Out of Hospital Cardiac ArrestPACERNCT06177730
Pre-hospital ECMO or Conventional Resuscitation for Refractory Cardiac Arrest
A study testing Pre-Hospital ECPR in people with Out of Hospital Cardiac Arrest, run by Australian and New Zealand Intensive Care Research Centre.
Trial summary
This pilot study aims to determine feasibility of randomising patients to receive pre-hospital Extracorporeal Cardiopulmonary Resuscitation (ECPR) compared to conventional cardiac arrest care for refractory out of hospital cardiac arrest (OHCA). 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?
- Pre-Hospital ECPR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Dec 2024
- Phase
- Interventional
- 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
Who may be able to join
- Adult patients 18-70 years old
- Witnessed cardiac arrest
- Bystander CPR
- Refractory cardiac arrest (>20 mins, but <45 mins)
- Initial cardiac rhythm VF, VT or PEA
- Within hours of PACER service operation (e.g. mon-fri 0800-1700)
- Within 25 mins of rapid response ambulance (code 1 lights and sirens)
Who cannot join
- Initial cardiac rhythm asystole
- ROSC with sustained recovery
- Technically not possible to perform percutaneous cannulation
- Evidence of/suspectedSignificant end stage disease:
- Severe disability impairing activities of daily living
- End-stage organ - cardiac, liver, lung, renal
- Other life-limiting diseases e.g malignancy, terminal illness
- Advance health care directive (not for resuscitation)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: PACER:Pre-hospital ECMO or Conventional Resuscitation for Refractory Cardiac Arrest. An Investigator Initiated, Parallel Group, Assessor-blinded, Registry Embedded, Randomised Controlled Pilot Trial
This pilot study aims to determine feasibility of randomising patients to receive pre-hospital Extracorporeal Cardiopulmonary Resuscitation (ECPR) compared to conventional cardiac arrest care for refractory out of hospital cardiac arrest (OHCA).
The success of this study will be measured by the number of patients recruited into the study successfully treated with the treatment they were randomised to receive in the pre-Hospital setting.
Read the detailed description
Conventional cardiac arrest care, including high performance cardiopulmonary resuscitation, defibrillation and administration of drugs such as adrenaline is the current treatment for out of hospital cardiac arrest. In cases where this treatment does not see spontaneous circulation restored promptly, the patients cardiac arrest is termed refractory. Refractory Cardiac arrest is coupled with an increased risk of hypoxic injury to vital organs and the prospect of survival with good neurological recovery decreases dramatically.
ECPR is an effective way to restore circulation for patients with refractory OHCA. Hospital based ECPR is the most common process by which refractory OHCA patients are treated with ECPR. Patients are transported to an ECPR capable hospital while receiving mechanical CPR. Transporting patients while receiving mechanical CPR is challenging and may lead to less effective CPR (low flow). It may also delay access to urgent hospital based treatments due to the extra time required to load a patient receiving mechanical CPR.
Pre-Hospital ECPR is where the ECMO team rapidly attends the scene and implements ECMO while CPR is on-going at the scene. Benefits of this approach may include reduced low-flow time due to both earlier ECMO initiation as well as allowing the emergency responders focus on delivering high performance CPR rather than loading the patient for transport.
The results of this study will inform a larger study where researchers will compare these two treatments to determine if ECPR leads to higher survival rates and better recovery for patients with refractory OHCA. Observational data for pre-hospital ECPR in the Australian setting looks promising. However ECPR systems are expensive and resource intensive, making answering this question an imperative.
- Conditions
- Out of Hospital Cardiac Arrest
- Being tested
- Pre-Hospital ECPR
- Keywords
- ECMO, OHCA, pre-hospital, Extracorporeal Membrane Oxygenation, Out of Hospital Cardiac Arrest, ECPR, Extracorproreal Membrane Oxygenation
- 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.
Pre-Hospital ECPROther
Implementation of pre-Hospital ECPr in OHCA
| Study group | Role | What they receive |
|---|---|---|
| Pre-hospital ECPR Strategy | Active comparator | All patients will have high performance CPR at the scene throughout the resuscitation. If the patient is randomised to the Pre-hospital ECPR Strategy, this will be continued until the PACER team arrives. If return of spontaneous circulation (ROSC) has not been achieved at this point, ECPR will be implemented. The patient will be transported to The Alfred Hospital to receive ongoing care. Receives: Other: Pre-Hospital ECPR |
| Conventional Cardiac Arrest Strategy | No intervention | All patients will have high performance CPR at the scene throughout the resuscitation. If the patient has been randomised to the Conventional Cardiac Arrest Strategy and ROSC has not occurred after >20 minutes, ongoing resuscitation will occur and the patient may be transported via AV to the nearest emergency cardiac catheterisation capable hospital where conventional resuscitation care will continue and Hospital based ECPR may be implemented if the patient meets local eligibility criteria. This is in line with current practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients in each group that are successfully initiated on ECMO.
