomy | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- * Patients with Acute PE * Patients developing CTEPH
Key inclusion criteria (2 listed)
- Consecutive patients with pulmonary embolism matching the criteria for treatment according to the decision of the PERT.
- Written informed consent
Key exclusion criteria (1 listed)
- High probability of non-adherence to the follow up requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
In-hospital death
Time frame: 30 days
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
- Derived from this study: PubMed 40281654Draxler 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. Epub 2025 Apr 25.
- Individual participant dataSharing planned: Undecided
Related trials for Pulmonary Embolism
RecruitingObservational study
Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System
Pulmonary Embolism
Not yet recruiting
Pilot Study Evaluating Catheter Directed Thrombolysis Device in Acute Intermediate Risk Pulmonary Embolism
Pulmonary Embolism (PE), Pulmonary Embolism With Right Ventricle Enlargement
RecruitingObservational study
Inari VISION Registry
Pulmonary Embolism
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stefan Stortecky, MD principal investigator
Department of Cardiology, Bern University Hospital, University of Bern, Switzerland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefan Stortecky, MD (+41 31 632 21 11, stefan.stortecky@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital death (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04355975, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2022.