Tiffany Patterson1, Alexander Perkins2, Gavin D Perkins3, Tim Clayton2, Richard Evans2, Hanna Nguyen4, Karen Wilson4, Mark Whitbread5, Johanna Hughes5, Rachael T Fothergill6, Joanne Nevett5, Iris Mosweu7, Paul McCrone7, Miles Dalby8, Roby Rakhit9, Philip MacCarthy10, Divaka Perera4, Jerry P Nolan11, Simon R Redwood4. 1. Cardiovascular Division, The Rayne Institute BHF Centre of Research Excellence, King's College London, St. Thomas' Hospital, London, UK. Electronic address: tiffanypatterson05@gmail.com. 2. London School of Hygiene and Tropical Medicine Clinical Trials Unit, London, UK. 3. Warwick Clinical Trials Unit and Heart of England NHS Foundation Trust, Warwick Medical School, University of Warwick, Coventry, UK. 4. Cardiovascular Division, The Rayne Institute BHF Centre of Research Excellence, King's College London, St. Thomas' Hospital, London, UK. 5. Medical Directorate, London Ambulance Service, London, UK. 6. Warwick Clinical Trials Unit and Heart of England NHS Foundation Trust, Warwick Medical School, University of Warwick, Coventry, UK; Medical Directorate, London Ambulance Service, London, UK. 7. King's Health Economics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, UK. 8. Department of Cardiology, Royal Brompton and Harefield NHS Foundation Trust, Middlesex, UK. 9. Department of Cardiology, Royal Free NHS Foundation Trust, London, UK. 10. Department of Cardiology, King's College Hospital NHS Foundation Trust, London, UK. 11. School of Clinical Sciences, University of Bristol and Department of Anaesthesia, Royal United Hospital, Bath, UK.
Abstract
BACKGROUND: Out-of-hospital cardiac arrest (OHCA) is a global public health issue. There is wide variation in both regional and inter-hospital survival rates from OHCA and overall survival remains poor at 7%. Regionalization of care into cardiac arrest centers (CAC) improves outcomes following cardiac arrest from ST elevation myocardial infarction (STEMI) through concentration of services and greater provider experience. The International Liaison Committee on Resuscitation (ILCOR) recommends delivery of all post-arrest patients to a CAC, but that randomized controlled trials are necessary in patients without ST elevation (STE). METHODS/ DESIGN: Following completion of a pilot randomized trial to assess safety and feasibility of conducting a large-scale randomized controlled trial in patients following OHCA of presumed cardiac cause without STE, we present the rationale and design of A Randomized tRial of Expedited transfer to a cardiac arrest center for non-ST elevation OHCA (ARREST). In total 860 patients will be enrolled and randomized (1:1) to expedited transfer to CAC (24/7 access to interventional cardiology facilities, cooling and goal-directed therapies) or to the current standard of care, which comprises delivery to the nearest emergency department. Primary outcome is 30-day all-cause mortality and secondary outcomes are 30-day and 3-month neurological status and 3, 6 and 12-month mortality. Patients will be followed up for one year after enrolment. CONCLUSION: Post-arrest care is time-critical, requires a multi-disciplinary approach and may be more optimally delivered in centers with greater provider experience. This trial would help to demonstrate if regionalization of post-arrest care to CACs reduces mortality in patients without STE, which could dramatically reshape emergency care provision.
RCT Entities:
BACKGROUND: Out-of-hospital cardiac arrest (OHCA) is a global public health issue. There is wide variation in both regional and inter-hospital survival rates from OHCA and overall survival remains poor at 7%. Regionalization of care into cardiac arrest centers (CAC) improves outcomes following cardiac arrest from ST elevation myocardial infarction (STEMI) through concentration of services and greater provider experience. The International Liaison Committee on Resuscitation (ILCOR) recommends delivery of all post-arrest patients to a CAC, but that randomized controlled trials are necessary in patients without ST elevation (STE). METHODS/ DESIGN: Following completion of a pilot randomized trial to assess safety and feasibility of conducting a large-scale randomized controlled trial in patients following OHCA of presumed cardiac cause without STE, we present the rationale and design of A Randomized tRial of Expedited transfer to a cardiac arrest center for non-ST elevation OHCA (ARREST). In total 860 patients will be enrolled and randomized (1:1) to expedited transfer to CAC (24/7 access to interventional cardiology facilities, cooling and goal-directed therapies) or to the current standard of care, which comprises delivery to the nearest emergency department. Primary outcome is 30-day all-cause mortality and secondary outcomes are 30-day and 3-month neurological status and 3, 6 and 12-month mortality. Patients will be followed up for one year after enrolment. CONCLUSION: Post-arrest care is time-critical, requires a multi-disciplinary approach and may be more optimally delivered in centers with greater provider experience. This trial would help to demonstrate if regionalization of post-arrest care to CACs reduces mortality in patients without STE, which could dramatically reshape emergency care provision.
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