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| ID | Type | Description | Link |
|---|---|---|---|
| 244748 | Other Identifier | IRAS |
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| Name | Class |
|---|---|
| Bodychillz Ltd | INDUSTRY |
| Maquet Cardiopulmonary GmbH | INDUSTRY |
| Stryker Nordic | INDUSTRY |
| London's Air Ambulance Charity, Registered Charity (801013) |
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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).
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ECMO resuscitation | Procedure | Extracorporeal Cardio-Pulmonary Resuscitation (ECPR) using ECMO within 30 minutes of cardiac arrest |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Within 30 minutes of collapse |
| Measure | Description | Time Frame |
|---|---|---|
| Ambulance Dispatch | Number of patients not dispatched to as travel time too great/team unavailable | Within 30 minutes of collapse |
| Successful Cannulation | The number of patients successfully cannulated 31 and 45 minutes |
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Inclusion Criteria:
Adult patients who:
Exclusion Criteria:
The following patients will not be suitable for entry into the study:
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| Name | Affiliation | Role |
|---|---|---|
| Simon Finney | Barts & The London NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Bartholomew's Hospital | London | EC1 6BQ | United Kingdom | |||
| London Ambulance Service Trust |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33403364 | Background | 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. | |
| 39645021 |
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There is no plan to share study participant data
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| ID | Title | Description |
|---|---|---|
| FG000 | ECMO Resuscitation | 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 ECMO resuscitation: Extracorporeal Cardio-Pulmonary Resuscitation (ECPR) using ECMO within 30 minutes of cardiac arrest |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 2, 2022 | Feb 13, 2025 |
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| UNKNOWN |
Single centre feasibility study of a complex intervention
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| 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 | Within 20 minutes of cardiac arrest |
| Emergency Call-out Time Frame | The time interval between call to the emergency services and ECPR team arrival | At 30 minutes after cardiac arrest |
| Successful Guide Wire Placement | The proportion of potentially supportable patients in whom guidewire placement is attempted and achieved | 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 | 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). | 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) | 3 months |
| Duration of Hospital Stay (ICU) | Assessment of health resources used for the duration of Intensive Care Unit stay | 1-3 months |
| Number of Acute Hospital Admissions Post Discharge | Assessment of health resources used for further hospital admissions following discharge. | 3 months |
| London |
| SE1 0BW |
| United Kingdom |
| Result |
| Singer 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. |
| COMPLETED |
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| NOT COMPLETED |
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All patients enrolled
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| ID | Title | Description |
|---|---|---|
| BG000 | ECMO Resuscitation | 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 ECMO resuscitation: Extracorporeal Cardio-Pulmonary Resuscitation (ECPR) using ECMO within 30 minutes of cardiac arrest |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | Within 30 minutes of collapse |
|
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| |||||||||||||||||||||||||||
| Secondary | Ambulance Dispatch | Number of patients not dispatched to as travel time too great/team unavailable | The ambulance dispatch centre is very busy with always many calls waiting to be answered. If calls were not within criteria (not cardiac arrests, not suitable, too far away) the call operators moved on to the next call and did not record a non-activation. As the operators did not record the non-activation, it was not feasible to collect these data | Posted | Within 30 minutes of collapse |
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| |||||||||||||||||||||||||||||
| Secondary | Successful Cannulation | The number of patients successfully cannulated 31 and 45 minutes | Posted | Count of Participants | Participants | between 31 and 45 minutes; and 46 and 60 minutes. |
|
| ||||||||||||||||||||||||||||
| Secondary | 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 | Posted | Count of Participants | Participants | Within 20 minutes of cardiac arrest |
|
| ||||||||||||||||||||||||||||
| Secondary | Emergency Call-out Time Frame | The time interval between call to the emergency services and ECPR team arrival | Posted | Median | Full Range | Minutes | At 30 minutes after cardiac arrest |
|
| |||||||||||||||||||||||||||
| Secondary | Successful Guide Wire Placement | The proportion of potentially supportable patients in whom guidewire placement is attempted and achieved | Posted | Count of Participants | Participants | Up to 30 minutes after cardiac arrest |
|
| ||||||||||||||||||||||||||||
| Secondary | Incidence of ECPR-related Complications | Assessment of ECPR-related complications, such as incidence of vascular damage, haemorrhage requiring transfusion and new organ dysfunction | Posted | Count of Participants | Participants | Duration of ECMO run, between 3 - 14 days |
|
| ||||||||||||||||||||||||||||
| Secondary | 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). | 3 patients died and could not be assessed. Remaining 2 patients were no longer in hospital at the planned assessment time. The study team lacked the resource to assess at alternative centres and this feasibility study demonstrated that this measure is complex to collect. Noted as protocol variations. | Posted | 3 months |
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| |||||||||||||||||||||||||||||
| Secondary | 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) | Posted | Count of Participants | Participants | 3 months |
|
| ||||||||||||||||||||||||||||
| Secondary | Duration of Hospital Stay (ICU) | Assessment of health resources used for the duration of Intensive Care Unit stay | Posted | Median | Full Range | days | 1-3 months |
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| |||||||||||||||||||||||||||
| Secondary | Number of Acute Hospital Admissions Post Discharge | Assessment of health resources used for further hospital admissions following discharge. | Posted | Median | Full Range | admissions post discharge | 3 months |
|
|
90 days after study entry
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ECMO Resuscitation | 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 ECMO resuscitation: Extracorporeal Cardio-Pulmonary Resuscitation (ECPR) using ECMO within 30 minutes of cardiac arrest | 3 | 5 | 4 | 5 | 2 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Limb ischaemia | Cardiac disorders | Non-systematic Assessment |
| ||
| Microbubbles in right heart on echo | Cardiac disorders | Non-systematic Assessment |
| ||
| Cannulation site bleeding | Vascular disorders | Non-systematic Assessment |
| ||
| Calibration error on ECMO machine | Product Issues | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemoperitoneum/Haemomediastinum | Cardiac disorders | Non-systematic Assessment |
| ||
| Bleeding following IABP removal | Vascular disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Simon Finney | Barts Health NHS Trust | 02073777000 | simon.finney2@nhs.net |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 10, 2019 | Feb 13, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D016757 | Death, Sudden, Cardiac |
| D058687 | Out-of-Hospital Cardiac Arrest |
| D014693 | Ventricular Fibrillation |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003645 | Death, Sudden |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001145 | Arrhythmias, Cardiac |
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| ID | Term |
|---|---|
| D015199 | Extracorporeal Membrane Oxygenation |
| ID | Term |
|---|---|
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |
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| >=65 years |
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