Condition or disease | Intervention/treatment | Phase |
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Death, Sudden, Cardiac Out-Of-Hospital Cardiac Arrest Ventricular Fibrillation Cardiopulmonary Arrest With Successful Resuscitation | Procedure: ECMO resuscitation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 6 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | Single centre feasibility study of a complex intervention |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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. |
Actual Study Start Date : | September 23, 2019 |
Estimated Primary Completion Date : | May 31, 2021 |
Estimated Study Completion Date : | December 31, 2021 |
Arm | Intervention/treatment |
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Experimental: 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
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Procedure: ECMO resuscitation
Extracorporeal Cardio-Pulmonary Resuscitation (ECPR) using ECMO within 30 minutes of cardiac arrest
Other Name: Extracorporeal Membrane Oxygenation
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adult patients who:
Exclusion Criteria:
The following patients will not be suitable for entry into the study:
United Kingdom | |
St Bartholomew's Hospital | |
London, United Kingdom, EC1 6BQ | |
London Ambulance Service Trust | |
London, United Kingdom, SE1 0BW |
Principal Investigator: | Simon Finney | Barts & The London NHS Trust |
Tracking Information | |||||
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First Submitted Date ICMJE | October 2, 2018 | ||||
First Posted Date ICMJE | October 9, 2018 | ||||
Last Update Posted Date | November 17, 2020 | ||||
Actual Study Start Date ICMJE | September 23, 2019 | ||||
Estimated Primary Completion Date | May 31, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Pre-hospital ECMO in Advanced Resuscitation in Patients With Refractory Cardiac Arrest. ( SUB30 ) | ||||
Official Title ICMJE | 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. | ||||
Brief 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) 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:
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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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: Single centre feasibility study of a complex intervention Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Procedure: ECMO resuscitation
Extracorporeal Cardio-Pulmonary Resuscitation (ECPR) using ECMO within 30 minutes of cardiac arrest
Other Name: Extracorporeal Membrane Oxygenation
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Study Arms ICMJE | Experimental: 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
Intervention: Procedure: ECMO resuscitation
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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. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Estimated Enrollment ICMJE |
6 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 31, 2021 | ||||
Estimated Primary Completion Date | May 31, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria: Adult patients who:
Exclusion Criteria: The following patients will not be suitable for entry into the study:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United Kingdom | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03700125 | ||||
Other Study ID Numbers ICMJE | 012543 244748 ( Other Identifier: IRAS ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Barts & The London NHS Trust | ||||
Study Sponsor ICMJE | Barts & The London NHS Trust | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Barts & The London NHS Trust | ||||
Verification Date | November 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |