Out-Of-Hospital Cardiac ArrestRESuSCITATeNCT03658759
Rapid Response VA-ECMO in Refractory Out-of-hospital Cardiac Arrest
An observational study of Out-Of-Hospital Cardiac Arrest, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
A selected group of patients with refractory cardiac arrest may benefit from inhospital treatment and this may warrant transfer to the hospital with ongoing CPR. In patients with VF or ventricular tachycardia (VT) the underlying cause may be reversible and damage to other organs is limited at the time of the arrest. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Out-Of-Hospital Cardiac Arrest
- What is being tested?
- Extracorporeal Cardiopulmonary Resuscitation
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 Jul 2018to 2 Jul 2020
- How long will I take part?
- 6 Months
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with refractory OHCA due to VF/VT, witnessed cardiac arrest and basic life support before EMS arrival.
Who may be able to join
- Witnessed arrest
- Bystander CPR initiated before EMS arrival or EMS-witnessed arrest
- VF/VT as first recorded rhythm by EMS or shock delivered by AED
- No ROSC within 10 minutes after EMS arrival
- Ambulance transport with mechanical chest compression device
Who cannot join
- Confirmation of ROSC
- End-tidal CO2 < 10 mmHg
- Known terminal disease (eg. cancer)
- Known severe comorbidity
- Severe chronic pulmonary disease (GOLD classification 3 or 4)
- Heart failure NYHA classification 3 or 4
Show all 9Show fewer
- Known history of bifemoral surgery
- Do Not Resuscitate (DNR) order
- Expected time from transport decision to start ECMO >60 minute
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Academic Medical Center
Amsterdam, North Holland, 1105AZ
About this study
Official title: ECPR Treatment Protocol: Rapid Response VA-ECMO in Refractory Out-of-hospital Cardiac Arrest (RESuSCITATe Registry)
A selected group of patients with refractory cardiac arrest may benefit from inhospital treatment and this may warrant transfer to the hospital with ongoing CPR. In patients with VF or ventricular tachycardia (VT) the underlying cause may be reversible and damage to other organs is limited at the time of the arrest. Many patients will have a coronary event that can be treated by angioplasty. However, up to now absence of ROSC poses a barrier for angioplasty, and most patients are therefore not even transported to a hospital. With the use of extra corporeal membrane oxygenation (ECMO) the circulation can be restored immediately, providing time to diagnose and treat the underlying cause of the cardiac arrest. International cohort studies show that a strategy of pre-hospital triage and transport to a cardiac arrest expertise center for "rapid-response" ECMO and coronary revascularization is feasible and improves survival.
A clinical pathway will encompass intense cooperation and optimal logistics between several paramedical and medical disciplines, i.e. from prehospital ambulance service to intensive care. Incorporation of mechanical chest compressions devices (LUCAS™), rapid-response veno-arterial (VA-)ECMO (Cardiohelp, Maquet), and ECMO assisted revascularization in a dedicated clinical pathway will offer a potential lifesaving treatment option that is in accordance with the recommendations in the current Guidelines.
The aim of the study is to investigate the feasibility of a new local clinical pathway in our hospital to provide ECPR for refractory OHCA patients.
Read the detailed description
Coronary heart disease is the leading cause of cardiac arrest. The incidence of cardiac arrest in Europe is between 0.4 and 1 per 1000 inhabitants per year, thus involving between 350.000 and 700.000 people per year. Approximately, 275.000 of these cardiac arrests are treated by the emergency medical service (EMS) in Europe. (1) Survival after cardiac arrest varies from less than 5% to 60% according to the characteristics of the cardiac arrest event (e.g. cardiac etiology, witnessed arrest, initial recorded rhythm (shockable: ventricular fibrillation (VF), ventricular tachycardia (VT) or not shockable).(1) Cardiac arrest patients, who despite conventional cardiopulmonary resuscitation (CPR) do not achieve return of spontaneous circulation (ROSC) within 10-20 minutes of advanced life support (ALS) have the worst prognosis with rates of survival to hospital discharge of 2-11%.
A selected group of patients with refractory cardiac arrest may benefit from very aggressive in-hospital treatment and this may warrant transfer to the hospital with ongoing CPR. In patients with VF or ventricular tachycardia (VT) the underlying cause may be reversible and damage to other organs is limited at the time of the arrest. Many patients will have a coronary event that can be treated by angioplasty. However, up to now absence of ROSC poses a barrier for angioplasty, and most patients are therefore not even transported to a hospital.
