The CPR, Pre-hospital ECPR and Early Reperfusion Study: A Target Trial Emulation (CHEER4TTE)

The CPR, Pre-hospital ECPR and Early Reperfusion Study: A Target Trial Emulation (CHEER4TTE)

CHEER4TTE is a target trial emulation, designed to simulate a randomised controlled trial by utilising data from pre-existing data sources. The aim is to determine whether prehospital ECPR for refractory out-of-hospital cardiac arrest improves the rate of survival to hospital discharge when compared to conventional cardiac arrest care.

Study Overview

• Status: Active, not recruiting
• Conditions: Out of Hospital Cardiac Arrest; Extracorporeal Cardiopulmonary Resuscitation
• Intervention / Treatment: Other: Extracorporeal cardiopulmonary resuscitation

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia
      • Monash University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with refractory out-of-hospital cardiac arrest in the metropolitan regions of Sydney and Melbourne.

Description

Inclusion Criteria:

• Witnessed cardiac arrest
• Bystander CPR
• Refractory cardiac arrest (failure to achieve sustained ROSC >20 minutes)
• Initial cardiac rhythm VF, VT or PEA
• Within the hours of prehospital ECPR service operation

Exclusion Criteria:

• Initial cardiac rhythm asystole
• ROSC with sustained recovery
• Unable to reach the patient and commence cannulation within 45 minutes of onset of arrest
• Evidence of/suspected end-stage disease:
• severe disability impairing activities of daily living
• end-stage organ disease - cardiac, liver, lung, renal
• other life-limiting diseases, e.g. malignancy, terminal illness
• advance health care directive
• Time periods of advanced public health restrictions in Victoria and NSW due to COVID-19

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prehospital Extracorporeal Cardiopulmonary Resuscitation (ECPR) Strategy; Patients with refractory OHCA treated with scene-based, pre-hospital ECPR (Intervention) will be identified within two studies testing feasibility of prehospital ECPR for refractory OHCA in the metropolitan regions of Melbourne and Sydney. All intra-arrest and post-arrest care follow guidelines based on the Australian and New Zealand Council of Resuscitation recommendations supplemented by the Victorian ECMO Service (VECMOS) guidelines within Victoria and Agency for Clinical Innovation ECMO Clinical Practice Guidelines in NSW.	Other: Extracorporeal cardiopulmonary resuscitation; The Intervention being evaluated is the initiation of extracorporeal cardiopulmonary resuscitation (ECPR) at the scene, in addition to conventional cardiac arrest care.; Other Names: Extracorporeal Cardiopulmonary Resuscitation (ECPR); Prehospital ECPR; Scene based ECPR
Conventional Cardiac Arrest Strategy; Patients with refractory OHCA treated with conventional cardiac arrest strategy (standard care) will be identified within NSW and Victorian Ambulance OHCA Registries. All intra-arrest and post-arrest care for patients in this group follow guidelines based on the Australian and New Zealand Council of Resuscitation recommendations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Survival to hospital discharge	From meeting full eligibility criteria until the date/time of death or hospital discharge, assessed up to 180 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Low flow time	time from onset of arrest to time of ECPR flow, or time of death
ICU length of stay	From the date/time of ICU admission until the date/time of ICU discharge/death, assessed up to 180 days
Mechanical ventilation days	From date/time of mechanical ventilation commencement until date/time of liberation from mechanical ventilation assessed up to 180 days
ECMO complications	From the date/time of commencement of ECMO support until 1 week following the date/time of cessation of ECMO support
Rates of organ and tissue donation in non-survivors	In the 48hours following date/time of death

Collaborators and Investigators

• Sponsor: Australian and New Zealand Intensive Care Research Centre

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: June 9, 2026
• First Submitted That Met QC Criteria: June 30, 2026
• First Posted (Actual): July 1, 2026

Study Record Updates

• Last Update Posted (Actual): July 1, 2026
• Last Update Submitted That Met QC Criteria: June 30, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: ECMO; Extracorporeal membrane oxygenation; OHCA; ECPR; ECMO CPR; at the scene; scene based
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Arrest; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: ANZIC-RC/SR001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No