Polish Multicenter PERTs PE Outcomes Registry (PolPERTs)

Polish Multicenter Pulmonary Embolism Response Teams 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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Embolism With Acute Cor Pulmonale

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.

• Study Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

• Study Contact: Name: Aleksander Araszkiewicz; Phone Number: +48 8549146; Email: aaraszkiewicz@ump.edu.pl
• Study Contact Backup: Name: Sylwia Sławek-Szmyt; Phone Number: +48 8549293; Email: sylwia.slawek@skpp.edu.pl

Study Locations

• Poland
  • GreaterPoland
    • Poznań, GreaterPoland, Poland, 61-848
      • Recruiting
      • Poznan University of Medical Sciences
      • Contact: Aleksander Araszkiewicz, Prof.; Phone Number: +48 8549149; Email: aaraszkiewicz@ump.edu.pl
      • Contact: Sylwia Sławek-Szmyt, MD, PhD; Email: sylwia.slawek@skpp.edu.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients hospitalized due to high-risk or intermediate-high risk PE.

Description

Inclusion Criteria:

1. PE confirmed by computed tomography pulmonary angiography.
2. PE symptoms duration ≤ 14 days.

3. High-risk PE with hemodynamic instability (one of):

   • cardiac arrest
   • obstructive shock
   • persistent hypotension.
4. 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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: Cardiac arrest (need for cardiopulmonary resuscitation) or,; Obstructive shock (systolic blood pressure < 90 mmHg or vasopressors required to achieve a systolic blood pressure ≥90 mmHg despite adequate filling status and end-organ hypoperfusion), or; Persistent hypotension (systolic blood pressure < 90 mmHg for at least 15 minutes)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical improvement during hospitalization	Incidence of arterial blood saturation increase >92%	24 hours after specific PE treatment implementation
Ventricular strain reduction	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	Number of patients who died from pulmonary embolism (right heart failure)	Two weeks since PE diagnosis

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total mortality rate from pulmonary embolism	Number of patients who died from pulmonary embolism (right heart failure)	3 months since PE diagnosis
Bleeding events incidence	Incidence of major bleedings assessed using ISTH criteria	3 months since PE diagnosis

Collaborators and Investigators

• Sponsor: Poznan University of Medical Sciences
• Collaborators: Polish Cardiac Society
• Investigators: Principal Investigator: Aleksander Araszkiewicz, Prof., Poznan University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): December 1, 2030

Study Registration Dates

• First Submitted: May 4, 2021
• First Submitted That Met QC Criteria: May 4, 2021
• First Posted (Actual): May 10, 2021

Study Record Updates

• Last Update Posted (Actual): May 10, 2021
• Last Update Submitted That Met QC Criteria: May 4, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: pulmonary embolism, pulmonary embolism response team,
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Pulmonary Embolism; Pulmonary Heart Disease
• Other Study ID Numbers: 276/21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No