NCT03700125: SUB30

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

Completed NA Results posted Last updated 8 August 2025

What this trial tests

NA trial testing ECMO resuscitation in Death, Sudden, Cardiac in 5 participants. Completed in 15 December 2022.

Timeline

23 September 2019

Primary endpoint
15 December 2022

15 December 2022

Quick facts

Lead sponsor	Barts & The London NHS Trust
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	5
Start date	23 September 2019
Primary completion	15 December 2022
Estimated completion	15 December 2022
Sites	2 locations across United Kingdom

Drugs / interventions tested

• ECMO resuscitation

Conditions studied

• Death, Sudden, Cardiac — all drugs for Death, Sudden, Cardiac →
• Out-Of-Hospital Cardiac Arrest — all drugs for Out-Of-Hospital Cardiac Arrest →
• Ventricular Fibrillation — all drugs for Ventricular Fibrillation →
• Cardiopulmonary Arrest With Successful Resuscitation — all drugs for Cardiopulmonary Arrest With Successful Resuscitation →

Sponsor

Barts & The London NHS Trust — full company profile →

Who can join

18 and older, any sex, with Death, Sudden, Cardiac or Out-Of-Hospital Cardiac Arrest. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Proportion of Patients Successfully Established With Pre-hospital ECPR Primary · Within 30 minutes of collapse

The primary endpoint is the proportion of patients successfully established with pre-hospital ECPR within 30 minutes of collapse

Group	Value	95% CI
ECMO Resuscitation	0

Successful Cannulation Secondary · between 31 and 45 minutes; and 46 and 60 minutes.

The number of patients successfully cannulated 31 and 45 minutes

Group	Value	95% CI
ECMO Resuscitation	2

Number of Patients With Return of Spontaneous Circulations (ROSC) Secondary · 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

Group	Value	95% CI
ECMO Resuscitation	0

Emergency Call-out Time Frame Secondary · At 30 minutes after cardiac arrest

The time interval between call to the emergency services and ECPR team arrival

Group	Value	95% CI
ECMO Resuscitation	16	5 – 22

Successful Guide Wire Placement Secondary · Up to 30 minutes after cardiac arrest

The proportion of potentially supportable patients in whom guidewire placement is attempted and achieved

Group	Value	95% CI
ECMO Resuscitation	5

Incidence of ECPR-related Complications Secondary · 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

Group	Value	95% CI
ECMO Resuscitation	1
ECMO Resuscitation	1
ECMO Resuscitation	1
ECMO Resuscitation	2

Clinical Outcome Via MRS at 3 Months Secondary · 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)

Group	Value	95% CI
ECMO Resuscitation	0
ECMO Resuscitation	0
ECMO Resuscitation	0
ECMO Resuscitation	0

Duration of Hospital Stay (ICU) Secondary · 1-3 months

Assessment of health resources used for the duration of Intensive Care Unit stay

Group	Value	95% CI
ECMO Resuscitation	16	2 – 25

Number of Acute Hospital Admissions Post Discharge Secondary · 3 months

Assessment of health resources used for further hospital admissions following discharge.

Group	Value	95% CI
ECMO Resuscitation	0	0 – 0

Adverse events — posted to ClinicalTrials.gov

Time frame: 90 days after study entry. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

ECMO Resuscitation

Serious: 4/5 (80%)

Deaths: 3/5

Serious adverse events (4 terms)

Reaction	System	ECMO Resuscitation
Limb ischaemia	Cardiac disorders	—
Microbubbles in right heart on echo	Cardiac disorders	—
Cannulation site bleeding	Vascular disorders	—
Calibration error on ECMO machine	Product Issues	—

Other adverse events (2 terms — click to expand)

Reaction	System	ECMO Resuscitation
Haemoperitoneum/Haemomediastinum	Cardiac disorders	—
Bleeding following IABP removal	Vascular disorders	—

Most-reported serious reactions: Limb ischaemia, Microbubbles in right heart on echo, Cannulation site bleeding, Calibration error on ECMO machine.

Data from ClinicalTrials.gov NCT03700125 adverse events section.

Sponsor's own description

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).

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Extracorporeal cardiopulmonary resuscitation in adults: evidence and implications.
   Abrams D, MacLaren G, Lorusso R, Price S, et al · · 2022 · cited 179× · PMID 34505911 · DOI 10.1007/s00134-021-06514-y
2. In-Depth Extracorporeal Cardiopulmonary Resuscitation in Adult Out-of-Hospital Cardiac Arrest.
   Dennis M, Lal S, Forrest P, Nichol A, et al · · 2020 · cited 55× · PMID 32375010 · DOI 10.1161/jaha.120.016521
3. 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.
   Singer B, Reynolds JC, Davies GE, Wrigley F, et al · · 2020 · cited 28× · PMID 33403364 · DOI 10.1016/j.resplu.2020.100029
4. ECMO in Cardiac Arrest: A Narrative Review of the Literature.
   De Charrière A, Assouline B, Scheen M, Mentha N, et al · · 2021 · cited 26× · PMID 33540537 · DOI 10.3390/jcm10030534
5. Extracorporeal cardiopulmonary resuscitation for refractory cardiac arrest: a scoping review.
   Miraglia D, Almanzar C, Rivera E, Alonso W. · · 2021 · cited 5× · PMID 33615309 · DOI 10.1002/emp2.12380
6. [Extracorporeal resuscitation-criteria, prerequisites, outcome : A reality check].
   Magnet I, Poppe M. · · 2022 · cited 3× · PMID 35403894 · DOI 10.1007/s00063-022-00913-9