With the use of extra corporeal membrane oxygenation (ECMO) the circulation can be restored immediately, providing time to diagnose and treat the underlying cause of the cardiac arrest. International cohort studies show that a strategy of pre-hospital triage and transport to a cardiac arrest expertise center for "rapid-response" ECMO and coronary revascularization is feasible and improves survival. The recent 2015 European Resuscitation Council Guidelines for Resuscitation position extracorporeal CPR (ECPR) as follows: "ECPR should be considered as a rescue therapy for those patients in whom initial advanced life support (ALS) measures are unsuccessful and to facilitate specific interventions (e.g. coronary angiography and percutaneous coronary intervention (PCI) or pulmonary thrombectomy for massive pulmonary embolism)".(2) A recent meta-analysis performed by our group supports ECMO in this setting. (3)
Currently, a strong pre-hospital and clinical pathway for acute myocardial infarction exists in the greater Amsterdam region / Noord-Holland region, i.e. "Lifenet protocol". The Academic Medical Center is an international recognized center with the ARREST program to evaluate treatments for out-of-hospital cardiac arrest (OHCA).(4) However, a dedicated clinical pathway for refractory OHCA patients does not yet exist. Integration of the "Lifenet protocol" and ARREST program would provide an ideal setting to create and install a dedicated clinical pathway for these cardiac arrest patients.
The existing clinical pathway for cardiac arrest patients will be optimized and upgraded to be able to provide ECPR for refractory cardiac arrest patients. This clinical pathway will encompass intense cooperation and optimal logistics between several paramedical and medical disciplines, i.e. from pre-hospital ambulance service to intensive care. Incorporation of mechanical chest compressions devices (LUCAS™), rapid-response veno-arterial (VA-)ECMO (Cardiohelp, Maquet), and ECMO assisted revascularization in a dedicated clinical pathway will offer a potential lifesaving treatment option that is in accordance with the recommendations in the current Guidelines.
The aim of the study is to investigate the feasibility of a new local clinical pathway to provide ECPR for refractory OHCA patients.
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Being tested
- Extracorporeal Cardiopulmonary Resuscitation
- Keywords
- Extra corporeal Life support, extracorporeal cardiopulmonary resuscitation, refractory out-of-hospital cardiac arrest, extra corporeal membrane oxygenation, mechanical circulatory support, mechanical chest compressions
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Cardiopulmonary ResuscitationProcedure or surgery
Also called Extra Corporeal Life support, Extra Corporeal Membrane Oxygenation, Mechanical chest compressions
local ECPR clinical pathway, including transport with mechanical chest compression device and rapid response VA-ECMO
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year mortality
Measured: assessed through study completion: at 1-year.
Secondary outcomes (10)
Adverse outcomes
Major adverse cardiac events (MACE) (death, myocardial infarction, revascularization, stent thrombosis, stroke, bleeding)
- CPR-related complications (chest wall compartment syndrome, pneumothorax, chylothorax, pulmonary hemorrhage)
- ECMO-related complications (bleeding requiring transfusion or surgery, stroke, sepsis, limb ischemia requiring intervention, system or cannula change)
- Other complications (acute renal failure, ulcer bleeding, pneumonia, sepsis)
Measured: assessed through study completion: for the time in the hospital , at 30-days and at 1-year.
Other clinical endpoints: Mortality rate - patients not treated with ECPR in comparison to patients treated with ECPR
Mortality rate of patients treated with ECPR in comparison to refractory OHCA patients treated outside of the hours in which ECPR can take place
Measured: assessed through study completion: at 30-days, at 1-year after inclusion of patient
Percentage of successful cannulations
Measured: assessed through study completion: at 1 year and at the end of study inclusion period (expected to be at 1.5 years)
Neurological outcome at 6 months on the cerebral performance category scale (CPC)
measured with CPC scale: CPC 1A return to normal cerebral function and normal living CPC 2 Cerebral disability but sufficient function for independent activities of daily living CPC 3 Severe disability, limited cognition, inability to carry out independent existence CPC 4 Coma CPC 5 Brain death
Measured: assessed through study completion: at 6 months after inclusion of patient.
Quality of life at 6 months assessed by Short form 36 (SF-36)
measured with quality of life assesment form Short form 36 (SF-36). The SF-36 comprises 36 items and contains eight subscales: physical functioning, social functioning, physical role functioning, emotional role functioning, mental health, vitality, bodily pain and general health. Scores are expressed on a scale of 0-100, higher values indicate better quality of life and wellbeing.
Measured: assessed through study completion: at 6 months after inclusion of patient.
Rate of eligible / ineligible patients treated with ECPR
How many patients that were treated with ECPR were retrospectively eligible for treatment with ECPR, in comparison to how many patients were treated, but not eligible.
Measured: assessed through study completion: at 1 year and at the end of study inclusion period (expected to be at 1.5 years)
Noted reasons for non-adherence to the eligibility criteria ECPR
If patients were treated with ECPR, but were not eligible, what were reasons to do so? (for instance: no knowledge beforehand of ineligibility, or, knowledge beforehand of ineligibility but expert decision to treat, etc.)
