ECMELLA vs. ECMO on 30-day Mortality

• Conditions: Extracorporeal Membrane Oxygenation Complication; Cardiogenic Shock; Acute Myocardial Infarction; Cardiac Arrest; Cardiopulmonary Arrest
• Interventions: Device: VA-ECMO; Device: ECMELLA

• Registration Number: NCT05175898
• Lead Sponsor: Charite University, Berlin, Germany

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.

Study Timeline

• Study First Submitted: 2021-10-27
• Status Verified: 2021-12
• Study First Submitted QC: 2021-12-14
• Last Update Submitted: 2021-12-14
• Study First Posted: 2022-01-04
• Last Update Posted: 2022-01-04
• Study Start: 2022-02
• Primary Completion: 2022-10
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
VA-ECMO	VA-ECMO	Patients who were treated with veno-arterial extracorporeal membrane oxygenation (VA-ECMO) during cardiac arrest.
ECMELLA	ECMELLA	Patients who were treated with veno-arterial extracorporeal membrane oxygenation (VA-ECMO) and Impella® micro-axial pump.

Primary Outcome Measures

Name	Time	Method
30-day mortality	Mortality within 30 days after cardiac arrest event.	Mortality within 30 days after cardiac arrest event.

Secondary Outcome Measures

Name	Time	Method
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.
Hospital length of stay	Through study completion - an average of 1 year.	Number of days between hospital admission and hospital discharge.

Trial Locations

Locations (1)

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany