Clinical Trials Directory

Trials / Recruiting

RecruitingNCT04879069

Polish Multicenter PERTs PE Outcomes Registry

Polish Multicenter Pulmonary Embolism Response Teams Outcomes Registry

Status
Recruiting
Phase
Study type
Observational
Enrollment
10,000 (estimated)
Sponsor
Poznan University of Medical Sciences · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Pulmonary embolism (PE) is the third leading cause of cardiovascular mortality. The Pulmonary Embolism Response Team (PERT) concept offers a rapid and multidisciplinary approach focused on improving outcomes for patients with PE. All institutionalized PERTs in Poland have been invited to join the study. The goal of this registry is to describe current practice and outcomes in patients with acute PE treated by Polish PERTs.

Detailed description

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.

Conditions

Timeline

Start date
2018-06-01
Primary completion
2023-06-01
Completion
2030-12-01
First posted
2021-05-10
Last updated
2021-05-10

Locations

1 site across 1 country: Poland

Source: ClinicalTrials.gov record NCT04879069. Inclusion in this directory is not an endorsement.