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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04480151
Acronym
ECI-BLAD
Enrollment
92
Registered
2020-07-21
Start date
2021-01-20
Completion date
2021-04-21
Last updated
2021-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiogenic Shock, End-stage Heart Failure

Keywords

cardiogenic shock, end stage heart failure, bridge to bridge, bridge to decision, left ventricular assist device, IMPELLA™, ECLS

Brief summary

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).

Detailed description

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)

Interventions

OTHERstandard of care

retrospective study: standard of care

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 implantationDay 30 after Left Ventricular Assist Device (LVAD) implantationProportion 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

MeasureTime frameDescription
Organ dysfunction before LVAD implantationThe day before LVAD implantationNeed for mechanical ventilation, Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score \[0= best outcome to 24 = worst outcome\]
complication Under LVADThe day of Intensive Care Unit (ICU) dischargebleeding, right ventricular dysfunction, vasoplegia
Complication and rehabilitation under Short-term Mechanical Circulatory supportThe day of Left Ventricular Assist Device (LVAD) implantationDuration of support, bleeding, hemolysis, surgical re-exploration, thombus, renal replacement therapy, blood products transfusion, stroke, tracheal extubation, mobilization (chair, walking and ergometry)
Vital status1 month after LVAD implantationmortality after LVAD implantation
length of stayup to Intensive Care Unit (ICU) discharge (not more than 6 months after LVAD implantation)Intensive Care Unit length of stay
SOFA scoreThe day of Short Term Mechanical Circulatory Support (STMCS) implantationOrgan dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score \[0= best outcome to 24 = worst outcome\]

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026