Cardiac ArrestNCT05175898
ECMELLA vs. ECMO on 30-day Mortality
An observational study of Cardiac Arrest and Cardiopulmonary Arrest, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
This international, multicenter cohort study aims to investigate outcomes after treatment with extracorporeal cardiopulmonary resuscitation (eCPR) during cardiac arrest. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest, Cardiopulmonary Arrest, Extracorporeal Membrane Oxygenation Complication
- What is being tested?
- VA-ECMO and ECMELLA
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2022to Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- 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)
Who cannot join
- Non-adult patients
- No treatment with VA-ECMO or "ECMELLA"
Trial locations and contacts
1 site in 1 country.
About this study
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
This international, multicenter cohort study aims to investigate outcomes after treatment with extracorporeal cardiopulmonary resuscitation (eCPR) during cardiac arrest.
Read the 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.
- Conditions
- Cardiac Arrest, Cardiopulmonary Arrest, Extracorporeal Membrane Oxygenation Complication, Cardiogenic Shock, Acute Myocardial Infarction
- Being tested
- VA-ECMO, ECMELLA
- Medical subject headings
- Heart Arrest, Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VA-ECMODevice
Treatment with veno-arterial extracorporeal membrane oxygenation
ECMELLADevice
Treatment with veno-arterial extracorporeal membrane oxygenation plus Impella® micro-axial pump.
| Study group | Role | What they receive |
|---|---|---|
| VA-ECMO | Patients who were treated with veno-arterial extracorporeal membrane oxygenation (VA-ECMO) during cardiac arrest. Receives: Device: VA-ECMO | |
| ECMELLA | Patients who were treated with veno-arterial extracorporeal membrane oxygenation (VA-ECMO) and Impella® micro-axial pump. Receives: Device: ECMELLA |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day mortality
Mortality within 30 days after cardiac arrest event.
Measured: Mortality within 30 days after cardiac arrest event.
Secondary outcomes (2)
Hospital length of stay
Number of days between hospital admission and hospital discharge.
Measured: 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.
Measured: Through study completion - an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study startFeb 2022 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carsten Skurk, Charite University, Berlin, Germany
- Investigators
- Carsten Skurk, MD, Principal investigator, Charite UniversityTharusan Thevathasan, MD, Principal investigator, Charite University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05175898
- Sponsor's protocol ID
- ECMELLA vs. ECMO
- Status last verified
- Dec 2021
- First submitted
- 27 Oct 2021
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05175898
- Acronym / sponsor ID
- ECMELLA vs. ECMO
- Conditions
- Cardiac Arrest, Cardiopulmonary Arrest, Extracorporeal Membrane Oxygenation Complication, Cardiogenic Shock, Acute Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Feb 2022 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 4 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VA-ECMO | – | Device: VA-ECMOPatients who were treated with veno-arterial extracorporeal membrane oxygenation (VA-ECMO) during cardiac arrest. |
| ECMELLA | – | Device: ECMELLAPatients who were treated with veno-arterial extracorporeal membrane oxygenation (VA-ECMO) and Impella® micro-axial pump. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- Non-adult patients
- No treatment with VA-ECMO or "ECMELLA"
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VA-ECMOTreatment with veno-arterial extracorporeal membrane oxygenation | Device | VA-ECMO |
| ECMELLATreatment with veno-arterial extracorporeal membrane oxygenation plus Impella® micro-axial pump. | Device | ECMELLA |
Primary outcome
30-day mortality
Time frame: Mortality within 30 days after cardiac arrest event.
Mortality within 30 days after cardiac arrest event.
2 secondary outcomes
Hospital length of stay
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Individual participant dataSharing planned: No
Related trials for Cardiac Arrest
RecruitingObservational study
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
RecruitingObservational study
Accuracy of Doppler Ultrasound Versus Manual Palpation of Pulse in Cardiac Arrest
Cardiac Arrest
Active, not recruiting
RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems
Cardiac Arrest
Not yet recruiting
Generative AI and Gamified Simulation-Based Train-the-Trainer Basic Life Support Training for High School Teachers in Vietnam
Cardiac Arrest, Cardiopulmonary Resuscitation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carsten Skurk, MD principal investigator
Charite University
Tharusan Thevathasan, MD principal investigator
Charite University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest and Cardiopulmonary Arrest, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day mortality (time frame: Mortality within 30 days after cardiac arrest event.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2022.