Death, Sudden, CardiacSUB30NCT03700125
Pre-hospital ECMO in Advanced Resuscitation in Patients With Refractory Cardiac Arrest. ( SUB30 )
A study testing ECMO resuscitation in people with Death, Sudden, Cardiac and Out-Of-Hospital Cardiac Arrest, run by Barts & The London NHS Trust at 2 sites in United Kingdom.
Trial summary
To establish whether a pre-hospital advanced physician/ paramedic cardiac arrest team that is ECMO capable can establish ECMO flow within 30 minutes of collapse. The Sub30 study will investigate the technical and logistical feasibility of instituting pre-hospital Extracorporeal Cardiopulmonary Resuscitation (ECPR)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Death, Sudden, Cardiac, Out-Of-Hospital Cardiac Arrest, Ventricular Fibrillation
- What is being tested?
- ECMO resuscitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 23 Sep 2019to 15 Dec 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients who:
- have a witnessed out-of-hospital cardiac arrest
- a presumed cardiac aetiology to their cardiac arrest
- receive bystander chest compressions within 3 minutes
- remain in cardiac arrest at 20 minutes following the call to the emergency services or fail to sustain ROSC in the pre-hospital setting
Who cannot join
- The following patients will not be suitable for entry into the study:
- Known to be are visibly appear younger than 18 years old or older than 65 years.
- Known or visible advanced pregnancy (when resuscitative hysterotomy should be performed)
- No signs of life (physical movement or breathing) AND evidence of ineffective chest compressions suggested by:
- absence of electrical activity at 20 minutes time out OR
- end tidal carbon dioxide level of less than 1.3 kPa (10 mmHg)
- Evidence from others present at the scene or patient examination that ECMO unlikely to benefit patient (e.g. advanced malignancy, severe frailty).
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
St Bartholomew's Hospital
London, EC1 6BQ
London Ambulance Service Trust
London, SE1 0BW
About this study
Official title: Feasibility Study of a Pre-hospital Extra-corporeal Membrane Oxygenation (ECMO) Capable Advanced Resuscitation Team at Achieving Blood Flow Within 30 Minutes in Patients With Refractory Cardiac Arrest.
To establish whether a pre-hospital advanced physician/ paramedic cardiac arrest team that is ECMO capable can establish ECMO flow within 30 minutes of collapse. The Sub30 study will investigate the technical and logistical feasibility of instituting pre-hospital Extracorporeal Cardiopulmonary Resuscitation (ECPR) within 30 minutes of collapse for selected patients (n=6) in a geographical sector of Greater London. It will achieve this through a unique collaboration between the primary emergency dispatch and response services (London Ambulance Service NHS Trust, LAS), pre-hospital practitioners (LAS and London Air Ambulance) and clinicians in ECMO (Barts Health NHS Trust).
Read the detailed description
Every year, in London, the ambulance service treats over 4,000 patients who have a had a cardiac arrest (or their heart has stopped). Less than 1 in 10 patients survive to get home. Some of those who survive have severe brain damage since their brains did not receive blood and oxygen when their heart was stopped. The ambulance service in London manages to get to a patient, on average, 7 minutes following a 999 call. The paramedics are very skilled in restarting people's hearts and often manage this in less than 10 minutes. However, sometimes it can take much longer or not be possible. The risks of a patient dying or suffering brain damage increase the longer it takes to restart the heart, particularly after about 20-30 minutes. An extracorporeal membrane oxygenation (ECMO) machine may reduce these risks by pumping a patient's blood through an artificial lung and to their vital body organs - temporarily replacing the function of the heart and lungs. The ECMO is used in normal care to support patients after a cardiac arrest once a patient reaches the hospital, but in this study we want to see if the ECMO can be used very soon after the cardiac arrest is reported via the 999 call.
In the Sub30 study, the ECMO team and machine to travel immediately to where the patient collapses rather than wait for the patient to be moved to a hospital. The study hypothesis is that the ECMO will be started faster and that this may improve patient survival and outcomes.
The ECMO team consists of three senior doctors and a paramedic. They attend patients who have collapsed and start ECMO if standard advanced resuscitation techniques fail to restart the heart in 20 minutes. The team will aim to have the ECMO machine started within 30 minutes of the 999 call. The team have achieved this in training and the current study will assess whether it is possible to do this in six patients in real-life.
A target of thirty minutes to achieve ECMO flow or return of spontaneous circulation (ROSC) is less than in published series to date. This can be achieved by:
- integration into an established pre-hospital emergency response services that aggressively pursue ROSC through optimised Advanced Life Support
- immediate deployment of an ECPR-capable cardiac arrest team as a primary resource, as opposed to delayed secondary deployment. Dispatch will be done by the established Advanced Paramedic Practitioner (APP) desk of London Ambulance Service, with the objective to reach the patient within 8-10 minutes of the 999 call.
- early placement of guide-wires into the femoral vessels during on-going conventional CPR, a procedure with low complication risk that does not commit the team to ECPR but will minimise the delay to ECPR support if conventional resuscitative techniques are not successful within 20 minutes
- facilitated guide-wire placement through real-time wireless ultrasound delivered to the operator through augmented reality smart glasses.
Some out of hospital cardiac arrests (OHCA) are irreversible in nature and ECPR would not provide benefit to these patients. The ECPR team will not be task fixated on providing ECPR, but also supportive of the APP primary responders and provide ECPR only in settings of refractory cardiac arrest that fulfils the study criteria, that have been chosen based on best available evidence to identify those patients in whom ECPR is likely to be of benefit.
If pre-hospital ECMO is feasible within 30 minutes of chest compressions starting, then a larger randomised controlled study of clinical and cost effectiveness is merited. Optimisation of the delivery of ECPR is vital, prior to a controlled study, in order to maximise any potential benefits for patients.
Data from Sub30 will inform the design of such studies enabling an estimation of the size of any potential outcome benefits and the likely affordability for a healthcare service.
- Conditions
- Death, Sudden, Cardiac, Out-Of-Hospital Cardiac Arrest, Ventricular Fibrillation, Cardiopulmonary Arrest With Successful Resuscitation
- Being tested
- ECMO resuscitation
- Keywords
- Advanced life support (ALS), Extra-corporeal Membrane Oxygenation Resuscitation (ECMO)
- Medical subject headings
- Death, Sudden, Cardiac, Out-of-Hospital Cardiac Arrest, Ventricular Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECMO resuscitationProcedure or surgery
Also called Extracorporeal Membrane Oxygenation
Extracorporeal Cardio-Pulmonary Resuscitation (ECPR) using ECMO within 30 minutes of cardiac arrest
| Study group | Role | What they receive |
|---|---|---|
| ECMO resuscitation | Experimental | 6 patients who meet the eligibility criteria will be treated by pre-hospital advanced physician/ paramedic cardiac arrest team that is ECMO capable and can establish ECMO flow within 30 minutes of collapse Receives: Procedure: ECMO resuscitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Successfully Established With Pre-hospital ECPR
The primary endpoint is the proportion of patients successfully established with pre-hospital ECPR within 30 minutes of collapse
Measured: Within 30 minutes of collapse
Secondary outcomes (10)
Ambulance Dispatch
Number of patients not dispatched to as travel time too great/team unavailable
Measured: Within 30 minutes of collapse
Successful Cannulation
The number of patients successfully cannulated 31 and 45 minutes
Measured: between 31 and 45 minutes; and 46 and 60 minutes.
