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NCT Number: NCT04879069

Polish Multicenter PERTs PE Outcomes Registry

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Poznan University of Medical Sciences

Poznan, GreaterPoland, 61-848, Poland

Location status: Recruiting

Location contact

Aleksander Araszkiewicz, Prof.

CONTACT

[email protected]

8549149 ext. +48

Sylwia Sławek-Szmyt, MD, PhD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Refusal to sign the informed consent form.

Treatment and study plan

Primary outcomes

  1. Clinical improvement during hospitalization

    Time frame: 24 hours after specific PE treatment implementation

    Incidence of arterial blood saturation increase >92%

  2. Ventricular strain reduction

    Time frame: 24 hours after specific PE treatment implementation

    Rate of right ventricular strain reduction (right ventricle/left ventricle ratio assessment) in echocardiography

  3. Early mortality rate from pulmonary embolism

    Time frame: Two weeks since PE diagnosis

    Number of patients who died from pulmonary embolism (right heart failure)

Secondary outcomes

  1. Total mortality rate from pulmonary embolism

    Time frame: 3 months since PE diagnosis

    Number of patients who died from pulmonary embolism (right heart failure)

  2. Bleeding events incidence

    Time frame: 3 months since PE diagnosis

    Incidence of major bleedings assessed using ISTH criteria

Study contacts

Contact information is provided by the study sponsor or research team.

Aleksander Araszkiewicz

CONTACT

[email protected]

8549146 ext. +48

Sylwia Sławek-Szmyt

CONTACT

[email protected]

8549293 ext. +48

Sponsors and collaborators

Lead sponsor

Poznan University of Medical Sciences

Other

Collaborators

  • Polish Cardiac Society

Registry information

Official study title

Polish Multicenter Pulmonary Embolism Response Teams Outcomes Registry

Acronym: PolPERTs

Important dates

Study start
2018
Primary completion
2023
Study completion
2030
First posted
May 10, 2021
Registry last updated
May 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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