RecruitingACTRN12625000318482

Pre-hospital Extracorporeal Cardiopulmonary Resuscitation (ECPR) for Refractory Cardiac ArrEst patients (PRE-CARE Study)

Pre-hospital ECPR for Refractory Cardiac ArrEst (PRE-CARE Study)

Sponsor

NSW Ambulance

Enrollment

50 participants

Start Date

Aug 24, 2023

Study Type

Interventional

Conditions

Resuscitation Refractory Cardiac Arrest

Summary

Out of hospital cardiac arrest (OHCA) is the leading cause of death in otherwise healthy adults affecting ~25,000 Australians per year. Even with conventional cardiopulmonary resuscitation (CCPR), survival decreases quickly. After 15 minutes of CCPR the arrest is deemed "refractory", the probability of good functional recovery falls 30 minutes <1% at 30mins. Extracorporeal membrane oxygenation (ECMO) is circulatory support technology. When ECMO is implemented during a cardiac arrest it is termed – Extracorporeal CardioPulmonary Resuscitation or ECPR. Currently, ECPR is implemented at a few large hospitals (5 in Sydney). The best outcomes with ECPR occur when the time from cardiac arrest to ECMO flow are minimised. Pre-hospital ECPR is implementing ECMO at the scene of cardiac arrest and reduces the time from cardiac arrest to ECMO flow. Pre-hospital ECPR services exist in Paris, London, Netherlands, Minnesota and New Mexico and is being trialled in Melbourne. The hypothesis for the trial is that compared with usual care (including hospital-based ECPR), scene-based ECPR is feasible and will increase the rate of neurologically intact survival at discharge in patients with refractory OHCA.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

Cardiac arrest outside hospital is a medical emergency where the heart suddenly stops. Even with CPR, the chances of survival fall rapidly — and after 15 minutes without a heartbeat, meaningful recovery is very unlikely with standard treatment alone. This study is testing whether bringing a powerful heart-lung bypass machine (ECMO) directly to the scene of a cardiac arrest — rather than only having it available at hospitals — can save more lives and reduce brain injury. This pre-hospital ECPR (Extracorporeal Cardiopulmonary Resuscitation) approach already exists in Paris, London, and other cities. The NSW Ambulance study will compare outcomes for patients who receive this scene-based treatment against those transported to a hospital for ECMO. This study enrolls patients during a cardiac arrest emergency — participants must be adults aged 18 to 65, with a witnessed cardiac arrest where CPR was started quickly, the arrest has been ongoing for at least 15 minutes without a return of pulse, and there is still evidence of heart activity. Patients with asystole, traumatic cardiac arrest, or significant other illnesses affecting prognosis are not eligible.

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Interventions

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).

Locations(3)

Westmead Hospital - Westmead

NSW, Australia

Royal Prince Alfred Hospital - Camperdown

NSW, Australia

St Vincent's Hospital (Darlinghurst) - Darlinghurst

NSW, Australia

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