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Clinical Trial Details — Status: Recruiting

Administrative data

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

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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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