Clinical trial NCT03916302: Pulmonary Embolism WArsaw REgistry
Official title: Pulmonary Embolism WArsaw REgistry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Pulmonary Embolism
Keywords: acute pulmonary embolism
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Concecutive patients hospitalized for pulmonary embolism

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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite primary outcome
timeFrame: in-hospital (average of 10 days)
measure: Composite primary outcome
timeFrame: within 30 days from diagnosis
Secondary outcomes:
measure: Major or non-major clinically relevant bleeding defined according to the International Society on Thrombosis and Haemostasis
timeFrame: in-hospital (average of 10 days)
measure: Major or non-major clinically relevant bleeding defined according to the International Society on Thrombosis and Haemostasis
timeFrame: within 30 days from diagnosis
Other outcomes:
measure: 5-year follow-up
timeFrame: 5 years
Locations:
city: Warsaw
country: Poland
facility: Department of Internal Medicine & Cardiology with the Centre for Management of Venous Thromboembolic Disease, Medical University of Warsaw
Study officials:
affiliation: Medical University of Warsaw
name: Piotr Pruszczyk, Prof.
role: STUDY_DIRECTOR
References: