NCT05175898

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 4, 2022

Completed
28 days until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

January 4, 2022

Status Verified

December 1, 2021

Enrollment Period

8 months

First QC Date

October 27, 2021

Last Update Submit

December 14, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 30-day mortality

    Mortality within 30 days after cardiac arrest event.

    Mortality within 30 days after cardiac arrest event.

Secondary Outcomes (2)

  • Hospital length of stay

    Through study completion - an average of 1 year.

  • Intensive Care Unit (ICU) length of stay

    Through study completion - an average of 1 year.

Study Arms (2)

VA-ECMO

Patients who were treated with veno-arterial extracorporeal membrane oxygenation (VA-ECMO) during cardiac arrest.

Device: VA-ECMO

ECMELLA

Patients who were treated with veno-arterial extracorporeal membrane oxygenation (VA-ECMO) and Impella® micro-axial pump.

Device: ECMELLA

Interventions

VA-ECMODEVICE

Treatment with veno-arterial extracorporeal membrane oxygenation

VA-ECMO
ECMELLADEVICE

Treatment with veno-arterial extracorporeal membrane oxygenation plus Impella® micro-axial pump.

ECMELLA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité - Universitätsmedizin Berlin

Berlin, 12203, Germany

Location

MeSH Terms

Conditions

Heart ArrestShock, Cardiogenic

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesMyocardial InfarctionMyocardial IschemiaVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShock

Study Officials

  • Carsten Skurk, MD

    Charite University

    PRINCIPAL INVESTIGATOR
  • Tharusan Thevathasan, MD

    Charite University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 27, 2021

First Posted

January 4, 2022

Study Start

February 1, 2022

Primary Completion

October 1, 2022

Study Completion

November 1, 2022

Last Updated

January 4, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations