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NCT Number: NCT03916302

Pulmonary Embolism WArsaw REgistry

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.

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Key information

Conditions

Acute Pulmonary Embolism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Warsaw, 02-005, Poland

Location status: Recruiting

Location contact

Marta Z Skowronska, MD

CONTACT

[email protected]

00 48 22 502 16 25

Marta Z Skowronska, MD

SUB_INVESTIGATOR

Piotr Pruszczyk, Prof.

CONTACT

[email protected]

00 48 22 502 11 44

Piotr Pruszczyk, Prof.

PRINCIPAL_INVESTIGATOR

About this study

The Pulmonary Embolism WArsaw REgistry (PE-aWARE) is an on-going prospective observational study of patients with confirmed acute pulmonary embolism (APE). Carried out since January 2008, the registry includes consecutive patients hospitalized at a single centre. The primary data recorded include details of each patient's clinical status, co-morbidities, the prescribed treatment, the results of additional studies (ie EKG, imaging studies), and the outcome. 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.

Collecting the fore mentioned data allows for clinicians to better manage the diagnostic workup and treatment and thus facilitates the prevention of possible future complications in APE patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • lack of consent

Treatment and study plan

Primary outcomes

  1. Composite primary outcome

    Time frame: in-hospital (average of 10 days)

    at least one of the following:

    • systolic blood pressure < 90 mmHg for at least 15 minutes
    • need for catecholamine administration because of persistant arterial hypotension or shock
    • need for mechanical ventilation
    • need for cardiopulmonary resuscitation

  2. Composite primary outcome

    Time frame: within 30 days from diagnosis

    at least one of the following:

    • systolic blood pressure < 90 mmHg for at least 15 minutes
    • need for catecholamine administration because of persistant arterial hypotension or shock
    • need for mechanical ventilation
    • need for cardiopulmonary resuscitation

Secondary outcomes

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

    Time frame: in-hospital (average of 10 days)

    Secondary outcome measure

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

    Time frame: within 30 days from diagnosis

    Secondary outcome measure

Other outcomes

  1. 5-year follow-up

    Time frame: 5 years

    Patients will be evaluated annually at least during first 5 years after index PE for VTE recurrence and for Post PE syndrome (PPS) including chronic thromboembolic pulmonary hypertension (CTEPH), chronic thromboembolic pulmonary disease (CTEPD), newly diagnosed neoplasms, cardiovascular diseases (coronary artery disease, stroke, heart failure) and functional limitation resulting from psychological sequel of acute PE.

Study contacts

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

Marta Z Skowronska, MD

CONTACT

[email protected]

00 48 22 502 16 25

Piotr Pruszczyk, Prof.

CONTACT

[email protected]

00 48 22 502 11 44

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Acronym: PE-aWARE

Important dates

Study start
2008
Primary completion
2028
Study completion
2028
First posted
Apr 16, 2019
Registry last updated
Oct 27, 2023

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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