NCT04879069

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
55mo left

Started Jun 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress63%
Jun 2018Dec 2030

Study Start

First participant enrolled

June 1, 2018

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

May 4, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 10, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
7.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Expected
Last Updated

May 10, 2021

Status Verified

May 1, 2021

Enrollment Period

5 years

First QC Date

May 4, 2021

Last Update Submit

May 4, 2021

Conditions

Pulmonary Embolism With Acute Cor Pulmonale

Keywords

pulmonary embolism, pulmonary embolism response team,

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Total mortality rate from pulmonary embolism

    3 months since PE diagnosis

  • Bleeding events incidence

    3 months since PE diagnosis

Study Arms (2)

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: 1. Cardiac arrest (need for cardiopulmonary resuscitation) or, 2. 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 3. Persistent hypotension (systolic blood pressure \< 90 mmHg for at least 15 minutes)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • \. Refusal to sign the informed consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poznan University of Medical Sciences

Poznan, GreaterPoland, 61-848, Poland

RECRUITING

Related Publications (1)

  • Slawek-Szmyt S, Stepniewski J, Kurzyna M, Klaudel J, Kuliczkowski W, Lewandowski M, Grabka M, Roik M, Ordiene R, Jankiewicz S, Kopec G, Darocha S, Mroczek E, Widecka K, Kurzyna P, Lesiak M, Pruszczyk P, Araszkiewicz A. Multicentre, real-world data of next-generation computer-assisted vacuum aspiration thrombectomy in acute pulmonary embolism. Respir Res. 2025 Mar 5;26(1):87. doi: 10.1186/s12931-025-03162-4.

    PMID: 40045310DERIVED

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Aleksander Araszkiewicz, Prof.

    Poznan University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aleksander Araszkiewicz

CONTACT

8549146aaraszkiewicz@ump.edu.pl

Sylwia Sławek-Szmyt

CONTACT

8549293sylwia.slawek@skpp.edu.pl

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

May 4, 2021

First Posted

May 10, 2021

Study Start

June 1, 2018

Primary Completion

June 1, 2023

Study Completion (Estimated)

December 1, 2030

Last Updated

May 10, 2021

Record last verified: 2021-05

Locations

PL(1)