Pre-hospital ECMO or Conventional Resuscitation for Refractory Cardiac Arrest

NCT ID: NCT06177730

Last Updated: 2023-12-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-31
• Study Completion Date: 2024-12-31

Brief Summary

This pilot study aims to determine feasibility of randomising patients to receive pre-hospital Extracorporeal Cardiopulmonary Resuscitation (ECPR) compared to conventional cardiac arrest care for refractory out of hospital cardiac arrest (OHCA).

The success of this study will be measured by the number of patients recruited into the study successfully treated with the treatment they were randomised to receive in the pre-Hospital setting.

Detailed Description

Conventional cardiac arrest care, including high performance cardiopulmonary resuscitation, defibrillation and administration of drugs such as adrenaline is the current treatment for out of hospital cardiac arrest. In cases where this treatment does not see spontaneous circulation restored promptly, the patients cardiac arrest is termed refractory. Refractory Cardiac arrest is coupled with an increased risk of hypoxic injury to vital organs and the prospect of survival with good neurological recovery decreases dramatically.

ECPR is an effective way to restore circulation for patients with refractory OHCA. Hospital based ECPR is the most common process by which refractory OHCA patients are treated with ECPR. Patients are transported to an ECPR capable hospital while receiving mechanical CPR. Transporting patients while receiving mechanical CPR is challenging and may lead to less effective CPR (low flow). It may also delay access to urgent hospital based treatments due to the extra time required to load a patient receiving mechanical CPR.

Pre-Hospital ECPR is where the ECMO team rapidly attends the scene and implements ECMO while CPR is on-going at the scene. Benefits of this approach may include reduced low-flow time due to both earlier ECMO initiation as well as allowing the emergency responders focus on delivering high performance CPR rather than loading the patient for transport.

The results of this study will inform a larger study where researchers will compare these two treatments to determine if ECPR leads to higher survival rates and better recovery for patients with refractory OHCA. Observational data for pre-hospital ECPR in the Australian setting looks promising. However ECPR systems are expensive and resource intensive, making answering this question an imperative.

Conditions

Out of Hospital Cardiac Arrest

Keywords

ECMO; OHCA; pre-hospital; Extracorporeal Membrane Oxygenation; Out of Hospital Cardiac Arrest; ECPR; Extracorproreal Membrane Oxygenation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Pre-hospital ECPR Strategy

All patients will have high performance CPR at the scene throughout the resuscitation. If the patient is randomised to the Pre-hospital ECPR Strategy, this will be continued until the PACER team arrives. If return of spontaneous circulation (ROSC) has not been achieved at this point, ECPR will be implemented. The patient will be transported to The Alfred Hospital to receive ongoing care.

Group Type: ACTIVE_COMPARATOR

Pre-Hospital ECPR

Intervention Type: OTHER

Implementation of pre-Hospital ECPr in OHCA

Conventional Cardiac Arrest Strategy

All patients will have high performance CPR at the scene throughout the resuscitation. If the patient has been randomised to the Conventional Cardiac Arrest Strategy and ROSC has not occurred after \>20 minutes, ongoing resuscitation will occur and the patient may be transported via AV to the nearest emergency cardiac catheterisation capable hospital where conventional resuscitation care will continue and Hospital based ECPR may be implemented if the patient meets local eligibility criteria. This is in line with current practice.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pre-Hospital ECPR

Implementation of pre-Hospital ECPr in OHCA

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adult patients 18-70 years old
• Witnessed cardiac arrest
• Bystander CPR
• Refractory cardiac arrest (>20 mins, but <45 mins)
• Initial cardiac rhythm VF, VT or PEA
• Within hours of PACER service operation (e.g. mon-fri 0800-1700)
• Within 25 mins of rapid response ambulance (code 1 lights and sirens)

Exclusion Criteria

• Initial cardiac rhythm asystole
• ROSC with sustained recovery
• Technically not possible to perform percutaneous cannulation
• Evidence of/suspectedSignificant end stage disease:
• Severe disability impairing activities of daily living
• End-stage organ - cardiac, liver, lung, renal
• Other life-limiting diseases e.g malignancy, terminal illness
• Advance health care directive (not for resuscitation)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ambulance Victoria

OTHER_GOV

Sponsor Role: collaborator

Australian and New Zealand Intensive Care Research Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sacha Richardson, MBBS

Role: PRINCIPAL_INVESTIGATOR

The Alfred

Central Contacts

Phoebe McCracken

Role: CONTACT

Phone: +61 458 154 740

Email: phoebe.mccracken@monash.edu

Tony Trapani

Role: CONTACT

Phone: 0409798892

Email: tony.trapani@monash.edu

Other Identifiers

ANZIC-RC/SR001

Identifier Type: -

Identifier Source: org_study_id