Number of Patients With Return of Spontaneous Circulations (ROSC)
The number of patients patients who achieve ROSC prior to the 20 minutes timeout, number of patients in refractory cardiac arrest at 20 minutes in whom ROSC is achieved prior to ECMO flow
Measured: Within 20 minutes of cardiac arrest
Emergency Call-out Time Frame
The time interval between call to the emergency services and ECPR team arrival
Measured: At 30 minutes after cardiac arrest
Successful Guide Wire Placement
The proportion of potentially supportable patients in whom guidewire placement is attempted and achieved
Measured: Up to 30 minutes after cardiac arrest
Incidence of ECPR-related Complications
Assessment of ECPR-related complications, such as incidence of vascular damage, haemorrhage requiring transfusion and new organ dysfunction
Measured: Duration of ECMO run, between 3 - 14 days
Clinical Outcome Via FIM at 3 Months
Assessment of functional status at hospital discharge using the Functional Independence Measure - FIM (18 item scale, measure of dependence. The higher the score, the more independent the patient is in performing the task).
Measured: 3 months
Clinical Outcome Via MRS at 3 Months
Assessment of functional status at hospital discharge using the modified Rankin Scale (MRS) (scale 0-6, measuring the degree of disability or dependence in the daily activities, where 0 is no symptoms and 6 is dead)
Measured: 3 months
Duration of Hospital Stay (ICU)
Assessment of health resources used for the duration of Intensive Care Unit stay
Measured: 1-3 months
Number of Acute Hospital Admissions Post Discharge
Assessment of health resources used for further hospital admissions following discharge.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start23 Sep 2019
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
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 (2)Papers the sponsor has linked to this study.
- Other trials for Death, Sudden, CardiacStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single centre feasibility study of a complex intervention
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Bodychillz Ltd, Maquet Cardiopulmonary GmbH, Stryker Nordic, London's Air Ambulance Charity, Registered Charity (801013)
- Responsible party
- Sponsor
- Investigators
- Simon Finney, Principal investigator, Barts & The London NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03700125
- Sponsor's protocol ID
- 012543
- Other IDs
- 244748
- Acronym
- SUB30
- Status last verified
- Aug 2025
- First submitted
- 2 Oct 2018
- Last updated
- 8 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share study participant data
Publications
Singer B, Reynolds JC, Davies GE, Wrigley F, Whitbread M, Faulkner M, O'Brien B, Proudfoot AG, Mathur A, Evens T, Field J, Monk V, Finney SJ; International ECMO Network (ECMONet). Sub30: Protocol for the Sub30 feasibility study of a pre-hospital Extracorporeal membrane oxygenation (ECMO) capable advanced resuscitation team at achieving blood flow within 30 min in patients with refractory out-of-hospital cardiac arrest. Resusc Plus. 2020 Dec;4:100029. doi: 10.1016/j.resplu.2020.100029. Epub 2020 Oct 8.
PubMed 33403364Singer B, Hla TTW, Abu-Habsa M, Davies G, Wrigley F, Faulkner M, Finney SJ. Sub30: Feasibility study of a pre-hospital extracorporeal membrane oxygenation (ECMO) in patients with refractory out-of-hospital cardiac arrest in London, United Kingdom. Resuscitation. 2025 Feb;207:110455. doi: 10.1016/j.resuscitation.2024.110455. Epub 2024 Dec 5.
PubMed 39645021
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of a Pre-hospital Extra-corporeal Membrane Oxygenation (ECMO) Capable Advanced Resuscitation Team at Achieving Blood Flow Within 30 Minutes in Patients With Refractory Cardiac Arrest.
- ClinicalTrials.gov ID
- NCT03700125
- Acronym / sponsor ID
- SUB30 / 012543
- Conditions
- Death, Sudden, Cardiac, Out-Of-Hospital Cardiac Arrest, Ventricular Fibrillation, Cardiopulmonary Arrest With Successful Resuscitation
- Keywords
- Advanced life support (ALS), Extra-corporeal Membrane Oxygenation Resuscitation (ECMO)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Collaborators
- Bodychillz Ltd, Maquet Cardiopulmonary GmbH, Stryker Nordic, London's Air Ambulance Charity, Registered Charity (801013)
- Study start
- 23 Sep 2019 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 9 Oct 2018 (actual)
- Results
- Posted 7 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To establish whether a pre-hospital advanced physician/ paramedic cardiac arrest team that is ECMO capable can establish ECMO flow within 30 minutes of collapse. The Sub30 study will investigate the technical and logistical feasibility of instituting pre-hospital Extracorporeal Cardiopulmonary Resuscitation (ECPR) within 30 minutes of collapse for selected patients (n=6) in a geographical sector of Greater London. It will achieve this through a unique collaboration between the primary emergency dispatch and response services (London Ambulance Service NHS Trust, LAS), pre-hospital practitioners (LAS and London Air Ambulance) and clinicians in ECMO (Barts Health NHS Trust).
