Acute Pulmonary Embolism Clinical Trial
— PE-aWAREOfficial title:
Pulmonary Embolism WArsaw REgistry
NCT number | NCT03916302 |
Other study ID # | PE-aWARE |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2008 |
Est. completion date | December 31, 2028 |
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.
Status | Recruiting |
Enrollment | 1500 |
Est. completion date | December 31, 2028 |
Est. primary completion date | December 31, 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Poland | Department of Internal Medicine & Cardiology with the Centre for Management of Venous Thromboembolic Disease, Medical University of Warsaw | Warsaw |
Lead Sponsor | Collaborator |
---|---|
Medical University of Warsaw |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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. | 5 years | |
Primary | 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) | |
Primary | 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 | 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) | |
Secondary | 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 |
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