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Pre-hospital ECMO in Advanced Resuscitation in Patients With Refractory Cardiac Arrest. ( SUB30 ) (SUB30)

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ClinicalTrials.gov Identifier: NCT03700125
Recruitment Status : Not yet recruiting
First Posted : October 9, 2018
Last Update Posted : April 9, 2019
Sponsor:
Collaborators:
London Ambulance Service
Maquet Cardiopulmonary GmbH
Information provided by (Responsible Party):
Barts & The London NHS Trust

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).

Condition or disease Intervention/treatment Phase
Death, Sudden, Cardiac Out-Of-Hospital Cardiac Arrest Ventricular Fibrillation Cardiopulmonary Arrest With Successful Resuscitation Procedure: ECMO resuscitation Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
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.
Estimated Study Start Date : April 15, 2019
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : May 1, 2020


Arm Intervention/treatment
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
Procedure: ECMO resuscitation
Extracorporeal Cardio-Pulmonary Resuscitation (ECPR) using ECMO within 30 minutes of cardiac arrest
Other Name: Extracorporeal Membrane Oxygenation




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Ambulance dispatch [ Time Frame: Within 30 minutes of collapse ]
    Number of patients not dispatched to as travel time too great/team unavailable

  2. Successful cannulation [ Time Frame: between 31 and 45 minutes; and 46 and 60 minutes. ]
    The number of patients successfully cannulated 31 and 45 minutes

  3. Number of patients with return of spontaneous circulations (ROSC) [ Time Frame: Within 20 minutes of cardiac arrest ]
    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

  4. Emergency call-out time frame [ Time Frame: At 30 minutes after cardiac arrest ]
    The time interval between call to the emergency services and ECPR team arrival

  5. Successful guide wire placement [ Time Frame: Up to 30 minutes after cardiac arrest ]
    The proportion of potentially supportable patients in whom guidewire placement is attempted and achieved

  6. Incidence of ECPR-related complications [ Time Frame: Duration of ECMO run, between 3 - 14 days ]
    Assessment of ECPR-related complications, such as incidence of vascular damage, haemorrhage requiring transfusion and new organ dysfunction

  7. Clinical outcome via FIM at 3 months [ Time Frame: 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).

  8. Clinical outcome via MRS at 3 months [ Time Frame: 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)

  9. Duration of hospital stay [ Time Frame: 1-3 months ]
    Assessment of health resources used for the duration of Intensive Care Unit stay

  10. Number of acute hospital admissions post discharge [ Time Frame: 3 months ]
    Assessment of health resources used for further hospital admissions following discharge.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

The following patients will not be suitable for entry into the study:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03700125


Contacts
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Contact: Ben Singer 02034656911 ben.singer@bartshealth.nhs.uk
Contact: Vivienne Monk 0207882 5668 v.monk@qmul.ac.uk

Locations
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United Kingdom
St Bartholomew's Hospital Not yet recruiting
London, United Kingdom, EC1 6BQ
Contact: Ben Singer    0203 4656911    sub30study@bartshealth.nhs.uk   
Principal Investigator: Ben SInger         
Sponsors and Collaborators
Barts & The London NHS Trust
London Ambulance Service
Maquet Cardiopulmonary GmbH
Investigators
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Principal Investigator: Simon Finney Barts & The London NHS Trust

Additional Information:
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Responsible Party: Barts & The London NHS Trust
ClinicalTrials.gov Identifier: NCT03700125     History of Changes
Other Study ID Numbers: 012543
244748 ( Other Identifier: IRAS )
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share study participant data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Barts & The London NHS Trust:
Advanced life support (ALS)
Extra-corporeal Membrane Oxygenation Resuscitation (ECMO)

Additional relevant MeSH terms:
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Heart Arrest
Out-of-Hospital Cardiac Arrest
Ventricular Fibrillation
Death, Sudden
Death, Sudden, Cardiac
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes
Death