A randomized trial of expedited intra-arrest transfer versus more extended on-scene resuscitation for refractory out of hospital cardiac arrest: Rationale and design of the EVIDENCE trial

Brian Burns; Ian Marschner; Renee Eggins; Hergen Buscher; Rachael L Morton; Jason Bendall; Anthony Keech; Mark Dennis; EVIDENCE Investigators

doi:10.1016/j.ahj.2023.10.003

A randomized trial of expedited intra-arrest transfer versus more extended on-scene resuscitation for refractory out of hospital cardiac arrest: Rationale and design of the EVIDENCE trial

Am Heart J. 2024 Jan:267:22-32. doi: 10.1016/j.ahj.2023.10.003. Epub 2023 Oct 21.

Authors

Brian Burns¹, Ian Marschner², Renee Eggins², Hergen Buscher³, Rachael L Morton², Jason Bendall⁴, Anthony Keech⁵, Mark Dennis⁶; EVIDENCE Investigators

Affiliations

¹ New South Wales Ambulance, Sydney, Australia; Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.
² Faculty of Medicine and Health, The University of Sydney, Sydney, Australia; NHMRC Clinical Trials Centre, The University of Sydney, Sydney Australia.
³ St. Vincent's Hospital, Sydney, Australia; University of New South Wales, Sydney, Australia.
⁴ New South Wales Ambulance, Sydney, Australia.
⁵ Faculty of Medicine and Health, The University of Sydney, Sydney, Australia; Royal Prince Alfred Hospital, Sydney, Australia.
⁶ Faculty of Medicine and Health, The University of Sydney, Sydney, Australia; Royal Prince Alfred Hospital, Sydney, Australia. Electronic address: mark.dennis@sydney.edu.au.

PMID: 37871782
DOI: 10.1016/j.ahj.2023.10.003

Abstract

Background: Refractory Out of Hospital Cardiac Arrest (r-OHCA) is common and the benefit versus harm of intra-arrest transport of patients to hospital is not clear.

Objective: To assess the rate of survival to hospital discharge in adult patients with r-OHCA, initial rhythm pulseless ventricular tachycardia (VT)/ventricular fibrillation (VF) or Pulseless Electrical Activity (PEA) treated with 1 of 2 locally accepted standards of care:¹ expedited transport from scene; or² ongoing advanced life support (ALS) resuscitation on-scene.

Hypothesis: We hypothesize that expedited transport from scene in r-OHCA improves survival with favorable neurological status/outcome.

Methods/design: Phase III, multi-center, partially blinded, prospective, intention-to-treat, safety and efficacy clinical trial with contemporaneous registry of patient ineligible for the clinical trial. Eligible patients for inclusion are adults with witnessed r-OHCA; estimated age 18 to 70, assumed medical cause with immediate bystander cardiopulmonary resuscitation (CPR); initial rhythm of VF/pulseless VT, or PEA; no return of spontaneous circulation following 3 shocks and/or 15 minutes of professional on-scene resuscitation; with mechanical CPR available. Two hundred patients will be randomized in a 1:1 ratio to either expedited transport from scene or ongoing ALS at the scene of cardiac arrest.

Setting: Two urban regions in NSW Australia.

Outcomes: Primary: survival to hospital discharge with cerebral performance category (CPC) 1 or 2. Secondary: safety, survival, prognostic factors, use of ECMO supported CPR and functional assessment at hospital discharge and 4 weeks and 6 months, quality of life, healthcare use and cost-effectiveness.

Conclusions: The EVIDENCE trial will determine the potential risks and benefits of an expedited transport from scene of cardiac arrest.

Publication types

Clinical Trial, Phase III
Multicenter Study
Randomized Controlled Trial

MeSH terms

Adolescent
Adult
Aged
Cardiopulmonary Resuscitation*
Emergency Medical Services*
Humans
Middle Aged
Out-of-Hospital Cardiac Arrest* / therapy
Prospective Studies
Quality of Life
Tachycardia, Ventricular*
Young Adult