Cardiac ArrestEROCANCT03065647
ECPR for Refractory Out-Of-Hospital Cardiac Arrest
A study testing Expedited Transport With Mechanical CPR in people with Cardiac Arrest and Heart Arrest, run by University of Michigan at 1 site in United States.
Trial summary
In the U.S. alone, over 300,000 people per year have sudden out-of-hospital cardiac arrest (OHCA), and less than 1 out of 10 survive. The current standard practice for treating OHCA is to perform cardiopulmonary resuscitation (CPR) and Advanced Cardiovascular Life Support (ACLS) at the scene until either the heart is… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cardiac Arrest, Heart Arrest, Sudden Cardiac Arrest
- What is being tested?
- Expedited Transport With Mechanical CPR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 5 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- OHCA of presumed non-traumatic etiology requiring CPR
- Predicted arrival time at ECPR-capable hospital within timeframe specified
- Witnessed arrest or initial shockable rhythm (VT or VF)
- Persistent cardiac arrest after initial cardiac rhythm analysis and shock (if shock is indicated)
Who cannot join
- Sustained return of spontaneous circulation (ROSC)
- Advanced directive indicating do not attempt resuscitation (DNAR) or do not intubate (DNI)
- Preexisting evidence of opting out of study
- Prisoner
- Pregnant (obvious or known)
- ECPR capable ED is not at the destination hospital as determined by EMS
- Legally authorized representative (LAR) or family member aware of study and refuses study participation at the scene
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Hospital
Ann Arbor, Michigan, 48109
About this study
Official title: Extracorporeal CPR for Refractory Out-of-Hospital Cardiac Arrest (EROCA)
In the U.S. alone, over 300,000 people per year have sudden out-of-hospital cardiac arrest (OHCA), and less than 1 out of 10 survive. The current standard practice for treating OHCA is to perform cardiopulmonary resuscitation (CPR) and Advanced Cardiovascular Life Support (ACLS) at the scene until either the heart is restarted or resuscitation efforts are considered hopeless and discontinued. An alternative strategy for those with refractory OHCA is expedited transport with ongoing mechanical CPR to an Emergency Department capable of performing extracorporeal cardiopulmonary resuscitation (ECPR). The purpose of study is to test if this strategy is feasible and beneficial.
Read the detailed description
Out-of-hospital sudden cardiac arrest (OHCA) is a life-threatening condition in which the heart suddenly stops beating and there is no blood flow to the body. If cardiac arrest is not treated immediately, it causes sudden death. In the U.S. alone, over 300,000 people per year have OHCA, and less than 1 out of 10 survive. Therefore, it is important to study new ways of treating cardiac arrest patients in order to improve survival.
The current standard practice for treating OHCA is to perform CPR and Advanced Cardiovascular Life Support (ACLS) at the scene until either the heart is restarted or resuscitation efforts are considered hopeless and discontinued. This practice is supported by the fact that all currently proven CPR therapies can be delivered by paramedics in the field.
However, promising new strategies have emerged that are more feasible to initiate in the hospital. One such strategy is extracorporeal cardiopulmonary resuscitation (ECPR). ECPR requires placement of catheters in large blood vessels and connected to a machine to take over the work of the heart and lungs.
This purpose of this study is to examine the feasibility and potential benefit of expedited transport with ongoing mechanical CPR for patients with refractory OHCA patients to an Emergency Department capable of initiating ECPR.
FDA approved this study as a staged feasibility study to enroll 15 participants and submit data prior to enrolling the second 15 participants. After enrolling 15 participants, the PI chose not to pursue an amendment to enroll additional participants due to slow accrual and research restrictions related to COVID.
- Conditions
- Cardiac Arrest, Heart Arrest, Sudden Cardiac Arrest, Cardiopulmonary Arrest, Death, Sudden, Cardiac, Cardiopulmonary Resuscitation
- Being tested
- Expedited Transport With Mechanical CPR
- Keywords
- Out-of-hospital cardiac arrest, Cardiac Arrest, Heart Arrest, Sudden Cardiac Arrest, Cardiopulmonary Resuscitation, Extracorporeal Cardiopulmonary Resuscitation, Extracorporeal Membrane Oxygenation, CPR, ECPR, ECMO, Emergency Medical Services, EMS, OHCA
- Medical subject headings
- Heart Arrest, Death, Sudden, Cardiac, Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expedited Transport With Mechanical CPRDevice
Patients with OHCA refractory to initial BLS and ACLS will be transported by EMS with ongoing mechanical CPR and ACLS to an emergency department capable of initiating ECPR.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | No intervention | Basic Life Support (BLS) and Advanced Cardiovascular Life Support (ACLS) by Emergency Medical Services (EMS) per existing EMS protocols at the scene of the cardiac arrest. |
| Expedited Transport | Experimental | Intervention: Expedited Transport with Mechanical CPR.
