Polish Multicenter PERTs PE Outcomes Registry (PolPERTs)
Polish Multicenter Pulmonary Embolism Response Teams Outcomes Registry
연구 개요
상태
상세 설명
Pulmonary embolism (PE) is the third leading cause of cardiovascular mortality. The presentation of PE may vary from asymptomatic or mild exertion disturbances (low-risk PE) treated with anticoagulants only to hemodynamic "obstructive" collapse and death (high-risk PE). Patient outcome depends on ability of the right ventricle to sustain the increased afterload caused by the embolic burden. Careful risk stratification is crucial, and the Pulmonary Embolism Response Team (PERT) concept offers a rapid and multidisciplinary approach focused on improving outcomes for patients with PE by advancing its recognition, diagnosis, and treatment. All institutionalized PERTs in Poland have been invited to join the study. The data is administrated by the Poznan University of Medical Sciences on the basis of an agreement between the PERT centres.
The goal of this registry is to describe current practice and outcomes in patients with acute PE guided by Polish PERTs. The primary data recorded include details of each patient's clinical status, co-morbidities, the administered treatment modalities, the results of additional studies (ab tests results, ECG, imaging studies), and the outcome.
The data collection will have no impact on the way the patient is diagnosed and treated.The study endpoints comprise respiratory failure, shock, death distal systemic embolization (i.e. stroke) and major or minor bleeding complications classified according to the International Society on Thrombosis and Haemostasis classification.
연구 유형
등록 (예상)
연락처 및 위치
연구 연락처
- 이름: Aleksander Araszkiewicz
- 전화번호: +48 8549146
- 이메일: aaraszkiewicz@ump.edu.pl
연구 연락처 백업
- 이름: Sylwia Sławek-Szmyt
- 전화번호: +48 8549293
- 이메일: sylwia.slawek@skpp.edu.pl
연구 장소
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GreaterPoland
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Poznań, GreaterPoland, 폴란드, 61-848
- 모병
- Poznan University of Medical Sciences
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연락하다:
- Aleksander Araszkiewicz, Prof.
- 전화번호: +48 8549149
- 이메일: aaraszkiewicz@ump.edu.pl
-
연락하다:
- Sylwia Sławek-Szmyt, MD, PhD
- 이메일: sylwia.slawek@skpp.edu.pl
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-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- PE confirmed by computed tomography pulmonary angiography.
- PE symptoms duration ≤ 14 days.
High-risk PE with hemodynamic instability (one of):
- cardiac arrest
- obstructive shock
- persistent hypotension.
- Intermediate-high risk PE patients with right ventricle dysfunction confirmed by imaging studies and elevated troponin level.
Exclusion Criteria:
1. Refusal to sign the informed consent form.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
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Intermediate-high risk PE
Confirmed PE causing right ventricle dysfunction confirmed by computed tomography pulmonary angiography or transthoracic echocardiography and elevated troponin level
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High-risk PE
Confirmed PE causing hemodynamic instability:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Clinical improvement during hospitalization
기간: 24 hours after specific PE treatment implementation
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Incidence of arterial blood saturation increase >92%
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24 hours after specific PE treatment implementation
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Ventricular strain reduction
기간: 24 hours after specific PE treatment implementation
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Rate of right ventricular strain reduction (right ventricle/left ventricle ratio assessment) in echocardiography
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24 hours after specific PE treatment implementation
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Early mortality rate from pulmonary embolism
기간: Two weeks since PE diagnosis
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Number of patients who died from pulmonary embolism (right heart failure)
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Two weeks since PE diagnosis
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Total mortality rate from pulmonary embolism
기간: 3 months since PE diagnosis
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Number of patients who died from pulmonary embolism (right heart failure)
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3 months since PE diagnosis
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Bleeding events incidence
기간: 3 months since PE diagnosis
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Incidence of major bleedings assessed using ISTH criteria
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3 months since PE diagnosis
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공동 작업자 및 조사자
수사관
- 수석 연구원: Aleksander Araszkiewicz, Prof., Poznan University of Medical Sciences
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .