Polish Multicenter PERTs PE Outcomes Registry (PolPERTs)
Polish Multicenter Pulmonary Embolism Response Teams Outcomes Registry
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studiecontact
- Naam: Aleksander Araszkiewicz
- Telefoonnummer: +48 8549146
- E-mail: aaraszkiewicz@ump.edu.pl
Studie Contact Back-up
- Naam: Sylwia Sławek-Szmyt
- Telefoonnummer: +48 8549293
- E-mail: sylwia.slawek@skpp.edu.pl
Studie Locaties
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GreaterPoland
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Poznań, GreaterPoland, Polen, 61-848
- Werving
- Poznan University of Medical Sciences
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Contact:
- Aleksander Araszkiewicz, Prof.
- Telefoonnummer: +48 8549149
- E-mail: aaraszkiewicz@ump.edu.pl
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Contact:
- Sylwia Sławek-Szmyt, MD, PhD
- E-mail: sylwia.slawek@skpp.edu.pl
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- PE confirmed by computed tomography pulmonary angiography.
- PE symptoms duration ≤ 14 days.
High-risk PE with hemodynamic instability (one of):
- cardiac arrest
- obstructive shock
- persistent hypotension.
- 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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
|---|
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Intermediate-high risk PE
Confirmed PE causing right ventricle dysfunction confirmed by computed tomography pulmonary angiography or transthoracic echocardiography and elevated troponin level
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High-risk PE
Confirmed PE causing hemodynamic instability:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Clinical improvement during hospitalization
Tijdsspanne: 24 hours after specific PE treatment implementation
|
Incidence of arterial blood saturation increase >92%
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24 hours after specific PE treatment implementation
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Ventricular strain reduction
Tijdsspanne: 24 hours after specific PE treatment implementation
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Rate of right ventricular strain reduction (right ventricle/left ventricle ratio assessment) in echocardiography
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24 hours after specific PE treatment implementation
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Early mortality rate from pulmonary embolism
Tijdsspanne: Two weeks since PE diagnosis
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Number of patients who died from pulmonary embolism (right heart failure)
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Two weeks since PE diagnosis
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Total mortality rate from pulmonary embolism
Tijdsspanne: 3 months since PE diagnosis
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Number of patients who died from pulmonary embolism (right heart failure)
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3 months since PE diagnosis
|
|
Bleeding events incidence
Tijdsspanne: 3 months since PE diagnosis
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Incidence of major bleedings assessed using ISTH criteria
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3 months since PE diagnosis
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Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Aleksander Araszkiewicz, Prof., Poznan University of Medical Sciences
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 276/21
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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