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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 - 07/12/23

Doi : 10.1016/j.ahj.2023.10.003 
Brian Burns, MB, BCh a, b, Ian Marschner, PhD b, c, Renee Eggins, MBiostat b, c, Hergen Buscher, EDIC, DEAA d, e, Rachael L. Morton, PhD b, c, Jason Bendall, PhD a, Anthony Keech, MSc b, f, Mark Dennis, PhD b, f,
on behalf of the

EVIDENCE Investigators

a New South Wales Ambulance, Sydney, Australia 
b Faculty of Medicine and Health, The University of Sydney, Sydney, Australia 
c NHMRC Clinical Trials Centre, The University of Sydney, Sydney Australia 
d St. Vincent's Hospital, Sydney, Australia 
e University of New South Wales, Sydney, Australia 
f Royal Prince Alfred Hospital, Sydney, Australia 

Reprint requests: Mark Dennis, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia, Missenden Road, Camperdown, Darlington, NSW 2006 Australia.Faculty of Medicine and Health, The University of Sydney, Sydney, AustraliaMissenden Road, CamperdownDarlingtonNSW2006Australia

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.

Il testo completo di questo articolo è disponibile in PDF.

Abbreviations : AED, ALS, AR-DRGs, ARR, CCL, CEACs, CHeReL, CPC, CPR, ECG, ECPR, ED, EMS, EQ-5D-5L, ETCO2, hpCPR, ICU, IDSMB, ILCOR, MCPR, MOCA, NNT, NSW, OHCA, PAPA, PCI, PEA, PROCAT, QALYs, REDCap, r-OHCA, ROSC, TRGS, VAS, VF, VT


Mappa


 The trial is registered at the Australian Clinical Trial Registry (ACTRN12621000668808).


© 2023  The Author(s). Pubblicato da Elsevier Masson SAS. Tutti i diritti riservati.
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