ECMELLA vs. ECMO on 30-day Mortality | NCT05175898

Studies
ECMELLA vs. ECMO on 30-day Mortality

NCT05175898

Sponsor

Charite University, Berlin, Germany

Status

Unknown status

Last Update Posted

Jan 4, 2022Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Cardiac Arrest
Cardiopulmonary Arrest
Extracorporeal Membrane Oxygenation Complication
Cardiogenic Shock
Acute Myocardial Infarction

Interventions

VA-ECMO
ECMELLA

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2022Estimated

Primary Completion Date

Oct 2022Estimated

Completion Date

Nov 2022Estimated

First Submitted Date

Oct 27, 2021

First Submission Date that Met QC Criteria

Dec 14, 2021

First Posted Date

Jan 4, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 14, 2021

Last Update Posted Date

Jan 4, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Carsten Skurk, Professor, Charite University, Berlin, GermanyPrincipal Investigator

Lead Sponsor

Charite University, Berlin, GermanyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
VA-ECMO	Device	Treatment with veno-arterial extracorporeal membrane oxygenation	VA-ECMO

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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"

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carsten Skurk, MD	Charite University	Principal Investigator
Tharusan Thevathasan, MD	Charite University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charité - Universitätsmedizin Berlin		Berlin		12203	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006323	Heart Arrest
D012770	Shock, Cardiogenic

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D009203	Myocardial Infarction
D017202	Myocardial Ischemia

Browse Leaves

Not provided

Browse Branches

Not provided