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Completed

NCT Number: NCT04480151

ECLS Versus IMPELLA™ as Bridge to LVAD (ECI-BLAD)

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).

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Key information

Conditions

Cardiogenic Shock Cardiovascular Diseases End-stage Heart Failure Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Shock, Cardiogenic Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Dijon-Bourgoigne, Dijon, France

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Standard of care

Other

retrospective study: standard of care

Primary outcomes

  1. 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

    Time frame: 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

Secondary outcomes

  1. Complication and rehabilitation under Short-term Mechanical Circulatory support

    Time frame: The day of Left Ventricular Assist Device (LVAD) implantation

    Duration of support, bleeding, hemolysis, surgical re-exploration, thombus, renal replacement therapy, blood products transfusion, stroke, tracheal extubation, mobilization (chair, walking and ergometry)

  2. Organ dysfunction before LVAD implantation

    Time frame: The day before LVAD implantation

    Need for mechanical ventilation, Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score [0= best outcome to 24 = worst outcome]

  3. complication Under LVAD

    Time frame: The day of Intensive Care Unit (ICU) discharge

    bleeding, right ventricular dysfunction, vasoplegia

  4. SOFA score

    Time frame: The day of Short Term Mechanical Circulatory Support (STMCS) implantation

    Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score [0= best outcome to 24 = worst outcome]

  5. SOFA score

    Time frame: The day of LVAD implantation

    Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score [0= best outcome to 24 = worst outcome]

  6. SOFA score

    Time frame: Day 1 post LVAD implantation

    Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score [0= best outcome to 24 = worst outcome]

  7. SOFA score

    Time frame: Day 3 post LVAD implantation

    Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score [0= best outcome to 24 = worst outcome]

  8. SOFA score

    Time frame: Day 5 post LVAD implantation

    Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score [0= best outcome to 24 = worst outcome]

  9. SOFA score

    Time frame: Day 7 post LVAD implantation

    Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score [0= best outcome to 24 = worst outcome]

  10. Vital status

    Time frame: 1 month after LVAD implantation

    mortality after LVAD implantation

  11. Vital status

    Time frame: 3 months after LVAD implantation

    mortality after LVAD implantation

  12. Vital status

    Time frame: 6 months after LVAD implantation

    mortality after LVAD implantation

  13. length of stay

    Time frame: up to Intensive Care Unit (ICU) discharge (not more than 6 months after LVAD implantation)

    Intensive Care Unit length of stay

  14. length of stay

    Time frame: up to hospital discharge (not more than 6 months after LVAD implantation)

    hospital length of stay

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

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

Acronym: ECI-BLAD

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 21, 2020
Registry last updated
Jul 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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