Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2026-01-22 @ 2:01 AM
Study NCT ID:
NCT03916302
Status:
RECRUITING
Last Update Posted:
2023-10-27
First Post:
2019-04-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulmonary Embolism WArsaw REgistry
Sponsor:
Medical University of Warsaw
Organization:
Study Overview
Official Title:
Pulmonary Embolism WArsaw REgistry
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PE-aWARE
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: