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Pulmonary Embolism WArsaw REgistry (PE-aWARE)

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ClinicalTrials.gov Identifier: NCT03916302
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Piotr Pruszczyk, Medical University of Warsaw

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.

Condition or disease
Acute Pulmonary Embolism

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 30 Days
Official Title: Pulmonary Embolism WArsaw REgistry
Actual Study Start Date : January 1, 2008
Estimated Primary Completion Date : December 31, 2028
Estimated Study Completion Date : December 31, 2028

Resource links provided by the National Library of Medicine


Group/Cohort
Complicated outcome

The patients meet at least one of the following criteria:

  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
  5. bleeding classified according to the International Society on Thrombosis and Haemostasis classification (major bleeding and non-major clinically relevant bleeding).
Non-complicated outcome

The patients meet none of the following criteria:

  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
  5. bleeding classified according to the International Society on Thrombosis and Haemostasis classification (major bleeding and non-major clinically relevant bleeding).



Primary Outcome Measures :
  1. Composite primary outcome [ Time Frame: in-hospital (average of 10 days) ]

    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

  2. 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 Outcome Measures :
  1. Major or non-major clinically relevant bleeding defined according to the International Society on Thrombosis and Haemostasis [ Time Frame: in-hospital (average of 10 days) ]
    Secondary outcome measure

  2. Major or non-major clinically relevant bleeding defined according to the International Society on Thrombosis and Haemostasis [ Time Frame: within 30 days from diagnosis ]
    Secondary outcome measure


Biospecimen Retention:   Samples Without DNA
serum


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Concecutive patients hospitalized for pulmonary embolism
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03916302


Contacts
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Contact: Piotr Pruszczyk, Prof. 00 48 22 502 11 44 piotr.pruszczyk@wum.edu.pl
Contact: Marta Z Skowronska, MD 00 48 22 502 16 25 marta.z.kozlowska@gmail.com

Locations
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Poland
Department of Internal Medicine & Cardiology with the Centre for Management of Venous Thromboembolic Disease, Medical University of Warsaw Recruiting
Warsaw, Poland, 02-005
Contact: Piotr Pruszczyk, Prof.    00 48 22 502 11 44    piotr.pruszczyk@wum.edu.pl   
Contact: Marta Z Skowronska, MD    00 48 22 502 16 25    marta.z.kozlowska@gmail.com   
Principal Investigator: Piotr Pruszczyk, Prof.         
Sub-Investigator: Marta Z Skowronska, MD         
Sponsors and Collaborators
Medical University of Warsaw
Investigators
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Study Director: Piotr Pruszczyk, Prof. Medical University of Warsaw

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Responsible Party: Piotr Pruszczyk, Prof., Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT03916302     History of Changes
Other Study ID Numbers: PE-aWARE
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Piotr Pruszczyk, Medical University of Warsaw:
acute pulmonary embolism

Additional relevant MeSH terms:
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Embolism
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases