Trial Outcomes & Findings for Pre-hospital ECMO in Advanced Resuscitation in Patients With Refractory Cardiac Arrest. ( SUB30 ) (NCT NCT03700125)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

5 participants

Primary outcome timeframe

Within 30 minutes of collapse

Results posted on

2025-08-08

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ECMO Resuscitation n=5 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United Kingdom	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within 30 minutes of collapse

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

Outcome measures

Outcome measures
Measure	ECMO Resuscitation n=5 Participants 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
Proportion of Patients Successfully Established With Pre-hospital ECPR	0 Participants

SECONDARY outcome

Timeframe: Within 30 minutes of collapse

Population: 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

Number of patients not dispatched to as travel time too great/team unavailable

Outcome measures

Outcome data not reported

SECONDARY outcome

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

The number of patients successfully cannulated 31 and 45 minutes

Outcome measures

Outcome measures
Measure	ECMO Resuscitation n=5 Participants 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
Successful Cannulation	2 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	ECMO Resuscitation n=5 Participants 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
Number of Patients With Return of Spontaneous Circulations (ROSC)	0 Participants

SECONDARY outcome

Timeframe: At 30 minutes after cardiac arrest

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

Outcome measures

Outcome measures
Measure	ECMO Resuscitation n=5 Participants 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
Emergency Call-out Time Frame	16 Minutes Interval 5.0 to 22.0

SECONDARY outcome

Timeframe: Up to 30 minutes after cardiac arrest

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

Outcome measures

Outcome measures
Measure	ECMO Resuscitation n=5 Participants 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
Successful Guide Wire Placement	5 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	ECMO Resuscitation n=5 Participants 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
Incidence of ECPR-related Complications Limb ischaemia	1 Participants
Incidence of ECPR-related Complications Cannulation site bleeding	1 Participants
Incidence of ECPR-related Complications Microbubbles in right heart	1 Participants
Incidence of ECPR-related Complications No ECPR serios event	2 Participants

SECONDARY outcome

Timeframe: 3 months

Population: 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.

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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	ECMO Resuscitation n=5 Participants 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
Clinical Outcome Via MRS at 3 Months 0	0 Participants
Clinical Outcome Via MRS at 3 Months 1	0 Participants
Clinical Outcome Via MRS at 3 Months 2	0 Participants
Clinical Outcome Via MRS at 3 Months 3	0 Participants
Clinical Outcome Via MRS at 3 Months 4	1 Participants
Clinical Outcome Via MRS at 3 Months 5	1 Participants
Clinical Outcome Via MRS at 3 Months 6	3 Participants

SECONDARY outcome

Timeframe: 1-3 months

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

Outcome measures

Outcome measures
Measure	ECMO Resuscitation n=5 Participants 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
Duration of Hospital Stay (ICU)	16 days Interval 2.0 to 25.0

SECONDARY outcome

Timeframe: 3 months

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

Outcome measures

Outcome measures
Measure	ECMO Resuscitation n=2 Participants 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
Number of Acute Hospital Admissions Post Discharge	0 admissions post discharge Interval 0.0 to 0.0

Adverse Events

ECMO Resuscitation

Serious events: 4 serious events

Other events: 2 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	ECMO Resuscitation n=5 participants at risk 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
Cardiac disorders Limb ischaemia	20.0% 1/5 • Number of events 1 • 90 days after study entry
Cardiac disorders Microbubbles in right heart on echo	20.0% 1/5 • Number of events 1 • 90 days after study entry
Vascular disorders Cannulation site bleeding	20.0% 1/5 • Number of events 1 • 90 days after study entry
Product Issues Calibration error on ECMO machine	20.0% 1/5 • Number of events 1 • 90 days after study entry

Other adverse events

Other adverse events
Measure	ECMO Resuscitation n=5 participants at risk 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
Cardiac disorders Haemoperitoneum/Haemomediastinum	20.0% 1/5 • Number of events 1 • 90 days after study entry
Vascular disorders Bleeding following IABP removal	20.0% 1/5 • Number of events 1 • 90 days after study entry

Additional Information

Dr Simon Finney

Barts Health NHS Trust

Phone: 02073777000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place