Pulmonary Embolism WArsaw REgistry

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pulmonary Embolism WArsaw REgistry

Conditions
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Acute Pulmonary Embolism

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Complicated outcome<br>The patients meet at least one of the following criteria: 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 bleeding classified according to the International Society on Thrombosis and Haemostasis classification (major bleeding and non-major clinically relevant bleeding). | |
| Non-complicated outcome<br>The patients meet none of the following criteria: 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 bleeding classified according to the International Society on Thrombosis and Haemostasis classification (major bleeding and non-major clinically relevant bleeding). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite primary outcome | 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 | in-hospital (average of 10 days) | 
| Composite primary outcome | 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 | within 30 days from diagnosis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major or non-major clinically relevant bleeding defined according to the International Society on Thrombosis and Haemostasis | Secondary outcome measure | in-hospital (average of 10 days) | 
| Major or non-major clinically relevant bleeding defined according to the International Society on Thrombosis and Haemostasis | Secondary outcome measure | within 30 days from diagnosis | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute pulmonary embolism