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ECMELLA vs. ECMO on 30-day Mortality

Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05175898
Collaborator
(none)
60
Enrollment
1
Location
9
Anticipated Duration (Months)
6.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: VA-ECMO
  • Device: ECMELLA

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 Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
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
Anticipated Study Start Date :
Feb 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 30-day mortality [Mortality within 30 days after cardiac arrest event.]

    Mortality within 30 days after cardiac arrest event.

Secondary Outcome Measures

  1. Hospital length of stay [Through study completion - an average of 1 year.]

    Number of days between hospital admission and hospital discharge.

  2. Intensive Care Unit (ICU) length of stay [Through study completion - an average of 1 year.]

    Number of ICU days between ICU admission and ICU discharge.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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"

Contacts and Locations

Locations

Site City State Country Postal Code
1 Charité - Universitätsmedizin Berlin Berlin Germany 12203

Sponsors and Collaborators

  • Charite University, Berlin, Germany

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Carsten Skurk, Professor, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT05175898
Other Study ID Numbers:
  • ECMELLA vs. ECMO
First Posted:
Jan 4, 2022
Last Update Posted:
Jan 4, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Myocardial Infarction
Heart Arrest
Shock, Cardiogenic
Infarction

Study Results

No Results Posted as of Jan 4, 2022