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临床试验/NCT04480151
NCT04480151已完成不适用

ExtraCorporeal Life Support (ECLS) Versus IMPELLA™ Pump as Bridge to Left Ventricular Assist Device

University Hospital, Bordeaux5 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2021年1月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
92
试验地点
5
主要终点
Proportion of patients alive in the surgery ward, not requiring intravenous access and walking (John Hopkins highest level of mobility (JH-HLM) scale = 8 at 30 days after the LVAD implantation

研究概览

简要总结

In this retrospective observational multicenter study the authors tested the hypothesis that the use of IMPELLA™ pump as bridge to bridge, by giving the opportunity of active rehabilitation, should improve patient's outcomes after the implantation of Left Ventricular Assist Device (LVAD).

详细描述

End stage heart failure patients admitted in Intensive Care Unit (ICU) for refractory cardiogenic shock requiring short-term mechanical circulatory support as a bridge to a long-term LVAD might benefit from early mobilization and rehabilitation with IMPELLA™ inserted via the axillary artery. The aim of this study is to compare the early rehabilitation and outcomes after LVAD implantation between patients previously treated by IMPELLA™ or ExtraCorporeal Life Support (ECLS)

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients supported with IMPELLA™ or ECLS for refractory cardiogenic shock as a bridge to long duration LVAD

排除标准

  • Patient refusing to give access to their medical chart
  • Guardianship and curactorship
  • Deprived of liberty
  • short term mechanical circulatory system weaned before LVAD implantation

结局指标

主要结局

Proportion of patients alive in the surgery ward, not requiring intravenous access and walking (John Hopkins highest level of mobility (JH-HLM) scale = 8 at 30 days after the LVAD implantation

时间窗: Day 30 after Left Ventricular Assist Device (LVAD) implantation

Proportion of patients alive in the surgery ward, not requiring intravenous access and walking (John Hopkins highest level of mobility (JH-HLM) scale = 8) at 30 days after the LVAD implantation

次要结局

  • Organ dysfunction before LVAD implantation(The day before LVAD implantation)
  • SOFA score(Day 7 post LVAD implantation)
  • length of stay(up to hospital discharge (not more than 6 months after LVAD implantation))
  • Complication and rehabilitation under Short-term Mechanical Circulatory support(The day of Left Ventricular Assist Device (LVAD) implantation)
  • complication Under LVAD(The day of Intensive Care Unit (ICU) discharge)
  • Vital status(6 months after LVAD implantation)

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (5)

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