Pulmonary Embolism WArsaw REgistry
ConditionAcute Pulmonary Embolism
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedical University of Warsaw
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
objectively confirmed pulmonary embolism
Informed consent for the participation in the study, according to the requirements of the ethics committee
Disqualifiers
lack of consent
Trial population
Concecutive patients hospitalized for pulmonary embolism
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,500 Participants
are grouped into 2 trial groupsGroup A: Complicated outcome
Group B: Non-complicated outcome
Trial outcomes
Primary outcomes
1
Composite primary outcome
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
Time frame
in-hospital (average of 10 days)2
Composite primary outcome
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
Time frame
within 30 days from diagnosisSecondary outcomes
1
Major or non-major clinically relevant bleeding defined according to the International Society on Thrombosis and Haemostasis
Secondary outcome measure
Time frame
in-hospital (average of 10 days)2
Major or non-major clinically relevant bleeding defined according to the International Society on Thrombosis and Haemostasis
Secondary outcome measure
Time frame
within 30 days from diagnosisOther outcomes
1
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.
Time frame
5 yearsSponsors and contacts
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Source ClinicalTrials.gov