Tiffany Patterson1, Gavin D Perkins2, Jubin Joseph1, Karen Wilson1, Laura Van Dyck3, Steven Robertson3, Hanna Nguyen1, Hannah McConkey1, Mark Whitbread4, Rachael Fothergill4, Joanne Nevett4, Miles Dalby5, Roby Rakhit6, Philip MacCarthy7, Divaka Perera1, Jerry P Nolan8, Simon R Redwood9. 1. Cardiovascular Division, The Rayne Institute BHF Centre of Research Excellence, King's College London, St. Thomas' Hospital, London, UK. 2. Warwick Clinical Trials Unit and Heart of England NHS Foundation Trust, Warwick Medical School, University of Warwick, Coventry, UK. 3. London School Of Hygiene and Tropical Medicine Clinical Trials Unit, London, UK. 4. London Ambulance Service, London, UK. 5. Department of Cardiology, Royal Brompton and Harefield NHS Foundation Trust, Middlesex, UK. 6. Department of Cardiology, Royal Free NHS Foundation Trust, London, UK. 7. Department of Cardiology, King's College Hospital NHS Foundation Trust, London,UK. 8. School of Clinical Sciences, University of Bristol and Department of Anaesthesia, Royal United Hospital, Bath, UK. 9. Cardiovascular Division, The Rayne Institute BHF Centre of Research Excellence, King's College London, St. Thomas' Hospital, London, UK. Electronic address: simon.redwood@gstt.nhs.uk.
Abstract
BACKGROUND: Wide variation exists in inter-hospital survival from out-of-hospital cardiac arrest (OHCA). Regionalisation of care into cardiac arrest centres (CAC) may improve this. We report a pilot randomised trial of expedited transfer to a CAC following OHCA without ST-elevation. The objective was to assess the feasibility of performing a large-scale randomised controlled trial. METHODS:Adult witnessed ventricular fibrillation OHCA of presumed cardiac cause were randomised 1:1 to either: (1) treatment: comprising expedited transfer to a CAC for goal-directed therapy including access to immediate reperfusion, or (2) control: comprising current standard of care involving delivery to the geographically closest hospital. The feasibility of randomisation, protocol adherence and data collection of the primary (30-day all-cause mortality) and secondary (cerebral performance category (CPC)) and in-hospital major cardiovascular and cerebrovascular events (MACCE) clinical outcome measures were assessed. RESULTS:Between November 2014 and April 2016, 118 cases were screened, of which 63 patients (53%) met eligibility criteria and 40 of the 63 patients (63%) were randomised. There were no protocol deviations in the treatment arm. Data collection of primary and secondary outcomes was achieved in 83%. There was no difference in baseline characteristics between the groups: 30-day mortality (Intervention 9/18, 50% vs. Control 6/15, 40%; P=0.73), CPC 1/2 (Intervention: 9/18, 50% vs. Control 7/14, 50%; P>0.99) or MACCE (Intervention: 9/18, 50% vs. Control 6/15, 40%; P=0.73). CONCLUSIONS: These findings support the feasibility and acceptability of conducting a large-scale randomised controlled trial of expedited transfer to CAC following OHCA to address a remaining uncertainty in post-arrest care.
RCT Entities:
BACKGROUND: Wide variation exists in inter-hospital survival from out-of-hospital cardiac arrest (OHCA). Regionalisation of care into cardiac arrest centres (CAC) may improve this. We report a pilot randomised trial of expedited transfer to a CAC following OHCA without ST-elevation. The objective was to assess the feasibility of performing a large-scale randomised controlled trial. METHODS: Adult witnessed ventricular fibrillation OHCA of presumed cardiac cause were randomised 1:1 to either: (1) treatment: comprising expedited transfer to a CAC for goal-directed therapy including access to immediate reperfusion, or (2) control: comprising current standard of care involving delivery to the geographically closest hospital. The feasibility of randomisation, protocol adherence and data collection of the primary (30-day all-cause mortality) and secondary (cerebral performance category (CPC)) and in-hospital major cardiovascular and cerebrovascular events (MACCE) clinical outcome measures were assessed. RESULTS: Between November 2014 and April 2016, 118 cases were screened, of which 63 patients (53%) met eligibility criteria and 40 of the 63 patients (63%) were randomised. There were no protocol deviations in the treatment arm. Data collection of primary and secondary outcomes was achieved in 83%. There was no difference in baseline characteristics between the groups: 30-day mortality (Intervention 9/18, 50% vs. Control 6/15, 40%; P=0.73), CPC 1/2 (Intervention: 9/18, 50% vs. Control 7/14, 50%; P>0.99) or MACCE (Intervention: 9/18, 50% vs. Control 6/15, 40%; P=0.73). CONCLUSIONS: These findings support the feasibility and acceptability of conducting a large-scale randomised controlled trial of expedited transfer to CAC following OHCA to address a remaining uncertainty in post-arrest care.
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