After initial Basic Life Support (BLS) and Advanced Cardiovascular Life Support (ACLS) by Emergency Medical Services (EMS) per existing EMS protocols, patients with refractory cardiac arrest are transported to an ECPR capable emergency department with ongoing mechanical CPR and ACLS for possible initiation of extracorporeal cardiopulmonary resuscitation (ECPR). Receives: Device: Expedited Transport With Mechanical CPR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergency Department Arrivals Under 30 Minutes
Proportion of patients with emergency department (ED) arrival less than or equal to 30 minutes from 911 call (or cardiac arrest onset if witnessed by EMS personnel).
Measured: Measured within one hour cardiac arrest onset
ECPR Initiations Under 30 Minutes
Proportion of ECPR eligible patients with ECPR flow initiated less than or equal to 30 minutes from ED arrival
Measured: Measured within 2 hours of cardiac arrest onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2017
- Study start1 May 2017
- Primary completion5 Mar 2020
- Study completion5 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Food and Drug Administration (FDA), Physio-Control
- Responsible party
- Principal investigator, Robert Neumar, University of Michigan
- Investigators
- Robert W Neumar, MD, PhD, Principal investigator, University of MichiganRobert H Bartlett, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03065647
- Sponsor's protocol ID
- HUM00117553
- Other IDs
- R34HL130738-01A1
- Acronym
- EROCA
- Status last verified
- May 2021
- First submitted
- 16 Feb 2017
- Last updated
- 3 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Hsu CH, Meurer WJ, Domeier R, Fowler J, Whitmore SP, Bassin BS, Gunnerson KJ, Haft JW, Lynch WR, Nallamothu BK, Havey RA, Kidwell KM, Stacey WC, Silbergleit R, Bartlett RH, Neumar RW. Extracorporeal Cardiopulmonary Resuscitation for Refractory Out-of-Hospital Cardiac Arrest (EROCA): Results of a Randomized Feasibility Trial of Expedited Out-of-Hospital Transport. Ann Emerg Med. 2021 Jul;78(1):92-101. doi: 10.1016/j.annemergmed.2020.11.011. Epub 2021 Feb 1.
PubMed 33541748
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracorporeal CPR for Refractory Out-of-Hospital Cardiac Arrest (EROCA)
- ClinicalTrials.gov ID
- NCT03065647
- Acronym / sponsor ID
- EROCA / HUM00117553
- Conditions
- Cardiac Arrest, Heart Arrest, Sudden Cardiac Arrest, Cardiopulmonary Arrest, Death, Sudden, Cardiac, Cardiopulmonary Resuscitation
- Keywords
- Out-of-hospital cardiac arrest, Cardiac Arrest, Heart Arrest, Sudden Cardiac Arrest, Cardiopulmonary Resuscitation, Extracorporeal Cardiopulmonary Resuscitation, Extracorporeal Membrane Oxygenation, CPR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Food and Drug Administration (FDA), Physio-Control
- Study start
- 1 May 2017 (actual)
- Primary completion
- 5 Mar 2020 (actual)
- Study completion
- 5 Mar 2020 (actual)
- First posted
- 28 Feb 2017 (actual)
- Results
- Posted 15 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the U.S. alone, over 300,000 people per year have sudden out-of-hospital cardiac arrest (OHCA), and less than 1 out of 10 survive. The current standard practice for treating OHCA is to perform cardiopulmonary resuscitation (CPR) and Advanced Cardiovascular Life Support (ACLS) at the scene until either the heart is restarted or resuscitation efforts are considered hopeless and discontinued. An alternative strategy for those with refractory OHCA is expedited transport with ongoing mechanical CPR to an Emergency Department capable of performing extracorporeal cardiopulmonary resuscitation (ECPR). The purpose of study is to test if this strategy is feasible and beneficial.
