Pulmonary Embolism WArsaw REgistry
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 1,500
- Locations
- 1
- Primary Endpoint
- Composite primary outcome
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Composite primary outcome
Time Frame: within 30 days from diagnosis
at least one of the following: 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
Secondary Outcomes
- Major or non-major clinically relevant bleeding defined according to the International Society on Thrombosis and Haemostasis(within 30 days from diagnosis)
Investigators
Piotr Pruszczyk
Prof.
Medical University of Warsaw