Detailed description
Every year, in London, the ambulance service treats over 4,000 patients who have a had a cardiac arrest (or their heart has stopped). Less than 1 in 10 patients survive to get home. Some of those who survive have severe brain damage since their brains did not receive blood and oxygen when their heart was stopped. The ambulance service in London manages to get to a patient, on average, 7 minutes following a 999 call. The paramedics are very skilled in restarting people's hearts and often manage this in less than 10 minutes. However, sometimes it can take much longer or not be possible. The risks of a patient dying or suffering brain damage increase the longer it takes to restart the heart, particularly after about 20-30 minutes. An extracorporeal membrane oxygenation (ECMO) machine may reduce these risks by pumping a patient's blood through an artificial lung and to their vital body organs - temporarily replacing the function of the heart and lungs. The ECMO is used in normal care to support patients after a cardiac arrest once a patient reaches the hospital, but in this study we want to see if the ECMO can be used very soon after the cardiac arrest is reported via the 999 call.
In the Sub30 study, the ECMO team and machine to travel immediately to where the patient collapses rather than wait for the patient to be moved to a hospital. The study hypothesis is that the ECMO will be started faster and that this may improve patient survival and outcomes.
The ECMO team consists of three senior doctors and a paramedic. They attend patients who have collapsed and start ECMO if standard advanced resuscitation techniques fail to restart the heart in 20 minutes. The team will aim to have the ECMO machine started within 30 minutes of the 999 call. The team have achieved this in training and the current study will assess whether it is possible to do this in six patients in real-life.
A target of thirty minutes to achieve ECMO flow or return of spontaneous circulation (ROSC) is less than in published series to date. This can be achieved by:
- integration into an established pre-hospital emergency response services that aggressively pursue ROSC through optimised Advanced Life Support
- immediate deployment of an ECPR-capable cardiac arrest team as a primary resource, as opposed to delayed secondary deployment. Dispatch will be done by the established Advanced Paramedic Practitioner (APP) desk of London Ambulance Service, with the objective to reach the patient within 8-10 minutes of the 999 call.
- early placement of guide-wires into the femoral vessels during on-going conventional CPR, a procedure with low complication risk that does not commit the team to ECPR but will minimise the delay to ECPR support if conventional resuscitative techniques are not successful within 20 minutes
- facilitated guide-wire placement through real-time wireless ultrasound delivered to the operator through augmented reality smart glasses.
Some out of hospital cardiac arrests (OHCA) are irreversible in nature and ECPR would not provide benefit to these patients. The ECPR team will not be task fixated on providing ECPR, but also supportive of the APP primary responders and provide ECPR only in settings of refractory cardiac arrest that fulfils the study criteria, that have been chosen based on best available evidence to identify those patients in whom ECPR is likely to be of benefit.
If pre-hospital ECMO is feasible within 30 minutes of chest compressions starting, then a larger randomised controlled study of clinical and cost effectiveness is merited. Optimisation of the delivery of ECPR is vital, prior to a controlled study, in order to maximise any potential benefits for patients.
