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Polish Multicenter PERTs PE Outcomes Registry

Polish Multicenter Pulmonary Embolism Response Teams Outcomes Registry

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04879069
Acronym
PolPERTs
Enrollment
10000
Registered
2021-05-10
Start date
2018-06-01
Completion date
2030-12-31
Last updated
2021-05-10

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

Conditions

Pulmonary Embolism With Acute Cor Pulmonale

Keywords

pulmonary embolism, pulmonary embolism response team,

Brief summary

Pulmonary embolism (PE) is the third leading cause of cardiovascular mortality. The Pulmonary Embolism Response Team (PERT) concept offers a rapid and multidisciplinary approach focused on improving outcomes for patients with PE. All institutionalized PERTs in Poland have been invited to join the study. The goal of this registry is to describe current practice and outcomes in patients with acute PE treated by Polish PERTs.

Detailed description

Pulmonary embolism (PE) is the third leading cause of cardiovascular mortality. The presentation of PE may vary from asymptomatic or mild exertion disturbances (low-risk PE) treated with anticoagulants only to hemodynamic obstructive collapse and death (high-risk PE). Patient outcome depends on ability of the right ventricle to sustain the increased afterload caused by the embolic burden. Careful risk stratification is crucial, and the Pulmonary Embolism Response Team (PERT) concept offers a rapid and multidisciplinary approach focused on improving outcomes for patients with PE by advancing its recognition, diagnosis, and treatment. All institutionalized PERTs in Poland have been invited to join the study. The data is administrated by the Poznan University of Medical Sciences on the basis of an agreement between the PERT centres. The goal of this registry is to describe current practice and outcomes in patients with acute PE guided by Polish PERTs. The primary data recorded include details of each patient's clinical status, co-morbidities, the administered treatment modalities, the results of additional studies (ab tests results, ECG, imaging studies), and the outcome. The data collection will have no impact on the way the patient is diagnosed and treated.The study endpoints comprise respiratory failure, shock, death distal systemic embolization (i.e. stroke) and major or minor bleeding complications classified according to the International Society on Thrombosis and Haemostasis classification.

Interventions

None listed

Sponsors

Polish Cardiac Society
CollaboratorOTHER
Poznan University of Medical Sciences
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. PE confirmed by computed tomography pulmonary angiography. 2. PE symptoms duration ≤ 14 days. 3. High-risk PE with hemodynamic instability (one of): * cardiac arrest * obstructive shock * persistent hypotension. 4. Intermediate-high risk PE patients with right ventricle dysfunction confirmed by imaging studies and elevated troponin level.

Exclusion criteria

1\. Refusal to sign the informed consent form.

Design outcomes

Primary

MeasureTime frameDescription
Clinical improvement during hospitalization24 hours after specific PE treatment implementationIncidence of arterial blood saturation increase \>92%
Ventricular strain reduction24 hours after specific PE treatment implementationRate of right ventricular strain reduction (right ventricle/left ventricle ratio assessment) in echocardiography
Early mortality rate from pulmonary embolismTwo weeks since PE diagnosisNumber of patients who died from pulmonary embolism (right heart failure)

Secondary

MeasureTime frameDescription
Total mortality rate from pulmonary embolism3 months since PE diagnosisNumber of patients who died from pulmonary embolism (right heart failure)
Bleeding events incidence3 months since PE diagnosisIncidence of major bleedings assessed using ISTH criteria

Countries

Poland

Contacts

Primary ContactAleksander Araszkiewicz
aaraszkiewicz@ump.edu.pl8549146
Backup ContactSylwia Sławek-Szmyt
sylwia.slawek@skpp.edu.pl8549293

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026