Polish Multicenter PERTs PE Outcomes Registry (PolPERTs)
Polish Multicenter Pulmonary Embolism Response Teams Outcomes Registry
Studieoversikt
Status
Detaljert 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.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiekontakt
- Navn: Aleksander Araszkiewicz
- Telefonnummer: +48 8549146
- E-post: aaraszkiewicz@ump.edu.pl
Studer Kontakt Backup
- Navn: Sylwia Sławek-Szmyt
- Telefonnummer: +48 8549293
- E-post: sylwia.slawek@skpp.edu.pl
Studiesteder
-
-
GreaterPoland
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Poznań, GreaterPoland, Polen, 61-848
- Rekruttering
- Poznan University of Medical Sciences
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Ta kontakt med:
- Aleksander Araszkiewicz, Prof.
- Telefonnummer: +48 8549149
- E-post: aaraszkiewicz@ump.edu.pl
-
Ta kontakt med:
- Sylwia Sławek-Szmyt, MD, PhD
- E-post: sylwia.slawek@skpp.edu.pl
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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 studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
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:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
|
|
Ventricular strain reduction
Tidsramme: 24 hours after specific PE treatment implementation
|
Rate of right ventricular strain reduction (right ventricle/left ventricle ratio assessment) in echocardiography
|
24 hours after specific PE treatment implementation
|
|
Early mortality rate from pulmonary embolism
Tidsramme: Two weeks since PE diagnosis
|
Number of patients who died from pulmonary embolism (right heart failure)
|
Two weeks since PE diagnosis
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Total mortality rate from pulmonary embolism
Tidsramme: 3 months since PE diagnosis
|
Number of patients who died from pulmonary embolism (right heart failure)
|
3 months since PE diagnosis
|
|
Bleeding events incidence
Tidsramme: 3 months since PE diagnosis
|
Incidence of major bleedings assessed using ISTH criteria
|
3 months since PE diagnosis
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Aleksander Araszkiewicz, Prof., Poznan University of Medical Sciences
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 276/21
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