Data from Sub30 will inform the design of such studies enabling an estimation of the size of any potential outcome benefits and the likely affordability for a healthcare service.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single centre feasibility study of a complex intervention
| Arm | Type | Receives |
|---|---|---|
| ECMO resuscitation | Experimental | Procedure: ECMO resuscitation6 patients who meet the eligibility criteria will be treated by pre-hospital advanced physician/ paramedic cardiac arrest team that is ECMO capable and can establish ECMO flow within 30 minutes of collapse |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- have a witnessed out-of-hospital cardiac arrest
- a presumed cardiac aetiology to their cardiac arrest
- receive bystander chest compressions within 3 minutes
- remain in cardiac arrest at 20 minutes following the call to the emergency services or fail to sustain ROSC in the pre-hospital setting
Key exclusion criteria (7 listed)
- Known to be are visibly appear younger than 18 years old or older than 65 years.
- Known or visible advanced pregnancy (when resuscitative hysterotomy should be performed)
- No signs of life (physical movement or breathing) AND evidence of ineffective chest compressions suggested by:
- absence of electrical activity at 20 minutes time out OR
- end tidal carbon dioxide level of less than 1.3 kPa (10 mmHg)
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 |
|---|---|---|
| ECMO resuscitationAlso: Extracorporeal Membrane OxygenationExtracorporeal Cardio-Pulmonary Resuscitation (ECPR) using ECMO within 30 minutes of cardiac arrest | Procedure or surgery | ECMO resuscitation |
Primary outcome
Proportion of Patients Successfully Established With Pre-hospital ECPR
Time frame: Within 30 minutes of collapse
The primary endpoint is the proportion of patients successfully established with pre-hospital ECPR within 30 minutes of collapse
10 secondary outcomes
Ambulance Dispatch
Time frame: Within 30 minutes of collapse
Successful Cannulation
Time frame: between 31 and 45 minutes; and 46 and 60 minutes.
Number of Patients With Return of Spontaneous Circulations (ROSC)
Time frame: Within 20 minutes of cardiac arrest
Emergency Call-out Time Frame
Time frame: At 30 minutes after cardiac arrest
Successful Guide Wire Placement
Time frame: Up to 30 minutes after cardiac arrest
Incidence of ECPR-related Complications
Time frame: Duration of ECMO run, between 3 - 14 days
Clinical Outcome Via FIM at 3 Months
Time frame: 3 months
Clinical Outcome Via MRS at 3 Months
Time frame: 3 months
Duration of Hospital Stay (ICU)
Time frame: 1-3 months
Number of Acute Hospital Admissions Post Discharge
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 33403364Singer B, Reynolds JC, Davies GE, Wrigley F, Whitbread M, Faulkner M, O'Brien B, Proudfoot AG, Mathur A, Evens T, Field J, Monk V, Finney SJ; International ECMO Network (ECMONet). Sub30: Protocol for the Sub30 feasibility study of a pre-hospital Extracorporeal membrane oxygenation (ECMO) capable advanced resuscitation team at achieving blood flow within 30 min in patients with refractory out-of-hospital cardiac arrest. Resusc Plus. 2020 Dec;4:100029. doi: 10.1016/j.resplu.2020.100029. Epub 2020 Oct 8.
- Results publication: PubMed 39645021Singer B, Hla TTW, Abu-Habsa M, Davies G, Wrigley F, Faulkner M, Finney SJ. Sub30: Feasibility study of a pre-hospital extracorporeal membrane oxygenation (ECMO) in patients with refractory out-of-hospital cardiac arrest in London, United Kingdom. Resuscitation. 2025 Feb;207:110455. doi: 10.1016/j.resuscitation.2024.110455. Epub 2024 Dec 5.
- Individual participant dataSharing planned: No. There is no plan to share study participant data
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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.
Simon Finney principal investigator
Barts & The London NHS Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECMO resuscitation in people with Death, Sudden, Cardiac and Out-Of-Hospital Cardiac Arrest, run by Barts & The London NHS Trust at 2 sites in United Kingdom.
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 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 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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 7 Aug 2025). 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?
Proportion of Patients Successfully Established With Pre-hospital ECPR (time frame: Within 30 minutes of collapse). 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 NCT03700125, which also lists 2 linked publications.
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 8 Aug 2025.