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

NCT03700125 | Completed Results DMC

• 2 other identifiers: 012543244748
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

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).

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)

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• Ambulance Dispatch

  Within 30 minutes of collapse

• Successful Cannulation

  between 31 and 45 minutes; and 46 and 60 minutes.

• Number of Patients With Return of Spontaneous Circulations (ROSC)

  Within 20 minutes of cardiac arrest

• Emergency Call-out Time Frame

  At 30 minutes after cardiac arrest

• Successful Guide Wire Placement

  Up to 30 minutes after cardiac arrest

Study Arms (1)

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

Procedure: ECMO resuscitation

Interventions

ECMO resuscitation PROCEDURE

Extracorporeal Cardio-Pulmonary Resuscitation (ECPR) using ECMO within 30 minutes of cardiac arrest

Also known as: Extracorporeal Membrane Oxygenation

ECMO resuscitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Barts & The London NHS Trust: lead
• Bodychillz Ltd: collaborator
• Maquet Cardiopulmonary GmbH: collaborator
• Stryker Nordic: collaborator
• London's Air Ambulance Charity, Registered Charity (801013): collaborator

Study Sites (2)

St Bartholomew's Hospital

London, EC1 6BQ, United Kingdom

Location

London Ambulance Service Trust

London, SE1 0BW, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 33403364 BACKGROUND

• 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.

  PMID: 39645021 RESULT

MeSH Terms

Conditions

Death, Sudden, Cardiac; Out-of-Hospital Cardiac Arrest; Ventricular Fibrillation

Interventions

Extracorporeal Membrane Oxygenation

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac

Intervention Hierarchy (Ancestors)

Respiratory Therapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative

Results Point of Contact

• Title: Dr Simon Finney
• Organization: Barts Health NHS Trust

simon.finney2@nhs.net

02073777000

Study Officials

• Simon Finney

  Barts & The London NHS Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single centre feasibility study of a complex intervention

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 9, 2018
• Study Start: September 23, 2019
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: August 8, 2025
• Results First Posted: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)