ECMELLA vs. ECMO on 30-day Mortality

December 14, 2021 updated by: Carsten Skurk, Charite University, Berlin, Germany

Treatment With Leftventricular Impella® Micro-axial Pump and Veno-Arterial Extracorporeal Membrane Oxygenation (VA-ECMO) During Extracorporeal Cardiopulmonary Resuscitation (eCPR) on Mortality - An International Multicenter Cohort Study

This international, multicenter cohort study aims to investigate outcomes after treatment with extracorporeal cardiopulmonary resuscitation (eCPR) during cardiac arrest.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Left ventricular unloading with Impella® micro-axial pump has been shown to improve survival in patients with cardiogenic shock treated with veno-arterial extracorporeal membrane oxygenation (VA-ECMO). This study aims to investigate whether treatment with VA-ECMO and Impella ® (so called "ECMELLA") during extracorporeal cardiopulmonary resuscitation is associated with improved outcomes.

Study Type

Observational

Enrollment (Anticipated)

60

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

  • Germany
      • Berlin, Germany, 12203
        • Charité - Universitätsmedizin Berlin

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

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

Adult patients who were treated with veno-arterial extracorporeal membrane oxygenation (VA-ECMO) or VA-ECMO and Impella (so called "ECMELLA") during extracorporeal cardiopulmonary resuscitation.

Description

Inclusion Criteria:

  • Adult patients
  • Cardiac arrest
  • Treatment with veno-arterial extracorporeal membrane oxygenation (VA-ECMO) or "ECMELLA" (that is VA-ECMO plus left ventricular Impella® micro-axial pump)

Exclusion Criteria:

  • Non-adult patients
  • No treatment with VA-ECMO or "ECMELLA"

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
Intervention / Treatment
VA-ECMO
Patients who were treated with veno-arterial extracorporeal membrane oxygenation (VA-ECMO) during cardiac arrest.
Device: VA-ECMO
Treatment with veno-arterial extracorporeal membrane oxygenation
ECMELLA
Patients who were treated with veno-arterial extracorporeal membrane oxygenation (VA-ECMO) and Impella® micro-axial pump.
Device: ECMELLA
Treatment with veno-arterial extracorporeal membrane oxygenation plus Impella® micro-axial pump.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-day mortality
Time Frame: Mortality within 30 days after cardiac arrest event.
Mortality within 30 days after cardiac arrest event.
Mortality within 30 days after cardiac arrest event.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital length of stay
Time Frame: Through study completion - an average of 1 year.
Number of days between hospital admission and hospital discharge.
Through study completion - an average of 1 year.
Intensive Care Unit (ICU) length of stay
Time Frame: Through study completion - an average of 1 year.
Number of ICU days between ICU admission and ICU discharge.
Through study completion - an average of 1 year.

Collaborators and Investigators

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

Sponsor

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Carsten Skurk, MD, Charite University
  • Principal Investigator: Tharusan Thevathasan, MD, Charite University

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 (Anticipated)

February 1, 2022

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

November 1, 2022

Study Registration Dates

First Submitted

October 27, 2021

First Submitted That Met QC Criteria

December 14, 2021

First Posted (Actual)

January 4, 2022

Study Record Updates

Last Update Posted (Actual)

January 4, 2022

Last Update Submitted That Met QC Criteria

December 14, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECMELLA vs. ECMO

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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