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Cardiogenic ShockECI-BLADNCT04480151

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

An observational study of Cardiogenic Shock and End-stage Heart Failure, run by University Hospital, Bordeaux at 5 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiogenic Shock, End-stage Heart Failure
How many people
92 participants
Where
5 sitesFrance
Study dates
20 Jan 2021to 21 Apr 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: consecutive patients implanted by IMPELLA™ pump or ECLS as a bridge to long duration LVAD between January 2012 and December 2018 in five university hospital centers.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

France5 sites

  • CHU de Dijon-Bourgoigne

    Dijon, 21079

  • CHU de Montpellier

    Montpellier, 34295

  • CHU de Bordeaux

    Pessac, 33604

  • CHU de Rennes

    Rennes, 35000

  • CHU de Toulouse

    Toulouse, 31059

Other trials in France

About this study

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

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).

Read the 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)

Being tested
standard of care
Keywords
cardiogenic shock, end stage heart failure, bridge to bridge, bridge to decision, left ventricular assist device, IMPELLA™, ECLS
Medical subject headings
Shock, Cardiogenic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • standard of careOther

    retrospective study: standard of care

Study groups in NCT04480151
Study groupRoleWhat they receive
IMPELLA™ alone as bridge to LVADpatients assisted by IMPELLA™ pump alone during the days preceding the implantation of long term LVAD (at least 48 hours for patients for whom an ECLS was previously used)
Receives: Other: standard of care
ECLS alone or with IMPELLA™ as bridge to LVADpatients assisted by ECLS (ExtraCorporeal life support) alone or simultaneously with IMPELLA™ until the implantation of LVAD
Receives: Other: standard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    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

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

Secondary outcomes (14)

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

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

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

  2. Organ dysfunction before LVAD implantation

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

    Measured: The day before LVAD implantation

  3. complication Under LVAD

    bleeding, right ventricular dysfunction, vasoplegia

    Measured: The day of Intensive Care Unit (ICU) discharge

  4. SOFA score

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

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

  5. SOFA score

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

    Measured: The day of LVAD implantation

  6. SOFA score

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

    Measured: Day 1 post LVAD implantation

  7. SOFA score

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

    Measured: Day 3 post LVAD implantation

  8. SOFA score

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

    Measured: Day 5 post LVAD implantation

  9. SOFA score

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

    Measured: Day 7 post LVAD implantation

  10. Vital status

    mortality after LVAD implantation

    Measured: 1 month after LVAD implantation

  11. Vital status

    mortality after LVAD implantation

    Measured: 3 months after LVAD implantation

  12. Vital status

    mortality after LVAD implantation

    Measured: 6 months after LVAD implantation

  13. length of stay

    Intensive Care Unit length of stay

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

  14. length of stay

    hospital length of stay

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2020
  2. Study start20 Jan 2021
  3. Primary completion21 Apr 2021
  4. Study completion21 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04480151
Sponsor's protocol ID
CHUBX 2020/37
Acronym
ECI-BLAD
Status last verified
Jul 2021
First submitted
13 Jul 2020
Last updated
7 Jul 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiogenic Shock and End-stage Heart Failure, run by University Hospital, Bordeaux at 5 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04480151.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2021.

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