- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04879069
Polish Multicenter PERTs PE Outcomes Registry (PolPERTs)
Polish Multicenter Pulmonary Embolism Response Teams Outcomes Registry
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studiekontakt
- Namn: Aleksander Araszkiewicz
- Telefonnummer: +48 8549146
- E-post: aaraszkiewicz@ump.edu.pl
Studera Kontakt Backup
- Namn: Sylwia Sławek-Szmyt
- Telefonnummer: +48 8549293
- E-post: sylwia.slawek@skpp.edu.pl
Studieorter
-
-
GreaterPoland
-
Poznań, GreaterPoland, Polen, 61-848
- Rekrytering
- Poznan University of Medical Sciences
-
Kontakt:
- Aleksander Araszkiewicz, Prof.
- Telefonnummer: +48 8549149
- E-post: aaraszkiewicz@ump.edu.pl
-
Kontakt:
- Sylwia Sławek-Szmyt, MD, PhD
- E-post: sylwia.slawek@skpp.edu.pl
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / 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:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Clinical improvement during hospitalization
Tidsram: 24 hours after specific PE treatment implementation
|
Incidence of arterial blood saturation increase >92%
|
24 hours after specific PE treatment implementation
|
Ventricular strain reduction
Tidsram: 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
Tidsram: Two weeks since PE diagnosis
|
Number of patients who died from pulmonary embolism (right heart failure)
|
Two weeks since PE diagnosis
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Total mortality rate from pulmonary embolism
Tidsram: 3 months since PE diagnosis
|
Number of patients who died from pulmonary embolism (right heart failure)
|
3 months since PE diagnosis
|
Bleeding events incidence
Tidsram: 3 months since PE diagnosis
|
Incidence of major bleedings assessed using ISTH criteria
|
3 months since PE diagnosis
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Aleksander Araszkiewicz, Prof., Poznan University of Medical Sciences
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 276/21
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