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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Complicated outcome | The patients meet at least one of the following criteria:
| ||
| Non-complicated outcome | The patients meet none of the following criteria:
|
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| Measure | Description | Time Frame |
|---|---|---|
| Composite primary outcome | at least one of the following:
| in-hospital (average of 10 days) |
| Composite primary outcome | at least one of the following:
| within 30 days from diagnosis |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 5-year follow-up | 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. |
Inclusion Criteria:
Exclusion Criteria:
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Concecutive patients hospitalized for pulmonary embolism
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Piotr Pruszczyk, Prof. | Medical University of Warsaw | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Internal Medicine & Cardiology with the Centre for Management of Venous Thromboembolic Disease, Medical University of Warsaw | Recruiting | Warsaw | 02-005 | Poland |
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serum
Secondary outcome measure |
| within 30 days from diagnosis |
| 5 years |
|