Measured: assessed through study completion: at 1 year and at the end of study inclusion period (expected to be at 1.5 years)
Number of patients with complete data collection
Measured: assessed through study completion: at 1 year and at the end of study inclusion period (expected to be at 1.5 years)
Rate of eligible / ineligible patients not treated with ECPR
How many patients that were not treated with ECPR were retrospectively eligible for treatment with ECPR, in comparison to how many patients were not treated, and not eligible.
Measured: assessed through study completion: at 1 year and at the end of study inclusion period (expected to be at 1.5 years)
30-days mortality
Measured: assessed through study completion: at 30-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start2 Jul 2018
- Primary completion2 Dec 2019 (estimated)
- Study completion2 Jul 2020 (estimated)
Why it stopped: Study cancelled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Out-Of-Hospital Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J.P.S Henriques, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Jose P.S. Henriques, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03658759
- Sponsor's protocol ID
- ECPR-062018-UAMC
- Acronym
- RESuSCITATe
- Status last verified
- Feb 2022
- First submitted
- 27 Jun 2018
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ECPR Treatment Protocol: Rapid Response VA-ECMO in Refractory Out-of-hospital Cardiac Arrest (RESuSCITATe Registry)
- ClinicalTrials.gov ID
- NCT03658759
- Acronym / sponsor ID
- RESuSCITATe / ECPR-062018-UAMC
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Keywords
- Extra corporeal Life support, extracorporeal cardiopulmonary resuscitation, refractory out-of-hospital cardiac arrest, extra corporeal membrane oxygenation, mechanical circulatory support, mechanical chest compressions
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study cancelled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- 2 Dec 2019 (estimated)
- Study completion
- 2 Jul 2020 (estimated)
- First posted
- 5 Sep 2018 (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.
A selected group of patients with refractory cardiac arrest may benefit from inhospital treatment and this may warrant transfer to the hospital with ongoing CPR. In patients with VF or ventricular tachycardia (VT) the underlying cause may be reversible and damage to other organs is limited at the time of the arrest. Many patients will have a coronary event that can be treated by angioplasty. However, up to now absence of ROSC poses a barrier for angioplasty, and most patients are therefore not even transported to a hospital. With the use of extra corporeal membrane oxygenation (ECMO) the circulation can be restored immediately, providing time to diagnose and treat the underlying cause of the cardiac arrest. International cohort studies show that a strategy of pre-hospital triage and transport to a cardiac arrest expertise center for "rapid-response" ECMO and coronary revascularization is feasible and improves survival.
A clinical pathway will encompass intense cooperation and optimal logistics between several paramedical and medical disciplines, i.e. from prehospital ambulance service to intensive care. Incorporation of mechanical chest compressions devices (LUCAS™), rapid-response veno-arterial (VA-)ECMO (Cardiohelp, Maquet), and ECMO assisted revascularization in a dedicated clinical pathway will offer a potential lifesaving treatment option that is in accordance with the recommendations in the current Guidelines.
The aim of the study is to investigate the feasibility of a new local clinical pathway in our hospital to provide ECPR for refractory OHCA patients.
Detailed description
Coronary heart disease is the leading cause of cardiac arrest. The incidence of cardiac arrest in Europe is between 0.4 and 1 per 1000 inhabitants per year, thus involving between 350.000 and 700.000 people per year. Approximately, 275.000 of these cardiac arrests are treated by the emergency medical service (EMS) in Europe. (1) Survival after cardiac arrest varies from less than 5% to 60% according to the characteristics of the cardiac arrest event (e.g. cardiac etiology, witnessed arrest, initial recorded rhythm (shockable: ventricular fibrillation (VF), ventricular tachycardia (VT) or not shockable).(1) Cardiac arrest patients, who despite conventional cardiopulmonary resuscitation (CPR) do not achieve return of spontaneous circulation (ROSC) within 10-20 minutes of advanced life support (ALS) have the worst prognosis with rates of survival to hospital discharge of 2-11%.
A selected group of patients with refractory cardiac arrest may benefit from very aggressive in-hospital treatment and this may warrant transfer to the hospital with ongoing CPR. In patients with VF or ventricular tachycardia (VT) the underlying cause may be reversible and damage to other organs is limited at the time of the arrest. Many patients will have a coronary event that can be treated by angioplasty. However, up to now absence of ROSC poses a barrier for angioplasty, and most patients are therefore not even transported to a hospital.
