Pulmonary Embolism WArsaw REgistry

NCT03916302 | Recruiting

• 1 other identifier: PE-aWARE
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

Initiated in January 2008, The PE-aWARE (Pulmonary Embolism WArsaw REgistry) is an on-going single-centre prospective observational study of patients with confirmed acute pulmonary embolism (APE). Extensive data on consecutive patients with pulmonary embolism is collected and stored. The main objective is to collect and provide information on patients' characteristics, management, and outcome with the purpose of decreasing mortality in APE, the occurrence of bleeding, and the frequency of thromboembolic recurrences. Moreover, the PE-aWARE registry serves as a basis for creating predictive scores for clinicians which aid patient management. The study endpoints comprise clinically recognized (and objectively confirmed) recurrences of PE, major and minor bleeding complications classified according to the International Society on Thrombosis and Haemostasis classification, need for cardiopulmonary resuscitation or catecholamines, and death.

Conditions

Acute Pulmonary Embolism

Keywords

acute pulmonary embolism

Outcome Measures

Primary Outcomes (2)

• Composite primary outcome

  at least one of the following: 1. systolic blood pressure \< 90 mmHg for at least 15 minutes 2. need for catecholamine administration because of persistant arterial hypotension or shock 3. need for mechanical ventilation 4. need for cardiopulmonary resuscitation

  in-hospital (average of 10 days)

• Composite primary outcome

  at least one of the following: 1. systolic blood pressure \< 90 mmHg for at least 15 minutes 2. need for catecholamine administration because of persistant arterial hypotension or shock 3. need for mechanical ventilation 4. need for cardiopulmonary resuscitation

  within 30 days from diagnosis

Secondary Outcomes (2)

• Major or non-major clinically relevant bleeding defined according to the International Society on Thrombosis and Haemostasis

  in-hospital (average of 10 days)

• Major or non-major clinically relevant bleeding defined according to the International Society on Thrombosis and Haemostasis

  within 30 days from diagnosis

Other Outcomes (1)

• 5-year follow-up

  5 years

Study Arms (2)

Complicated outcome

The patients meet at least one of the following criteria: 1. systolic blood pressure \< 90 mmHg for at least 15 minutes 2. need for catecholamine administration because of persistant arterial hypotension or shock 3. need for mechanical ventilation 4. need for cardiopulmonary resuscitation 5. bleeding classified according to the International Society on Thrombosis and Haemostasis classification (major bleeding and non-major clinically relevant bleeding).

Non-complicated outcome

The patients meet none of the following criteria: 1. systolic blood pressure \< 90 mmHg for at least 15 minutes 2. need for catecholamine administration because of persistant arterial hypotension or shock 3. need for mechanical ventilation 4. need for cardiopulmonary resuscitation 5. bleeding classified according to the International Society on Thrombosis and Haemostasis classification (major bleeding and non-major clinically relevant bleeding).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Concecutive patients hospitalized for pulmonary embolism

You may qualify if:

• objectively confirmed pulmonary embolism
• Informed consent for the participation in the study, according to the requirements of the ethics committee

You may not qualify if:

• lack of consent

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Department of Internal Medicine & Cardiology with the Centre for Management of Venous Thromboembolic Disease, Medical University of Warsaw

Warsaw, 02-005, Poland

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

Study Officials

• Piotr Pruszczyk, Prof.

  Medical University of Warsaw

  STUDY DIRECTOR

Central Study Contacts

Piotr Pruszczyk, Prof.

CONTACT

00 48 22 502 11 44; piotr.pruszczyk@wum.edu.pl

Marta Z Skowronska, MD

CONTACT

00 48 22 502 16 25; marta.z.kozlowska@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: April 12, 2019
• First Posted: April 16, 2019
• Study Start: January 1, 2008
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: October 27, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)