Detailed description
Out-of-hospital sudden cardiac arrest (OHCA) is a life-threatening condition in which the heart suddenly stops beating and there is no blood flow to the body. If cardiac arrest is not treated immediately, it causes sudden death. In the U.S. alone, over 300,000 people per year have OHCA, and less than 1 out of 10 survive. Therefore, it is important to study new ways of treating cardiac arrest patients in order to improve survival.
The current standard practice for treating OHCA is to perform CPR and Advanced Cardiovascular Life Support (ACLS) at the scene until either the heart is restarted or resuscitation efforts are considered hopeless and discontinued. This practice is supported by the fact that all currently proven CPR therapies can be delivered by paramedics in the field.
However, promising new strategies have emerged that are more feasible to initiate in the hospital. One such strategy is extracorporeal cardiopulmonary resuscitation (ECPR). ECPR requires placement of catheters in large blood vessels and connected to a machine to take over the work of the heart and lungs.
This purpose of this study is to examine the feasibility and potential benefit of expedited transport with ongoing mechanical CPR for patients with refractory OHCA patients to an Emergency Department capable of initiating ECPR.
FDA approved this study as a staged feasibility study to enroll 15 participants and submit data prior to enrolling the second 15 participants. After enrolling 15 participants, the PI chose not to pursue an amendment to enroll additional participants due to slow accrual and research restrictions related to COVID.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | –Basic Life Support (BLS) and Advanced Cardiovascular Life Support (ACLS) by Emergency Medical Services (EMS) per existing EMS protocols at the scene of the cardiac arrest. |
| Expedited Transport | Experimental | Device: Expedited Transport With Mechanical CPRIntervention: Expedited Transport with Mechanical CPR. After initial Basic Life Support (BLS) and Advanced Cardiovascular Life Support (ACLS) by Emergency Medical Services (EMS) per existing EMS protocols, patients with refractory cardiac arrest are transported to an ECPR capable emergency department with ongoing mechanical CPR and ACLS for possible initiation of extracorporeal cardiopulmonary resuscitation (ECPR). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- OHCA of presumed non-traumatic etiology requiring CPR
- Predicted arrival time at ECPR-capable hospital within timeframe specified
- Witnessed arrest or initial shockable rhythm (VT or VF)
- Persistent cardiac arrest after initial cardiac rhythm analysis and shock (if shock is indicated)
Key exclusion criteria (7 listed)
- Sustained return of spontaneous circulation (ROSC)
- Advanced directive indicating do not attempt resuscitation (DNAR) or do not intubate (DNI)
- Preexisting evidence of opting out of study
- Prisoner
- Pregnant (obvious or known)
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 |
|---|---|---|
| Expedited Transport With Mechanical CPRPatients with OHCA refractory to initial BLS and ACLS will be transported by EMS with ongoing mechanical CPR and ACLS to an emergency department capable of initiating ECPR. | Device | Expedited Transport |
Primary outcome
Emergency Department Arrivals Under 30 Minutes
Time frame: Measured within one hour cardiac arrest onset
Proportion of patients with emergency department (ED) arrival less than or equal to 30 minutes from 911 call (or cardiac arrest onset if witnessed by EMS personnel).
ECPR Initiations Under 30 Minutes
Time frame: Measured within 2 hours of cardiac arrest onset
Proportion of ECPR eligible patients with ECPR flow initiated less than or equal to 30 minutes from ED arrival
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33541748Hsu CH, Meurer WJ, Domeier R, Fowler J, Whitmore SP, Bassin BS, Gunnerson KJ, Haft JW, Lynch WR, Nallamothu BK, Havey RA, Kidwell KM, Stacey WC, Silbergleit R, Bartlett RH, Neumar RW. Extracorporeal Cardiopulmonary Resuscitation for Refractory Out-of-Hospital Cardiac Arrest (EROCA): Results of a Randomized Feasibility Trial of Expedited Out-of-Hospital Transport. Ann Emerg Med. 2021 Jul;78(1):92-101. doi: 10.1016/j.annemergmed.2020.11.011. Epub 2021 Feb 1.
- EROCA Study WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Robert W Neumar, MD, PhD principal investigator
University of Michigan
Robert H Bartlett, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expedited Transport With Mechanical CPR in people with Cardiac Arrest and Heart Arrest, run by University of Michigan at 1 site in United States.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 3 Jun 2021. 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 United States. 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?
Yes. Results are posted in the registry (first posted 15 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Emergency Department Arrivals Under 30 Minutes (time frame: Measured within one hour cardiac arrest onset). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03065647, which also lists 1 linked publication.
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 3 Jun 2021.