- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03583970
Veno-arterial Extracorporeal Membrane Oxygenation Prior to Left Ventricular Assist Device Implantation. (LVAD-ECMO)
Veno-arterial Extracorporeal Membrane Oxygenation Support Prior to Left Ventricular Assist Device Implantation : Initial Patients Characteristics and 6 Month Follow-up, a Retrospective Study (2013-2017) (LVAD-ECMO)
Cardiogenic shock is an uncommun pathology with a high mortatily rate around 45%. Veno arterial extracorporeal membrane oxygenation (VA-ECMO) is a temporary extracorporeal assist device which restore an adequate blood flow when a circulatory failure occures. VA-ECMO main indication is refractory cardiogenic shock whatever the etiology. Current medical care of terminal cardiac failure includes use of long-term mechanical circulatory support devices (MCSD) such as Left Ventricular Assist Device (LVAD). LVAD therapy may lead to heart transplant (bridge to transplantation), to recovery (bridge to recovery) or to permanent implantation (destination therapy). Few patients with refractory cardiogenic shock treated with VA-ECMO may secondarily need a long term MCSD with LVAD.
LVAD long-term heart assist showed interesting survival rate when implantation occured (71% after 2 years follow-up and 45% after 4 years follow-up) out of acute heart failure situation. There are only few datas concerning LVAD implantion during refractory cardiogenic shock, with a mortality between 20 to 50% in different studies.
In this way, in comparaison of current few datas on the subject of LVAD implantation under VA-ECMO, the investigators (15 french-speacking centers) would retrospectively describe a large population.
연구 개요
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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Nancy, 프랑스, 54000
- 모병
- CHRU Nancy
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연락하다:
- Caroline FRITZ, MD
- 전화번호: +33383157379
- 이메일: c.fritz@chru-nancy.fr
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연락하다:
- Bruno LEVY, MD-PhD
- 전화번호: +33383154469
- 이메일: b.levy@chru-nancy.fr
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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:
- Veno-arterial ExtraCorporeal Membrane Oxygenation prior to left ventricular assist device implantation.
- Veno-arterial ExtraCorporeal Membrane Oxygenation at the left ventricular assist device implantation operative time
Exclusion Criteria:
- ExtraCorporeal Membrane Oxygenation weaving before left ventricular assist device implantation.
- Cardiac assist devices other than Veno-arterial ExtraCorporeal Membrane Oxygenation
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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6-month hospital discharge after LVAD implantation
기간: 6 month after LVAD implantation
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6-month hospital discharge after LVAD implantation
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6 month after LVAD implantation
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Mortality rate
기간: up to six month after LVAD implantation
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Six month mortality rate after LVAD implantation
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up to six month after LVAD implantation
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ICU discharge
기간: up to six month after LVAD implantation
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Days until ICU discharge after LVAD implantation
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up to six month after LVAD implantation
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Quality of life
기간: up to six month after LVAD implantation
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ADL and IADL scale
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up to six month after LVAD implantation
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Hemodynamic Failure
기간: Before LVAD implantation - up to 28 day - up to 6 month
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Amount of Norepinephrine infused
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Before LVAD implantation - up to 28 day - up to 6 month
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Cardiogenic failure
기간: Before LVAD implantation - up to 28 day - up to 6 month
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Amount of inotrope infused
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Before LVAD implantation - up to 28 day - up to 6 month
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Cardio-circulatory failure
기간: Before LVAD implantation - up to 28 day - up to 6 month
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ECLS assistance
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Before LVAD implantation - up to 28 day - up to 6 month
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Renal failure
기간: Before LVAD implantation - up to 28 day - up to 6 month
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Worst KDIGO stage
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Before LVAD implantation - up to 28 day - up to 6 month
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Hepatic failure
기간: Before LVAD implantation - up to 28 day - up to 6 month
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Worst values of PT/bilirubin/ AST and ALT
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Before LVAD implantation - up to 28 day - up to 6 month
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Thrombosis complication
기간: Before LVAD implantation - up to 28 day - up to 6 month
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Thrombosis event
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Before LVAD implantation - up to 28 day - up to 6 month
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Haemorragic complication
기간: Before LVAD implantation - up to 28 day - up to 6 month
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Haemorragic event
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Before LVAD implantation - up to 28 day - up to 6 month
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Respiratory failure
기간: Before LVAD implantation - up to 28 day - up to 6 month
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Ventilation assistance
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Before LVAD implantation - up to 28 day - up to 6 month
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Neurological failure
기간: Before LVAD implantation - up to 28 day - up to 6 month
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neurological sequelae
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Before LVAD implantation - up to 28 day - up to 6 month
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Infection complication
기간: Before LVAD implantation - up to 28 day - up to 6 month
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documented infection
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Before LVAD implantation - up to 28 day - up to 6 month
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공동 작업자 및 조사자
수사관
- 연구 의자: Bruno Levy, MD-PhD, CHRU Nancy
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. .