Proportion of patients in each group that are successfully initiated on ECMO. This will determine if it is feasible to randomise patients to receive either treatment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study startMar 2024 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionDec 2024 (estimated)
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.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Australian and New Zealand Intensive Care Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Ambulance Victoria
- Responsible party
- Sponsor
- Investigators
- Sacha Richardson, MBBS, Principal investigator, The Alfred
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06177730
- Sponsor's protocol ID
- ANZIC-RC/SR001
- Acronym
- PACER
- Status last verified
- Dec 2023
- First submitted
- 11 Dec 2023
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PACER:Pre-hospital ECMO or Conventional Resuscitation for Refractory Cardiac Arrest. An Investigator Initiated, Parallel Group, Assessor-blinded, Registry Embedded, Randomised Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT06177730
- Acronym / sponsor ID
- PACER / ANZIC-RC/SR001
- Conditions
- Out of Hospital Cardiac Arrest
- Keywords
- ECMO, OHCA, pre-hospital, Extracorporeal Membrane Oxygenation, Out of Hospital Cardiac Arrest, ECPR, Extracorproreal Membrane Oxygenation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Australian and New Zealand Intensive Care Research CentreUniversity, hospital or other
- Collaborators
- Ambulance Victoria
- Study start
- Mar 2024 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 20 Dec 2023 (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 pilot study aims to determine feasibility of randomising patients to receive pre-hospital Extracorporeal Cardiopulmonary Resuscitation (ECPR) compared to conventional cardiac arrest care for refractory out of hospital cardiac arrest (OHCA).
The success of this study will be measured by the number of patients recruited into the study successfully treated with the treatment they were randomised to receive in the pre-Hospital setting.
Detailed description
Conventional cardiac arrest care, including high performance cardiopulmonary resuscitation, defibrillation and administration of drugs such as adrenaline is the current treatment for out of hospital cardiac arrest. In cases where this treatment does not see spontaneous circulation restored promptly, the patients cardiac arrest is termed refractory. Refractory Cardiac arrest is coupled with an increased risk of hypoxic injury to vital organs and the prospect of survival with good neurological recovery decreases dramatically.
ECPR is an effective way to restore circulation for patients with refractory OHCA. Hospital based ECPR is the most common process by which refractory OHCA patients are treated with ECPR. Patients are transported to an ECPR capable hospital while receiving mechanical CPR. Transporting patients while receiving mechanical CPR is challenging and may lead to less effective CPR (low flow). It may also delay access to urgent hospital based treatments due to the extra time required to load a patient receiving mechanical CPR.
Pre-Hospital ECPR is where the ECMO team rapidly attends the scene and implements ECMO while CPR is on-going at the scene. Benefits of this approach may include reduced low-flow time due to both earlier ECMO initiation as well as allowing the emergency responders focus on delivering high performance CPR rather than loading the patient for transport.
The results of this study will inform a larger study where researchers will compare these two treatments to determine if ECPR leads to higher survival rates and better recovery for patients with refractory OHCA. Observational data for pre-hospital ECPR in the Australian setting looks promising. However ECPR systems are expensive and resource intensive, making answering this question an imperative.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-hospital ECPR Strategy | Active comparator | Other: Pre-Hospital ECPRAll patients will have high performance CPR at the scene throughout the resuscitation. If the patient is randomised to the Pre-hospital ECPR Strategy, this will be continued until the PACER team arrives. If return of spontaneous circulation (ROSC) has not been achieved at this point, ECPR will be implemented. The patient will be transported to The Alfred Hospital to receive ongoing care. |
| Conventional Cardiac Arrest Strategy | No intervention | –All patients will have high performance CPR at the scene throughout the resuscitation. If the patient has been randomised to the Conventional Cardiac Arrest Strategy and ROSC has not occurred after >20 minutes, ongoing resuscitation will occur and the patient may be transported via AV to the nearest emergency cardiac catheterisation capable hospital where conventional resuscitation care will continue and Hospital based ECPR may be implemented if the patient meets local eligibility criteria. This is in line with current practice. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult patients 18-70 years old
- Witnessed cardiac arrest
- Bystander CPR
- Refractory cardiac arrest (>20 mins, but <45 mins)
- Initial cardiac rhythm VF, VT or PEA
Key exclusion criteria (8 listed)
- Initial cardiac rhythm asystole
- ROSC with sustained recovery
- Technically not possible to perform percutaneous cannulation
- Evidence of/suspectedSignificant end stage disease:
- Severe disability impairing activities of daily living
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 |
|---|---|---|
| Pre-Hospital ECPRImplementation of pre-Hospital ECPr in OHCA | Other | Pre-hospital ECPR Strategy |
Primary outcome
Proportion of patients in each group that are successfully initiated on ECMO.
Time frame: 6 months
Proportion of patients in each group that are successfully initiated on ECMO. This will determine if it is feasible to randomise patients to receive either treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- 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.
Sacha Richardson, MBBS principal investigator
The Alfred
Questions about this trial
What is this clinical trial studying?
A study testing Pre-Hospital ECPR in people with Out of Hospital Cardiac Arrest, run by Australian and New Zealand Intensive Care Research Centre.
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 7 inclusion and 8 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 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Phoebe McCracken (+61 458 154 740, phoebe.mccracken@monash.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients in each group that are successfully initiated on ECMO. (time frame: 6 months). 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 20 Dec 2023.