Pulmonary Embolism WArsaw REgistry

Acute Pulmonary Embolism Clinical Trial

— PE-aWARE  

Official title:

Pulmonary Embolism WArsaw REgistry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03916302
• Other study ID #: PE-aWARE
• Status: Recruiting
• Start date: January 1, 2008
• Est. completion date: December 31, 2028

Study information

• Verified date: October 2023
• Source: Medical University of Warsaw
• Contact: Piotr Pruszczyk, Prof.
• Phone: 00 48 22 502 11 44
• Email: piotr.pruszczyk[@]wum.edu.pl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Acute Pulmonary Embolism
• Embolism
• Pulmonary Embolism

Locations

Country	Name	City	State
Poland	Department of Internal Medicine & Cardiology with the Centre for Management of Venous Thromboembolic Disease, Medical University of Warsaw	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

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