Polish Multicenter PERTs PE Outcomes Registry (PolPERTs)
Polish Multicenter Pulmonary Embolism Response Teams Outcomes Registry
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Aleksander Araszkiewicz
- Numéro de téléphone: +48 8549146
- E-mail: aaraszkiewicz@ump.edu.pl
Sauvegarde des contacts de l'étude
- Nom: Sylwia Sławek-Szmyt
- Numéro de téléphone: +48 8549293
- E-mail: sylwia.slawek@skpp.edu.pl
Lieux d'étude
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GreaterPoland
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Poznań, GreaterPoland, Pologne, 61-848
- Recrutement
- Poznan University of Medical Sciences
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Contact:
- Aleksander Araszkiewicz, Prof.
- Numéro de téléphone: +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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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
|---|
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Clinical improvement during hospitalization
Délai: 24 hours after specific PE treatment implementation
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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
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Total mortality rate from pulmonary embolism
Délai: 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
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Bleeding events incidence
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Aleksander Araszkiewicz, Prof., Poznan University of Medical Sciences
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 276/21
Informations sur les médicaments et les dispositifs, documents d'étude
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