With the use of extra corporeal membrane oxygenation (ECMO) the circulation can be restored immediately, providing time to diagnose and treat the underlying cause of the cardiac arrest. International cohort studies show that a strategy of pre-hospital triage and transport to a cardiac arrest expertise center for "rapid-response" ECMO and coronary revascularization is feasible and improves survival. The recent 2015 European Resuscitation Council Guidelines for Resuscitation position extracorporeal CPR (ECPR) as follows: "ECPR should be considered as a rescue therapy for those patients in whom initial advanced life support (ALS) measures are unsuccessful and to facilitate specific interventions (e.g. coronary angiography and percutaneous coronary intervention (PCI) or pulmonary thrombectomy for massive pulmonary embolism)".(2) A recent meta-analysis performed by our group supports ECMO in this setting. (3)
Currently, a strong pre-hospital and clinical pathway for acute myocardial infarction exists in the greater Amsterdam region / Noord-Holland region, i.e. "Lifenet protocol". The Academic Medical Center is an international recognized center with the ARREST program to evaluate treatments for out-of-hospital cardiac arrest (OHCA).(4) However, a dedicated clinical pathway for refractory OHCA patients does not yet exist. Integration of the "Lifenet protocol" and ARREST program would provide an ideal setting to create and install a dedicated clinical pathway for these cardiac arrest patients.
The existing clinical pathway for cardiac arrest patients will be optimized and upgraded to be able to provide ECPR for refractory cardiac arrest patients. This clinical pathway will encompass intense cooperation and optimal logistics between several paramedical and medical disciplines, i.e. from pre-hospital ambulance service to intensive care. Incorporation of mechanical chest compressions devices (LUCAS™), rapid-response veno-arterial (VA-)ECMO (Cardiohelp, Maquet), and ECMO assisted revascularization in a dedicated clinical pathway will offer a potential lifesaving treatment option that is in accordance with the recommendations in the current Guidelines.
The aim of the study is to investigate the feasibility of a new local clinical pathway to provide ECPR for refractory OHCA patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with refractory OHCA due to VF/VT, witnessed cardiac arrest and basic life support before EMS arrival.
Key inclusion criteria (5 listed)
- Witnessed arrest
- Bystander CPR initiated before EMS arrival or EMS-witnessed arrest
- VF/VT as first recorded rhythm by EMS or shock delivered by AED
- No ROSC within 10 minutes after EMS arrival
- Ambulance transport with mechanical chest compression device
Key exclusion criteria (9 listed)
- Confirmation of ROSC
- End-tidal CO2 < 10 mmHg
- Known terminal disease (eg. cancer)
- Known severe comorbidity
- Do Not Resuscitate (DNR) order
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 |
|---|---|---|
| Extracorporeal Cardiopulmonary ResuscitationAlso: Extra Corporeal Life support, Extra Corporeal Membrane Oxygenation, Mechanical chest compressionslocal ECPR clinical pathway, including transport with mechanical chest compression device and rapid response VA-ECMO | Procedure or surgery | – |
Primary outcome
1-year mortality
Time frame: assessed through study completion: at 1-year.
10 secondary outcomes
Adverse outcomes
Time frame: assessed through study completion: for the time in the hospital , at 30-days and at 1-year.
Other clinical endpoints: Mortality rate - patients not treated with ECPR in comparison to patients treated with ECPR
Time frame: assessed through study completion: at 30-days, at 1-year after inclusion of patient
Percentage of successful cannulations
Time frame: assessed through study completion: at 1 year and at the end of study inclusion period (expected to be at 1.5 years)
Neurological outcome at 6 months on the cerebral performance category scale (CPC)
Time frame: assessed through study completion: at 6 months after inclusion of patient.
Quality of life at 6 months assessed by Short form 36 (SF-36)
Time frame: assessed through study completion: at 6 months after inclusion of patient.
Rate of eligible / ineligible patients treated with ECPR
Time frame: assessed through study completion: at 1 year and at the end of study inclusion period (expected to be at 1.5 years)
Noted reasons for non-adherence to the eligibility criteria ECPR
Time frame: assessed through study completion: at 1 year and at the end of study inclusion period (expected to be at 1.5 years)
Number of patients with complete data collection
Time frame: assessed through study completion: at 1 year and at the end of study inclusion period (expected to be at 1.5 years)
Rate of eligible / ineligible patients not treated with ECPR
Time frame: assessed through study completion: at 1 year and at the end of study inclusion period (expected to be at 1.5 years)
30-days mortality
Time frame: assessed through study completion: at 30-days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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.
Jose P.S. Henriques principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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 Out-Of-Hospital Cardiac Arrest, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 5 inclusion and 9 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: withdrawn, as of the sponsor's last update on 2 Mar 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 Netherlands. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
1-year mortality (time frame: assessed through study completion: at 1-year.). 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 2 Mar 2022.