Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000318482
Ethics application status
Approved
Date submitted
15/11/2024
Date registered
16/04/2025
Date last updated
16/04/2025
Date data sharing statement initially provided
16/04/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pre-hospital Extracorporeal Cardiopulmonary Resuscitation (ECPR) for Refractory Cardiac ArrEst patients (PRE-CARE Study)
Scientific title
Pre-hospital ECPR for Refractory Cardiac ArrEst (PRE-CARE Study)
Secondary ID [1] 313223 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Resuscitation 336294 0
Refractory Cardiac Arrest 335520 0
Condition category
Condition code
Emergency medicine 332477 332477 0 0
Resuscitation
Cardiovascular 332086 332086 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Upon arrival of Extracorporeal Cardiopulmonary Resuscitation (ECPR) team (i.e. one critical care paramedic and two senior physicians in pre-hospital and retrieval medicine), participants will be assessed for eligibility according to pre-specified study inclusion and exclusion criteria and document this on a “STOP/GO” checklist. The senior physicians will administer once-off pre-hospital ECPR at scene of cardiac arrest to eligible participants using an ECMO machine. Briefly, the ECMO cannulae will be inserted and once percutaneous dilation and cannulation of the femoral vessels has commenced, the team will proceed to ECMO support in all circumstances. Once ECMO flow is established, the participant will be transported to hospital and receive standard of care treatment (including hospital ECPR and hospitalisation). Pre-hospital ECPR is ceased once hospital ECPR occurs.

Non-eligible participants will continue to receive standard resuscitation per existing NSW Ambulance protocols. Participants will then receive standard of care treatment (including and hospitalisation).
Intervention code [1] 329796 0
Treatment: Other
Comparator / control treatment
Standard resuscitation as per the existing NSW Ambulance protocols at scene of cardiac arrest.
Control group
Active

Outcomes
Primary outcome [1] 339678 0
Survival with favourable neurological outcome at discharge as defined by cerebral performance category (CPC) of 1 or 2.
Timepoint [1] 339678 0
At death or hospital discharge whichever comes first
Secondary outcome [1] 440843 0
Complication directly attributable to ECPR.
Timepoint [1] 440843 0
Daily following enrolment and during hospital admission
Secondary outcome [2] 440844 0
Low flow time
Timepoint [2] 440844 0
From cardiac arrest to hospitalisation
Secondary outcome [3] 440850 0
Number of “false call outs” – where the ECPR team is activated to a non-cardiac arrest
Timepoint [3] 440850 0
At the conclusion of the enrolment period
Secondary outcome [4] 440845 0
Frequency of successful initiation of ECPR per days of service provision
Timepoint [4] 440845 0
At the conclusion of the enrolment period
Secondary outcome [5] 440842 0
Survival to hospital discharge
Timepoint [5] 440842 0
At death or hospital discharge whichever comes first
Secondary outcome [6] 440848 0
Differences in hospital care between scene initiated and hospital initiated ECPR
Timepoint [6] 440848 0
During hospital admission
Secondary outcome [7] 443831 0
Adverse event rate directly attributable to ECPR
Timepoint [7] 443831 0
Daily following enrolment and during hospital admission
Secondary outcome [8] 440849 0
Time between commencement of cannulation and ECPR flows
Timepoint [8] 440849 0
During cardiac arrest

Eligibility
Key inclusion criteria
1. Adults over 18 years of age and under 65 years of age
2. Witnessed cardiac arrest where no flow times can be reliably ascertained and bystander CPR (no flow time < 5 min)
3. Refractory cardiac arrest: the failure of medical professionals to obtain sustained return of spontaneous circulation at the 15th minute of cardiac arrest with a minimum of 3 external defibrillator if indicated
4. Shockable initial rhythm, with End-Tidal CO2 (ETCO2) > 10 mmHg at the time of inclusion
5. PEA initial rhythm, if: signs of life during resuscitation (spontaneous movement, absence of mydriasis and/or pupillary response, spontaneous breathing movements) and: End-Tidal CO2 (ETCO2) >10 mmHg at the time of inclusion
6. Suspected medical cause of the cardiac arrest (traumatic cardiac arrest is excluded)
7. Drug overdoses with suspected cardiotoxic drugs
8. Commencement of ECPR cannulation < 45min from time of cardiac arrest. or if >45min and <60min AND exhibiting signs of life during CPR
9. Cardiac arrest was witnessed and ‘no flow’ times can be reliably ascertained
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Initial rhythm asystole
2. End-Tidal CO2 < 10 mmHg at the time of inclusion
3. Pregnancy
4. Duration > 5 minutes without cardiac massage after collapsing
5. Co-morbidities that compromise the prognosis for short or medium-term survival.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
24/08/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
12
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 27251 0
Westmead Hospital - Westmead
Recruitment hospital [2] 27252 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 27253 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 43335 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 43333 0
2145 - Westmead
Recruitment postcode(s) [3] 43334 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 317665 0
Government body
Name [1] 317665 0
NSW Ministry of Health
Country [1] 317665 0
Australia
Primary sponsor type
Government body
Name
NSW Ambulance
Address
Country
Australia
Secondary sponsor category [1] 319979 0
None
Name [1] 319979 0
Address [1] 319979 0
Country [1] 319979 0
Other collaborator category [1] 283260 0
University
Name [1] 283260 0
University of Sydney/NHMRC CTC
Address [1] 283260 0
Country [1] 283260 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316363 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 316363 0
Ethics committee country [1] 316363 0
Australia
Date submitted for ethics approval [1] 316363 0
Approval date [1] 316363 0
28/06/2023
Ethics approval number [1] 316363 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137658 0
Dr Natalie Kruit
Address 137658 0
Westmead Hospital, Cnr Hawkesbury Road and, Darcy Rd, Westmead NSW 2145
Country 137658 0
Australia
Phone 137658 0
+61 0288905555
Fax 137658 0
Email 137658 0
[email protected]
Contact person for public queries
Name 137659 0
PRE-CARE Trial Coordinator
Address 137659 0
NHMRC Clinical Trials Centre (CTC) at Chris O'Brien Lifehouse, Level 6, 119-143 Missenden Rd, Camperdown NSW 2050
Country 137659 0
Australia
Phone 137659 0
+61 0295625000
Fax 137659 0
Email 137659 0
[email protected]
Contact person for scientific queries
Name 137660 0
PRE-CARE Trial Coordinator
Address 137660 0
NHMRC Clinical Trials Centre (CTC) at Chris O'Brien Lifehouse, Level 6, 119-143 Missenden Rd, Camperdown NSW 2050
Country 137660 0
Australia
Phone 137660 0
+61 0295625000
Fax 137660 0
Email 137660 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.