Pulmonary Embolism WArsaw REgistry (PE-aWARE)

Medical University of Warsaw

Status: Enrolling

Conditions: Acute Pulmonary Embolism

Study type: Observational

Funder types: Other

Identifiers

NCT03916302

PE-aWARE

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,500 participants in 2 patient groups

Complicated outcome

Description:

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

Description:

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).