Polish Multicenter PERTs PE Outcomes Registry (PolPERTs)
Polish Multicenter Pulmonary Embolism Response Teams Outcomes Registry
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiekontakt
- Navn: Aleksander Araszkiewicz
- Telefonnummer: +48 8549146
- E-mail: aaraszkiewicz@ump.edu.pl
Undersøgelse Kontakt Backup
- Navn: Sylwia Sławek-Szmyt
- Telefonnummer: +48 8549293
- E-mail: sylwia.slawek@skpp.edu.pl
Studiesteder
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GreaterPoland
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Poznań, GreaterPoland, Polen, 61-848
- Rekruttering
- Poznan University of Medical Sciences
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Kontakt:
- Aleksander Araszkiewicz, Prof.
- Telefonnummer: +48 8549149
- E-mail: aaraszkiewicz@ump.edu.pl
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Kontakt:
- Sylwia Sławek-Szmyt, MD, PhD
- E-mail: sylwia.slawek@skpp.edu.pl
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
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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
|
|
High-risk PE
Confirmed PE causing hemodynamic instability:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Clinical improvement during hospitalization
Tidsramme: 24 hours after specific PE treatment implementation
|
Incidence of arterial blood saturation increase >92%
|
24 hours after specific PE treatment implementation
|
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Ventricular strain reduction
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Total mortality rate from pulmonary embolism
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Aleksander Araszkiewicz, Prof., Poznan University of Medical Sciences
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 276/21
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