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

July 6, 2021 updated by: University Hospital, Bordeaux

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
92

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21079
        • CHU de Dijon-Bourgoigne
      • Montpellier, France, 34295
        • CHU de Montpellier
      • Pessac, France, 33604
        • CHU de Bordeaux
      • Rennes, France, 35000
        • CHU de Rennes
      • Toulouse, France, 31059
        • CHU de Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
IMPELLA™ alone as bridge to LVAD
patients 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)
Other: standard of care
retrospective study: standard of care
ECLS alone or with IMPELLA™ as bridge to LVAD
patients assisted by ECLS (ExtraCorporeal life support) alone or simultaneously with IMPELLA™ until the implantation of LVAD
Other: standard of care
retrospective study: standard of care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Day 30 after Left Ventricular Assist Device (LVAD) implantation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
The day of Left Ventricular Assist Device (LVAD) implantation
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]
The day before LVAD implantation
complication Under LVAD
Time Frame: The day of Intensive Care Unit (ICU) discharge
bleeding, right ventricular dysfunction, vasoplegia
The day of Intensive Care Unit (ICU) discharge
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]
The day of Short Term Mechanical Circulatory Support (STMCS) implantation
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]
The day of LVAD implantation
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]
Day 1 post LVAD implantation
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]
Day 3 post LVAD implantation
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]
Day 5 post LVAD implantation
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]
Day 7 post LVAD implantation
Vital status
Time Frame: 1 month after LVAD implantation
mortality after LVAD implantation
1 month after LVAD implantation
Vital status
Time Frame: 3 months after LVAD implantation
mortality after LVAD implantation
3 months after LVAD implantation
Vital status
Time Frame: 6 months after LVAD implantation
mortality after LVAD implantation
6 months after LVAD implantation
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
up to Intensive Care Unit (ICU) discharge (not more than 6 months after LVAD implantation)
length of stay
Time Frame: up to hospital discharge (not more than 6 months after LVAD implantation)
hospital length of stay
up to hospital discharge (not more than 6 months after LVAD implantation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 20, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 21, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 21, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 7, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHUBX 2020/37

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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